[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-colorectal-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-colorectal-adenocarcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,41,69,90,129,158,205,227,249],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100490978","phase-3-testing-the-addition-of-total-ablative-therapy-to-usual-systemic-therapy-treatment-for-limited-metastatic-colorectal-cancer-the-erasur-study-100490978",false,"NCT05673148","Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, The ERASur Study","A Pragmatic Randomized Phase III Trial Evaluating Total Ablative Therapy for Patients With Limited Metastatic Colorectal Cancer: Evaluating Radiation, Ablation, and Surgery (ERASur)","Inclusion Criteria:\n\n* PRE-REGISTRATION (STEP 0): Histologically-confirmed metastatic colorectal adenocarcinoma\n* PRE-REGISTRATION (STEP 0): No known microsatellite instable (MSI) tumor\n* PRE-REGISTRATION (STEP 0): No known BRAF V600E mutation\n* PRE-REGISTRATION (STEP 0): Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. No known peritoneal and\u002For omental metastases. If radiologic studies suggest the presence of peritoneal disease, a diagnostic laparoscopy is recommended to verify the absence of peritoneal implants\n* PRE-REGISTRATION (STEP 0): Primary tumor is already resected OR primary tumor is surgically amenable to resection, as determined by consultation and documentation with surgeon or documentation of discussion in the institutional multi-disciplinary tumor board where a surgeon confirms resectability. Patients with unresectable primary tumors are not eligible\n* PRE-REGISTRATION (STEP 0): Four (4) or fewer apparent sites of metastatic disease based on review by local medical team of baseline radiographic imaging obtained prior to initiation of systemic therapy.\n\n  * Sites of metastatic disease must be radiographically evident, but pathologic confirmation is not required.\n  * Liver-only metastatic disease is NOT permitted. For patients with liver metastases, there must be at least one other site of metastasis in addition to the liver to be eligible for this study.\n  * Metastatic lesions must be amenable to any combination of surgical resection, microwave ablation, and\u002For stereotactic ablative body radiation therapy (SABR). SABR is required for at least one lesion. Therefore, the patient must be seen by a radiation oncologist in consultation to verify eligibility.\n  * Single sites include:\n\n    * Each hemiliver (right and left), each lobe of the lungs, each adrenal gland, lymph nodes amenable to a single resection or treatment in a single SABR field, bone metastases amenable to treatment in a single SABR field\n* PRE-REGISTRATION (STEP 0): Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1\n* PRE-REGISTRATION (STEP 0): A maximum of 16 weeks (4 months) of systemic therapy may be administered prior to pre-registration\n* REGISTRATION (STEP 1): Patients must have no overt evidence of disease progression during systemic therapy prior to registration\n* REGISTRATION (STEP 1): Not eligible for hepatic artery infusion pump (HAIP) therapy or benefit of HAIP therapy is undefined\n* REGISTRATION (STEP 1): Patients must have measurable disease per RECIST v1.1\n* REGISTRATION (STEP 1): Patients must be receiving (or have received) first-line systemic therapy for metastatic disease for a minimum of 16 weeks (4 months) and a maximum of 24 weeks (6 months)\n* REGISTRATION (STEP 1): Prior definitive therapy, including adjuvant chemotherapy, must have been completed at least 12 months prior to diagnosis of metastatic disease\n* REGISTRATION (STEP 1): Not pregnant and not nursing, because this study involves an agent or treatment that has known genotoxic, mutagenic, and teratogenic effects.\n\n  \\* Therefore, for women of childbearing potential only, a negative pregnancy test done =\\\u003C 14 days prior to registration is required\n* REGISTRATION (STEP 1): Age \\>= 18 years\n* REGISTRATION (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status: 0-2\n* REGISTRATION (STEP 1): Absolute neutrophil count (ANC) \\>= 1,500\u002Fmm\\^3\n* REGISTRATION (STEP 1): Platelet count \\>= 50,000\u002Fmm\\^3\n* REGISTRATION (STEP 1): Creatinine =\\\u003C 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance \\>= 30 mL\u002Fmin\n\n  \\* Calculated using the Cockcroft-Gault equation\n* REGISTRATION (STEP 1): Total bilirubin =\\\u003C 1.5 x ULN\n* REGISTRATION (STEP 1): Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase \\[SGOT\\]) \u002F alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3.0 x ULN\n\n  \\* In the event of metastatic liver disease, =\\\u003C 5 x ULN\n* REGISTRATION (STEP 1): Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Note: HIV testing is not required for eligibility\n* REGISTRATION (STEP 1): No other planned concurrent investigational agents while on study\n\nExclusion Criteria:\n\n* N\u002FA","ALL","18 Years",{"count":19,"type":20},364,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This phase III trial compares total ablative therapy and usual systemic therapy to usual systemic therapy alone in treating patients with colorectal cancer that has spread to up to 4 body sites (limited metastatic). The usual approach for patients who are not participating in a study is treatment with intravenous (IV) (through a vein) and\u002For oral medications (systemic therapy) to help stop the cancer sites from getting larger and the spread of the cancer to additional body sites. Ablative means that the intention of the local treatment is to eliminate the cancer at that metastatic site. The ablative local therapy will consist of very focused, intensive radiotherapy called stereotactic ablative radiotherapy (SABR) with or without surgical resection and\u002For microwave ablation, which is a procedure where a needle is temporarily inserted in the tumor and heat is used to destroy the cancer cells. SABR, surgical resection, and microwave ablation have been tested for safety, but it is not scientifically proven that the addition of these treatments are beneficial for your stage of cancer. The addition of ablative local therapy to all known metastatic sites to the usual approach of systemic therapy could shrink or remove the tumor(s) or prevent the tumor(s) from returning.",[26,27],"Metastatic Colorectal Adenocarcinoma","Stage IV Colorectal Cancer AJCC v8","RECRUITING","2026-07-01",{"date":31,"type":32},"2026-07-02","ACTUAL",{"date":34,"type":32},"2023-10-09",{"date":36,"type":20},"2032-08-12",{"name":38,"class":39},"Alliance for Clinical Trials in Oncology","OTHER",186,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":68},"100604262","phase-1-testing-the-effectiveness-of-the-anti-cancer-drug-pidnarulex-cx-5461-in-combination-with-another-anti-cancer-drug-cemiplimab-regn2810-in-treating-refractory-microsatellite-stable-colorectal-cancer-100604262","NCT07147231","Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cemiplimab (REGN2810), in Treating Refractory Microsatellite Stable Colorectal Cancer","A Phase 1 and Randomized Phase 2 Trial of Pidnarulex (CX-5461) and Cemiplimab (REGN2810) in Refractory Microsatellite Stable Colorectal Cancer","Inclusion Criteria:\n\n* Patients must have pathologically confirmed colorectal adenocarcinoma that is unresectable and\u002For metastatic and for which standard curative or palliative measures do not exist or are no longer effective\n* Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1\n* Patients must have pathologically confirmed proficient mismatch repair proteins (pMMR) and\u002For not microsatellite-high status (non-MSI-H). This may be confirmed by local tissue testing of the primary tumor and\u002For any metastatic lesion utilizing approved immunohistochemistry (for mismatch repair status) and\u002For polymerase chain reaction or next generation sequencing (for microsatellite status) assays. Historical (i.e., previously obtained) biopsy mismatch repair (MMR) and microsatellite instability (MSI) status may be utilized. If historical tissue is available, MMR and\u002For MSI testing may be performed on that tissue if not done previously. Clinical documentation of the patient's MMR and\u002For MSI status in the medical record may also be utilized to determine MMR and\u002For MSI status for the purposes of eligibility. pMMR results for eligibility testing must be available prior to study enrollment and no eligibility testing will be conducted on study\n* Phase 2 patients must have at least one liver metastasis at study entry (by imaging and\u002For histology, per investigator assessment); this metastasis does not need to be measurable\n* Phase 2 patients must have local\u002Fstandard of care tumor molecular testing (tumor tissue or circulating tumor DNA) demonstrating MYC amplification or deleterious\u002Flikely deleterious FBXW7 mutation, as defined in the report\n* Phase 2 patients must have at least one tumor lesion amenable to biopsy\n* Patients must undergo a washout period of 28 days for epidermal growth factor receptor (EGFR) inhibitors, including cetuximab and panitumumab\n* Patients must have progressed on or have intolerance to (if eligible and not contraindicated per treating investigator) fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab, and epidermal growth factor receptor (EGFR) inhibitor. These are standard of care treatments for this patient population with proven survival benefit, so it would not be appropriate for patients to enroll in this trial without this criterion being met. Subsequent standard of care treatments (trifluridine\u002Ftipiracil, fruquintinib, and regorafenib) have a very modest improvement on survival of only a few months compared to placebo and thus clinical trial options are commonly sought after oxaliplatin and irinotecan but before these other agents\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of pidnarulex (CX-5461) in combination with cemiplimab in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)\n* Absolute neutrophil count ≥ 1,500\u002FmcL\n* Platelets ≥ 100,000\u002FmcL\n* Hemoglobin ≥ 9 g\u002FdL\n* Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level of up to 3 mg\u002Fdl may be enrolled)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 × institutional ULN, (5 × ULN for patients with liver involvement)\n* Glomerular filtration rate (GFR) ≥ 50 mL\u002Fmin\u002F1.73 m\\^2\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression for ≥ 1 month after treatment of the brain metastases\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* The effects of that pidnarulex (CX-5461) on the developing human fetus are unknown. Based on its mechanism of action, cemiplimab (REGN2810) can cause fetal harm when administered to a pregnant woman. Animal studies have demonstrated that inhibition of the PD-1\u002FPD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death. For these reasons, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) 14 days prior to study entry, for the duration of study participation and for at least 4 months after the last dose of cemiplimab (REGN2810) and 6 months after the last dose of pidnarulex (CX-5461). Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study intervention. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Women should not breastfeed while taking cemiplimab (REGN2810) for at least 4 months after cessation of treatment, and for pidnarulex (CX-5461), for 6 months after cessation of treatment. Women should not donate eggs for 14 days prior to the study, for the duration of study participation, and 6 months after completion of pidnarulex (CX-5461) and cemiplimab (REGN2810). Male patients must also agree to not donate sperm for 14 days prior to the study, for the duration of study participation, and 6 months after completion of pidnarulex (CX-5461) and cemiplimab (REGN2810) administration\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Patients with active autoimmune diseases, defined as requiring systemic treatment in the past 2 years with use of disease modifying agents, corticosteroids, or immunosuppressive drugs. Replacement therapy (eg; thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment\n* Patients with prior treatment with an RNA polymerase inhibitor, G quadruplex stabilizer, or immunotherapy. This includes prior treatment with a PD-1 or PD-L1 inhibitor agent\n* Presence of known photosensitivity disorders\n\n  * Patients who do not agree to use sunglasses and sunscreen (≥ sun protective factor (SPF) 50 to ultraviolet B (UVB) and a high degree of protection against ultraviolet A (UVA) if exposed to sunlight during the study and for 4 weeks after the last dose are not eligible. Patients may also not use sun tanning beds during the study, and within 4 weeks after the last dose\n* Patients with a history of cicatricial conjunctivitis or active ocular surface disease (as evaluated by ophthalmologist as needed; routine eye exam for all study participants is not needed)\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Patients who are receiving any other investigational agents\n* Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to pidnarulex (CX-5461) and cemiplimab\n* Patients who use strong CYP3A4 inhibitors or strong CYP3A4 inducers. Pidnarulex (CX-5461) has been shown to be metabolized primarily by the CYP3A4 enzyme. Inhibitors and substrates of these enzymes can increase pidnarulex (CX-5461) plasma concentrations while inducers of these enzymes can decrease pidnarulex (CX-5461) plasma concentrations\n* Patients who are taking corticosteroids at a dose greater than 10 mg of prednisone daily or other immunosuppressive or disease-modifying agents, as this may reduce efficacy of an immunotherapy regimen\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Pregnant and lactating women are excluded from this study. The exclusion is based on the potential risk of adverse effects of pidnarulex (CX-5461) on fetal development and newborn health. The safety of pidnarulex (CX-5461) has not been established in pregnant or lactating women, and there is a possibility that the drug could cause harm to the developing fetus or be transferred to the infant through breast milk. Additionally, the physiological changes that occur during pregnancy and lactation could alter the pharmacokinetics and pharmacodynamics of pidnarulex (CX-5461), leading to unpredictable drug exposure and efficacy. There is also an increased risk of immune-mediated rejection of the developing fetus with cemiplimab (REGN2810)",{"count":49,"type":20},86,[51,52],"PHASE1","PHASE2","This phase I\u002FII trial studies the side effects and best dose of pidnarulex when given together with cemiplimab and to see how well it works in treating patients with microsatellite stable (MSS) colorectal cancer (CRC) that does not respond to treatment (refractory). Pidnarulex may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pidnarulex with cemiplimab may be safe, tolerable and\u002For effective in treating patients with refractory MSS CRC.",[26,55,56,27,57],"Refractory Colorectal Adenocarcinoma","Stage III Colorectal Cancer AJCC v8","Unresectable Colorectal Adenocarcinoma","2026-06-26",{"date":60,"type":32},"2026-06-29",{"date":62,"type":20},"2026-12-21",{"date":64,"type":20},"2027-09-30",{"name":66,"class":67},"National Cancer Institute (NCI)","NIH",5,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},"100569632","phase-1-clinical-trial-of-an-anti-cancer-drug-ca-4948-emavusertib-in-combination-with-chemotherapy-treatment-folfox-plus-bevacizumab-in-metastatic-colorectal-cancer-100569632","NCT06696768","Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer","Phase I Clinical Trial of CA-4948 (Emavusertib) in Combination With FOLFOX Plus Bevacizumab as Frontline Treatment in Patients With Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed colorectal adenocarcinoma\n* Patients must have unresectable or metastatic measurable disease on imaging for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 determination within 28 days of registration\n* For patients enrolling to the expansion cohort, lesions must be amenable to research biopsy\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of CA-4948 (emavusertib) and FOLFOX in combination with bevacizumab in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (or Karnofsky ≥ 60%)\n* Absolute neutrophil count ≥ 1,500\u002FmcL (within 28 days of registration)\n* Platelets ≥ 75,000\u002FmcL (within 28 days of registration)\n* Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN) (within 28 days of registration)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 × institutional ULN; for those with liver metastases, 5 × institutional ULN (within 28 days of registration)\n* Estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73 m\\^2 (within 28 days of registration)\n* Creatine phosphokinase (CPK) elevation at screening \\\u003C grade 2 (CPK ≤ 2.5 x ULN) (within 28 days of registration)\n* Patients on a cholesterol lowering statin must be on a stable dose with no dose changes within 3 weeks prior to study start\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible, after discussion with the principal investigator (PI) or medical monitor, if the treating physician determines that immediate CNS-specific treatment is not required and is unlikely to be required during the first cycle of therapy\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* Patients must be able to take oral medications\n* The effects of CA-4948 (emavusertib) on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Women of childbearing potential must continue contraception for 9 months following the last dose of study drugs. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Males treated or enrolled on this protocol and involved with women of childbearing potential must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 months following the last dose of study drugs\n* Patients must have the ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Patients with high-frequency microsatellite instability (MSI-H) or deficient deoxyribonucleic acid (DNA) mismatch repair (dMMR) colorectal cancer at pre-enrollment screening\n* Patients with prolonged QT interval by Fridericia's correction formula (QTcF) (\\> 450ms) on screening electrocardiogram (ECG)\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1), with the exception of alopecia\n* Patients who are receiving any other investigational agents\n* Patients who have received prior treatment with any chemotherapy (either in the adjuvant or metastatic setting), including FOLFOX, fluorouracil\u002Fleucovorin\u002Firinotecan (FOLFIRI), folinic acid\u002Ffluorouracil\u002Foxaliplatin\u002Firinotecan (FOLFOXIRI), or antiangiogenic agents such as bevacizumab and similar agents, are not eligible for this study\n* Patients with a known dihydropyrimidine dehydrogenase deficiency\n* Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to CA-4948 (emavusertib) or other agents used in the study\n* Patients with a gastrointestinal (GI) condition that could impair absorption of CA-4948 (emavusertib) or cause an inability to ingest CA-4948 (emavusertib)\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Pregnant women are excluded from this study because CA-4948 (emavusertib) is a blood-brain barrier penetrant with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CA-4948 (emavusertib), breastfeeding should be discontinued if the mother is treated with CA-4948 (emavusertib). These potential risks may also apply to other agents used in this study. Women of childbearing potential must have a negative pregnancy test within 7 days of study entry\n* Patients with a history of allogeneic organ or stem cell transplantation\n* Patients with significant active bleeding or those in whom the treating physician believes bevacizumab would not be safe or appropriate\n* Patients who have had palliative radiation to bone metastases within 2 weeks prior to day 1 of the study treatment\n* Patients who have had a major surgical procedure within 4 weeks prior to day 1 of the study treatment\n* Patients with hypertension not controlled by antihypertensive medication\n* Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \\[anti-TNF\\] agents) within 14 days prior to randomization; however,\n\n  * Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea; or chronic daily treatment with corticosteroids with a dose of ≤ 10 mg\u002Fday methylprednisolone equivalent) may be enrolled\n  * The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed\n* Severe infections within 28 days prior to registration, including but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia. This includes receipt of oral or IV antibiotics within 14 days prior to registration. Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible",{"count":77,"type":20},24,[51],"This phase I trial studies the side effects and best dose of CA-4948 when given together with fluorouracil, leucovorin, oxaliplatin (FOLFOX) plus bevacizumab in treating patients with colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic). CA-4948 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The chemotherapy drugs used in FOLFOX, fluorouracil and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Leucovorin is used with fluorouracil to treat colorectal cancer. Bevacizumab is in a class of medications called anti-angiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to the tumor. This may slow the growth and spread of the tumor. Giving CA-4948 with FOLFOX plus bevacizumab may be safe, tolerable and\u002For effective in treating patients with metastatic colorectal cancer.",[26,56,27,57],"2026-06-02",{"date":83,"type":32},"2026-06-03",{"date":85,"type":32},"2025-06-23",{"date":87,"type":20},"2026-12-31",{"name":66,"class":67},13,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":102,"conditions":103,"keywords":106,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":128},"100637706","phase-1-dual-targeting-car-nk-cells-in-biomarker-selected-advanced-colorectal-cancer-100637706","NCT07589517","Dual-Targeting CAR-NK Cells in Biomarker-Selected Advanced Colorectal Cancer","A Phase 1\u002F2, Biomarker-Assigned, Open-Label Dose Escalation and Expansion Study of Allogeneic Dual-Target CAR-NK Cells Targeting CEA (CEACAM5) and\u002For GUCY2C (GCC) With an Exploratory HER2\u002FERBB2-Positive Cohort in Subjects With Advanced or Metastatic Colorectal Cancer","DUO-CRC-NK-111","Inclusion Criteria:\n\n* Histologically confirmed colorectal adenocarcinoma that is unresectable or metastatic and has progressed after, is intolerant to, or is ineligible for standard therapies.\n* Measurable disease per RECIST v1.1 (unless in minimal residual disease (MRD) or post-resection cohorts if a future amendment is planned).\n* Tumor antigen co-expression meeting central lab thresholds for one of the following pairs: CEA+GUCY2C, CEA+HER2, or GUCY2C+HER2.\n* ECOG performance status 0-1.\n* Adequate organ function (hematologic, renal, hepatic, and cardiac) as defined in protocol.\n* Recovered to Grade ≤1 from prior therapy-related toxicities (except stable Grade 2 neuropathy or alopecia).\n* Life expectancy ≥ 12 weeks.\n* Willingness to use effective contraception during study and for a protocol-defined period after cell infusion.\n\nExclusion Criteria:\n\n* Active, uncontrolled infection (including uncontrolled HBV\u002FHCV) or known uncontrolled HIV infection.\n* Active CNS metastases that are symptomatic or require escalating steroids. (Stable treated CNS disease may be allowed per protocol.)\n* Prior gene-modified cellular therapy (CAR-T\u002FCAR-NK\u002FTCR-T) within 6 months, or any prior therapy that in the investigator's judgment increases risk of severe toxicity.\n* Clinically significant autoimmune disease requiring systemic immunosuppression within the past 6 months.\n* Concurrent anti-cancer therapy (other than protocol-permitted bridging) during the DLT window.\n* Pregnant or breastfeeding.\n* Significant cardiovascular disease (e.g., recent MI, uncontrolled arrhythmia), uncontrolled pulmonary disease, or other severe comorbidity that would increase risk.\n* Known hypersensitivity to study chemotherapy components (fludarabine\u002Fcyclophosphamide) or required supportive medications.\n* Any condition that, in the investigator's opinion, would interfere with study participation, safety monitoring, or interpretation of results.","75 Years",{"count":100,"type":20},48,[51,52],"This Phase 1\u002F2 study evaluates the safety, tolerability, and preliminary anti-tumor activity of an allogeneic dual-target chimeric antigen receptor natural killer (CAR-NK) cell product in adults with advanced or metastatic colorectal cancer (CRC). Participants are assigned to one of three dual-target arms based on tumor antigen co-expression: (1) CEA+GUCY2C, (2) CEA+HER2, or (3) GUCY2C+HER2. Following dose escalation, the most suitable target pair (based on safety, feasibility, and early efficacy\u002Fbiomarker signals) will be selected for dose expansion.",[104,26,105],"Colorectal Cancer","Unresectable Colorectal Cancer",[107,108,109,110,111,112,113,114,115,116,117],"CAR-NK","Dual-target CAR","CEACAM5","CEA","GUCY2C","GCC","HER2","ERBB2","Solid tumor immunotherapy","Allogeneic NK cells","Adoptive cell therapy","2026-05-10",{"date":120,"type":32},"2026-05-15",{"date":122,"type":32},"2026-02-02",{"date":124,"type":20},"2028-03-17",{"name":126,"class":127},"Beijing Biotech","INDUSTRY",1,{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":21,"phases":138,"briefSummary":139,"conditions":140,"keywords":144,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":5},"100617452","phase-1-a-study-to-learn-about-the-study-medicine-called-pf-08032562-in-people-with-advanced-or-metastatic-solid-tumors-100617452","NCT07318805","A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors","A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-08032562 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS","Inclusion Criteria:\n\n* 18 years of age or older\n* Advanced or metastatic cancer of the breast or colon Part 1A: metastatic or advanced breast cancer or colorectal cancer for which no standard therapy is available Part 1B: metastatic or advanced breast cancer with disease progression after at least 1 line of treatment with an endocrine therapy and CDK4\u002F6 inhibitor in the advanced or metastatic setting Part 1C: metastatic or advanced colorectal cancer with at least having received chemotherapy and\u002For targeted therapy if appropriate Part 1D: metastatic or advanced colorectal cancer without any prior chemotherapy for advanced or metastatic disease Part 2A: metastatic or advanced breast cancer with disease progression after at least 1 prior line of CDK4\u002F6 inhibitor and at least 1 prior line of endocrine therapy Part 2B: metastatic or advanced colorectal cancer with at least having received chemotherapy and\u002For targeted therapy if appropriate Part 2C: metastatic or advanced colorectal cancer without any prior chemotherapy for advanced or metastatic disease\n* Measurable disease\n* ECOG performance status 0 or 1\n\nExclusion Criteria:\n\n* Active malignancy within 3 years prior to enrollment\n* Known symptomatic brain metastases requiring steroids\n* Advanced\u002Fmetastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term\n* Prior irradiation to \\>25% of the bone marrow\n* Hypertension that cannot be controlled by optimal medical therapy\n* Renal impairment\n* Hepatic dysfunction\n* Cardiac abnormalities\n* Active bleeding disorder\n* Active or history of clinically significant GI disease\n* Other unacceptable abnormalities as defined by protocol",{"count":137,"type":20},260,[51],"The purpose of this study is to learn about the safety and effects of the study medicine when given alone or together with other anti-cancer therapies. Anti-cancer therapy is a type of treatment to stop the growth of cancer. This study also aims to find the best amount of study medication.\n\nThis study is seeking participants that have advanced or metastatic breast cancer (BC), or advanced or metastatic colorectal cancer (CRC).\n\nAll participants in this study will take the study medication (PF-08032562) as pill by mouth. This will be repeated for 28-day cycles.\n\nDepending on which part of the study participants are enrolled into, they will receive the study medication PF-08032562 alone or in combination with other anti-cancer medications. The study medication (PF-08032562) will be taken by mouth (PO) in combination with other anti-cancer medications given in the study clinic by intramuscular (IM) injection into the muscle or intravenous (IV) infusion that is directly injected into the veins at different times (depending on the treatment) during the 28-day cycle. The study may also test different schedules.",[141,142,104,26,143],"Advanced Breast Cancer","Metastatic Breast Cancer (HR+\u002F HER2-)","Triple Negative Breast Cancer",[145,146,147,143,148],"Carcinoma, Breast","Estrogen Receptor Positive Breast Cancer","HER2- Breast Cancer","Colon Cancer","2026-05-05",{"date":151,"type":32},"2026-05-08",{"date":153,"type":32},"2025-12-23",{"date":155,"type":20},"2030-04-14",{"name":157,"class":127},"Pfizer",{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":21,"phases":167,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":128},"100401729","phase-1-trifluridinetipiracil-and-talazoparib-for-the-treatment-of-patients-with-locally-advanced-or-metastatic-colorectal-or-gastroesophageal-cancer-100401729","NCT04511039","Trifluridine\u002FTipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer","A Phase I Study of Trifluridine\u002F Tipiracil Plus the Poly (ADP) Ribose Polymerase Inhibitor Talazoparib in Advanced Cancers","Inclusion Criteria:\n\n* Histologically or cytologically confirmed CRC or EGC adenocarcinoma that is locally advanced or metastatic (Cohort A); histologically or cytologically confirmed p53mt\u002FRASonc (Cohort B1) or p53mt\u002FRASwt CRC (Cohort B2) that is locally advanced or metastatic. Patients with adenocarcinoma histology only are allowed to participate.\n* Has received at least one prior line of therapy with progression or intolerance\n* Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Life expectancy \\>= 3 months by investigator assessment\n* Hemoglobin \\>= 9 g\u002FdL\n* Absolute neutrophil count \\>= 1500\u002Fmm\\^3\n* Platelet count \\>= 100,000\u002Fmm\\^3 without transfusion or growth factor support\n* Creatinine \\\u003C 1.5 upper limit of normal (ULN) or creatinine clearance \\> 60 mL\u002Fmin\n* Total bilirubin \\\u003C 1.5 x ULN\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) =\\\u003C 2.5 x ULN or \\\u003C x 5 ULN in the presence of liver metastasis\n* Albumin \\> 3 g\u002FdL\n* Ability to swallow oral medications\n* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Systemic antineoplastic therapy within 2 weeks prior to day -14 (Dose Escalation, Cohort A) or Cycle 1 day 1 (Dose Expansion, Cohorts B1 and B2) or within the past 6 weeks if this treatment is mitomycin C or nitrosourea\n* Radiotherapy within the past 2 weeks excluding palliative radiotherapy to painful bone lesions\n* Prior treatment with PARP inhibitor, FUDR or FTD\u002FTPI\n* Any condition that in the investigator's opinion can limit absorption of FTD\u002FTPI or talazoparib from the gastrointestinal (GI) tract\n* Gastrointestinal obstruction (without diversion) or perforation within 4 weeks from initiation of day -14 (Dose Escalation, Cohort A) or Cycle 1 Day 1 (Dose Expansion, Cohorts B1 and B2.\n* Refractory ascites (requiring weekly or more frequent paracentesis or permanent indwelling peritoneal catheter)\n* Untreated central nervous system (CNS) disease. Patients with leptomeningeal disease are ineligible but patients with treated, stable CNS metastasis for at least 4 weeks are allowed to participate\n* Significant cardiac disease defined as congestive heart failure stage III or IV (New York Heart Association \\[NYHA\\]), acute coronary event, cerebrovascular event, peripheral arterial embolic event, venous thromboembolic event (pulmonary embolism or lower extremity deep vein thrombosis), or ventricular arrhythmia within the past 3 months\n* Other malignancy requiring active therapy\n* Presence of toxicities from prior therapy of grade 2 or higher\n* Active infection requiring antibiotic therapy\n* Known human immunodeficiency virus (HIV) or hepatitis B infection or untreated hepatitis C infection. Patients with treated hepatitis C infection and undetectable viral load are allowed to participate\n* Any history of myelodysplastic syndrome, acute leukemia, or bone marrow transplant\n* Pregnant or nursing female participants\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug",{"count":166,"type":20},45,[51],"This phase I trial investigates the side effects and best dose of talazoparib when given together with trifluridine\u002Ftipiracil for the treatment of patients with colorectal or gastroesophageal cancer that has spread to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic). Drugs used in the chemotherapy, such as trifluridine\u002Ftipiracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Talazoparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving talazoparib with trifluridine\u002F tipiracil may inhibit certain enzymes in the cells that are responsible for tumor cell growth.",[170,171,172,173,174,175,176,26,177,178,179,180,181,182,183,184,185,186,187,188,189,56,190,191,192,27,193,194,195],"Advanced Malignant Solid Neoplasm","Clinical Stage III Gastroesophageal Junction Adenocarcinoma","Clinical Stage IV Gastroesophageal Junction Adenocarcinoma","Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma","Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma A","Locally Advanced Colorectal Carcinoma","Locally Advanced Gastroesophageal Junction Adenocarcinoma","Metastatic Gastroesophageal Junction Adenocarcinoma","Pathologic Stage III Gastroesophageal Junction Adenocarcinoma","Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma","Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma","Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma","Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma","Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma","Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8","Stage IIIA Colorectal Cancer AJCC v8","Stage IIIB Colorectal Cancer AJCC v8","Stage IIIC Colorectal Cancer AJCC v8","Stage IVA Colorectal Cancer AJCC v8","Stage IVB Colorectal Cancer AJCC v8","Stage IVC Colorectal Cancer AJCC v8","2026-04-30",{"date":198,"type":32},"2026-05-04",{"date":200,"type":32},"2021-06-08",{"date":202,"type":20},"2029-04-01",{"name":204,"class":39},"Roswell Park Cancer Institute",{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":21,"phases":214,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":226},"100541979","phase-1-botensilimab-plus-balstilimab-and-fasting-mimicking-diet-plus-vitamin-c-for-patients-with-kras-mutant-metastatic-colorectal-cancer-100541979","NCT06336902","Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer","A Phase Ib Study of Botensilimab Plus Balstilimab and Fasting-Mimicking Diet (FMD) Plus Vitamin C in Patients With KRAS-Mutant Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed microsatellite stable (MSS) metastatic colorectal adenocarcinoma with any KRAS mutation (as determined by a Clinical Laboratory Improvement Act \\[CLIA\\]-certified lab), including metastases to liver, lung, etc.\n* Disease progression, intolerance or contraindication to a fluoropyrimidine, oxaliplatin, irinotecan\n* ≥ 18 years of age\n* Performance status Eastern Cooperative Oncology Group (ECOG) 0-1\n* Estimated life expectancy ≥ 3 months\n* Body mass index (BMI) ≥ 18.5\n* Absolute neutrophil count ≥ 1,500\u002FmcL\n* Hemoglobin ≥ 8.0 g\u002FdL\n* Platelets ≥ 75,000\u002FmcL\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (for patients with Gilbert syndrome ≤ 3.0 x ULN)\n* Aspartate aminotransferase (AST) \u002F alanine aminotransferase (ALT) ≤ 3 x ULN\n* Creatinine ≤ 1.5 x ULN\n* Measurable disease as defined by RECIST 1.1\n* No history of prior or current malignancy that requires active treatment\n* Female patients of childbearing potential must be willing to use highly effective contraceptive measures starting with the Screening visit through 90 days after last dose of study treatment.\n\nNote: Abstinence is acceptable if this is the established and preferred contraception for the patient\n\n* Female patients of childbearing potential must have a negative serum pregnancy test at screening (within 72 hours of first dose of study medication). Non-childbearing potential is defined as 1 of the following:\n\n  * ≥ 45 years of age and has not had menses for \\> 1 year\n  * Amenorrheic for \\> 2 years without a hysterectomy and\u002For oophorectomy and follicle stimulating hormone value in the postmenopausal range upon pretrial (screening) evaluation\n  * Status is post-hysterectomy, -oophorectomy, or -tubal ligation\n* Male patients with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the trial starting with the Screening visit through 90 days after the last dose of study treatment is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.\n\nNote: Abstinence is acceptable if this is the established and preferred contraception for the patient\n\nExclusion Criteria:\n\n* Patients with a current diagnosis of diabetes mellitus are not eligible for this study.\n\nNote: Patients with pre-diabetes or previous diabetes or glucose intolerance and who are currently not taking any diabetes medications are eligible\n\n* Patients taking medications that cannot be safely stopped during the fasting periods or which may not be safely taken without food are not eligible for this study\n* Received prior systemic cytotoxic chemotherapy, biological therapy, radiotherapy, or major surgery within 3 weeks prior to first dose of study drug. A 1-week washout is permitted for palliative radiation to non-central nervous system (CNS) disease, with approval from the principal investigator\n* History of syncope with caloric restriction or another medical comorbidity which would make fasting potentially dangerous\n* Current use of oral vitamin C supplements\n* Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 3 weeks of first dose of current study drug\n* Expected to require any other form of systemic or localized antineoplastic therapy while on trial (including maintenance therapy with another agent, radiation therapy, and\u002For surgical resection)\n* History of anti-PD1 or anti-CTLA4 therapy\n* Unresolved toxicity ≥ CTCAE grade 2 except for neuropathy, alopecia\n* Untreated brain or leptomeningeal metastases or previously treated CNS metastases with any of the following: residual neurologic deficit; history of seizures; ongoing requirement of steroids, exceeding prednisone 10 mg daily dose\n* Patients who have uncontrolled or severe hyponatremia, hypernatremia, syndrome of inappropriate antidiuretic hormone secretion (SIADH), hypokalemia, hyperkalemia, hypomagnesemia, or hypermagnesemia\n* Patients who have glucose-6-phosphate dehydrogenase (G6PD) deficiency, hereditary spherocytosis, or other conditions predisposing patient to hemolysis\n* Patients who have a history of oxalate renal calculi\n* Major surgery within 4 weeks of first dose of immunotherapy\n* Known severe (grade ≥ 3) hypersensitivity reactions to fully human monoclonal antibodies, antibody, or severe reaction to immuno-oncology agents, such as colitis or pneumonitis requiring treatment with steroids; or has a history of interstitial lung disease, any history of anaphylaxis, or uncontrolled asthma\n* Evidence of bleeding diathesis or clinically significant coagulopathy\n* Receiving systemic corticosteroid therapy 1 week prior to the first dose of study drug or receiving any other form of systemic immunosuppressive medication.\n\nNote: Corticosteroid use as a premedication for IV contrast allergies\u002Freactions is allowed. Patients who are receiving daily corticosteroid replacement therapy are also an exception to this rule. Daily prednisone at doses of ≤ 10 mg or equivalent hydrocortisone dose are examples of permitted replacement therapy. Use of inhaled or topical corticosteroid is permitted\n\n* Active or history of autoimmune disease that requires systemic treatment within 2 years of the start of study drug (i.e., use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).\n\nNote: Patients with autoimmune conditions requiring hormone replacement therapy or topical treatments are eligible\n\n* Has had an allogeneic tissue\u002Fsolid organ transplant, except for corneal transplants\n* Legally incapacitated or has limited legal capacity\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, active coronary artery disease, myocardial infarction or cerebrovascular accident within 6 months prior to study entry, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements",{"count":213,"type":20},15,[51],"This phase Ib trial tests the safety, side effects, and effectiveness of botensilimab, and balstilimab in combination with a fasting mimicking diet and high dose vitamin C in treating patients with KRAS-mutant metastatic colorectal cancer. Botensilimab and balstilimab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. KRAS is protein found on some tumor cells that is involved in the growth of tumor cells. KRAS mutant cells have been found to be more sensitive to vitamin C induced growth suppression in the presence of low-sugar (glucose). A fasting mimicking diet, a plant-based, calorie reduced, low-sugar diet alternating with refeeding periods, may positively change the way the body responds to cancer treatment. Vitamin C is a nutrient that the body needs in small amounts to function and stay healthy. It is an antioxidant that that can help prevent cell damage and may block growth and spread of tumor cells. Botensilimab and balstilimab in combination with a fasting mimicking diet and high dose vitamin C may be safe, tolerable and effective in treating patients with KRAS-mutant metastatic colorectal cancer.",[26,27],"2026-03-13",{"date":219,"type":32},"2026-03-17",{"date":221,"type":32},"2025-01-15",{"date":223,"type":20},"2028-01-15",{"name":225,"class":39},"University of Southern California",3,{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":16,"minAge":234,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":21,"phases":237,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":5},"100603006","phase-2-amplitude-modulated-radiofrequency-electromagnetic-fields-am-rf-emf-in-combination-with-fruquintinib-in-refractory-metastatic-colorectal-cancer-100603006","NCT07130903","Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF) in Combination With Fruquintinib in Refractory Metastatic Colorectal Cancer","A Phase 2 Study of Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF) in Combination With Fruquintinib in Refractory Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* Participant must have histologically or cytologically confirmed metastatic colorectal adenocarcinoma. There must be previous documentation of RAS (Rat sarcoma mutation), BRAF (B-Raf proto-oncogene, Serine\u002Fthreonine kinase), MSI\u002FMMR (microsatellite instability, mismatch repair) , and HER2 (Human epidermal growth factor receptor 2) status.\n* Participant must have progressed on or been intolerant to the following previous treatments (if not contraindicated):\n\n  * Fluoropyrimidine-, oxaliplatin-, or irinotecan-based chemotherapy\n  * Anti-VEGF (vascular endothelial growth factor) biological therapy, such as bevacizumab, aflibercept, or ramucirumab\n  * If RAS is wild type, an anti-EGFR (epidermal growth factor receptor) therapy like cetuximab or panitumumab\n* Participant must have evaluable disease as defined by the investigator using CT (computed tomography), MRI (magnetic resonance imaging), or PET (positron emission tomograph) scan.\n* Participant must have a body weight ≥ 40 kg.\n* Participant must be aged 22 years or older.\n* Participant must be able to understand a written informed consent document and be willing to sign it.\n* Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Participant must have adequate organ and marrow function within 14 days prior to the initiation of treatment as described below:\n* Participant should have an expected lifespan of \\>12 weeks as determined by the investigator.\n* Fruquintinib is suspected to cause loss of human pregnancy and impaired development of the embryo or fetus. Therefore, women of child-bearing potential must agree to avoid becoming pregnant and male participants should avoid impregnating a female partner starting at initiation of treatment up until at least 14 days after the last fruquintinib dose.\n\nExclusion Criteria:\n\n* Participants with uncontrolled hypertension per investigator discretion.\n* Participants with a history or presence of gastric\u002Fduodenal ulcer or ulcerative colitis, hemorrhage of an unresected gastrointestinal tumor, perforation, fistulas, or any other condition that could, in the investigator's judgment, result in gastrointestinal hemorrhage or perforation.\n* Participants with a history or presence of hemorrhage from any other site (i.e., lower GI bleed, hemoptysis or hematemesis) within two months prior to screening.\n* Participants with a history of a thromboembolic event, including deep vein thrombosis (DVT), pulmonary embolism (PE), or arterial embolism within three months prior to screening unless they are on a stable dose of anticoagulant and no further evidence of active thromboses are seen on CT scan or venous Doppler imaging. Participants with saddle (massive) pulmonary embolism that require thrombectomy\u002Fthrombolysis within 12 months of screening are excluded from the trial.\n* Participants with a history of stroke and\u002For transient ischemic attack within 12 months prior to screening.\n* Participants with clinically significant cardiovascular disease, including but not limited to acute myocardial infarction or coronary artery bypass surgery within six months prior to enrollment, severe or unstable angina pectoris, New York Heart Association Class III\u002FIV congestive heart failure, ventricular arrhythmias requiring treatment, or previous left ventricular ejection fraction (LVEF) \\\u003C 50% by echocardiogram.\n* Participants with corrected QT interval using the Fridericia method (QTcF) \\> 480 msec or any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in a first-degree relative.\n* Participants taking concomitant medications with a known risk of causing QT prolongation and\u002For torsades de pointes. (Source list is continuously updated online at www.crediblemeds.org.)\n* Participants taking systemic anti-neoplastic therapies four weeks prior to the first dose of study drug, including chemotherapy, biotherapy, or immunotherapy. Palliative radiation is allowed if it does not cover all evaluable disease.\n* Participants taking systemic small molecule targeted therapies (e.g., tyrosine kinase inhibitors) within five half-lives or four weeks, whichever is shorter, prior to the first dose of study drug.\n* Participants who have undergone major surgery within 30 days prior to the first dose of study drug or if they still have unhealed surgical incision from previous surgery.\n* Participants with any unresolved toxicities from a previous antitumor treatment greater than NCI CTCAE v5.0 grade 2.\n* Participants that have current drug or alcohol abuse.\n* Participants with known human immunodeficiency virus (HIV) infection are not eligible if their viral load and\u002For CD4 (cluster of differentiation 4) count are considered poorly controlled with anti-HIV therapy.\n* Participants with a known history of active viral hepatitis. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Participants that test positive for hepatitis C virus (HCV) but are currently being treated are eligible if they have an undetectable HCV viral load.\n* Participants with clinically uncontrolled active infections requiring intravenous antibiotics.\n* Participants with tumor invasion of a large vascular structure (e.g., pulmonary artery, superior or inferior vena cava).\n* Participants with brain metastases and\u002For spinal cord compression untreated with surgery and\u002For radiotherapy and without clinical imaging evidence of stable disease for 14 days or longer.\n* Participants with known active secondary malignancy, unless, in the opinion of the investigator, it is unlikely to interfere with the safety and efficacy of the endpoints.\n* Participants that are unable to take medication orally including those with dysphagia or an active gastric ulcer resulting from previous surgery (e.g., gastric bypass) or severe gastrointestinal disease, or any other condition that the investigator believes may affect absorption of fruquintinib.\n* Participants with metabolic disorder that the investigator suspects may prohibit fruquintinib action, affect interpretation of study results, or put the participant at undue risk of harm based on the investigator's assessment.\n* Participants that have received prior fruquintinib treatment.\n* Participants with a known hypersensitivity to fruquintinib or any of its inactive ingredients including the azo dyes tartrazine, FD\\&C yellow 5, and sunset yellow FCF.\n* Participants taking strong inducers or inhibitors of CYP3A4 within five half-lives or four weeks, whichever is longer, before the first dose of study drug. Refer to Appendix 2 for a comprehensive list of excluded medications related to CYP3A4.\n* Participants that are taking any other investigational drugs.\n* Participants with active oral mucosal inflammation, ulceration, or other pathology that could interfere with the use of TheraBionic P1 device (for example: mucositis, thrush, bleeding mucosal lesions, oral herpes, aphthous stomatitis, mouth ulcers, chancre sores, gingivostomatitis, herpangina, aphthae).\n* Participants receiving calcium channel blockers and any agent blocking L-type or T-type voltage gated calcium channels (for example: amlodipine, nifedipine, ethosuximide, ascorbic acid\u002Fvitamin C, etc.) unless these drugs are discontinued at least 7 days prior to starting TheraBionic P1 device treatment. Participant must agree to abstain from using calcium channel blockers for the duration of treatment on study. Refer to Appendix 3 for a comprehensive list of excluded medications related to calcium channels.\n* Participants that are pregnant or breastfeeding are ineligible for this study. If a breastfeeding participant would like to be part of this study, breastfeeding must be discontinued.\n* Participants who have received a live vaccine ≤ 28 days before the first dose of fruquintinib. (Seasonal vaccines for influenza are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed.)\n* Participants that do not agree to be followed according to the study protocol or have cognitive or physical inability to use the device.","22 Years",{"count":236,"type":20},102,[52],"The goal of this clinical trial is to learn if adding amplitude-modulated radiofrequency electromagnetic fields (AM RF EMF) to Fruquintinib in metastatic colorectal cancer that has not responded to other standard treatment is:\n\n* Effective in improving survival\n* safe and tolerable",[26],"2025-11-05",{"date":242,"type":32},"2025-11-10",{"date":244,"type":32},"2025-09-10",{"date":246,"type":20},"2030-04-17",{"name":248,"class":39},"Barbara Ann Karmanos Cancer Institute",{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":256,"enrollmentInfo":257,"targetDuration":4,"studyType":21,"phases":259,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":264,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":128},"100531121","phase-1-clinical-study-of-short-course-radiotherapy-followed-by-fruquintinib-plus-sintilimab-vs-bevacizumab-plus-capecitabine-as-first-line-treatment-in-advanced-mcrc-100531121","NCT06195670","Clinical Study of Short-course Radiotherapy Followed by Fruquintinib Plus Sintilimab vs Bevacizumab Plus Capecitabine as First Line Treatment in Advanced mCRC","An Open-label, Multi-centered, Two-stage Clinical Study of Short-course Radiotherapy Followed by Fruquintinib Plus Sintilimab vs Bevacizumab Plus Capecitabine in the First Line Treatment of Advanced mCRC Patients Unfit for Intense Therapy","Inclusion Criteria:\n\n* Have signed an informed consent;\n* 18 to 85 years old (including 18 and 85 years old);\n* Histopathologically confirmed unresectable advanced metastatic colorectal adenocarcinoma;\n* Have not received anti-tumor treatment for metastatic disease;\n* Inability to tolerate intensive treatment regimens based on oxaliplatin or irinotecan as determined by researchers;\n* At least one measurable lesion;\n* Expected life expectancy ≥ 12 weeks;\n* The function of important organs within the 14 days prior to enrollment meets the following requirements (no blood components or cell growth factors are allowed to be used within the 14 days prior to enrollment):\n* Neutrophil absolute count ≥ 1.5 × 10\\^9\u002FL;\n* Platelets ≥ 80 × 10\\^9\u002FL;\n* Hemoglobin ≥ 8g\u002FdL;\n* Total bilirubin\\\u003C1.5 times ULN;\n* ALT and AST\\\u003C2.5 times ULN (liver metastasis patients\\\u003C5 times ULN);\n* Serum creatinine ≤ 1.5 times ULN;\n* Endogenous creatinine clearance rate\\>50ml\u002Fmin;\n* International standardized ratio (INR) of coagulation function ≤ 1.5 × ULN, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN\n* Women of childbearing age or men whose partners have a desire to conceive should take effective contraceptive measures.\n\nExclusion Criteria:\n\n* Currently has a disease or condition that affects drug absorption, or the patient is unable to take oral drugs;\n* Currently has digestive tract diseases such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresectable tumors, or other conditions determined by the researcher that may cause gastrointestinal bleeding or perforation;\n* History of serious cardiovascular and cerebrovascular diseases;\n* Other malignant tumors within the past 5 years, excluding skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ;\n* Clinically uncontrolled active infection, such as acute pneumonia, active hepatitis B or hepatitis C (hepatitis B virus DNA ≥ 1 × 104 copies\u002FmL or\\>2000 IU\u002Fml);\n* Currently has central nervous system (CNS) metastasis or has a history of unstable or clinically symptomatic brain metastasis;\n* Pregnant (positive pregnancy test before medication) or breastfeeding women;\n* Urine protein ≥ 2+, or 24-hour urine protein \\>1.0g;\n* Histologically confirmed MSI-H\u002FdMMR tumors;\n* Patients deemed unsuitable by the researchers for inclusion in this study.","85 Years",{"count":258,"type":20},220,[51,52],"The aim of this study is to evaluate the efficacy and safety of short course radiotherapy followed by fruquintinib combined with Sintilimab as the first-line treatment of advanced mCRC compared to bevacizumab combined with capecitabine in patients unfit for intensive therapy.",[262,263,26],"CRC","Metastatic Colorectal Cancer","NOT_YET_RECRUITING","2023-12-22",{"date":267,"type":32},"2024-01-08",{"date":269,"type":20},"2024-01",{"date":271,"type":20},"2027-01",{"name":273,"class":39},"Zhejiang Cancer Hospital"]