[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Oncomatryx Biopharma S.L.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":62},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"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":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100621932","phase-1-clinical-trial-of-omtx705-in-combination-with-gemcitabinenab-paclitaxel-and-tislelizumab-in-patients-with-advancedmetastatic-pancreatic-adenocarcinoma-100621932",false,"NCT07377045","Clinical Trial of OMTX705 in Combination With Gemcitabine\u002FNab-Paclitaxel and Tislelizumab in Patients With Advanced\u002FMetastatic Pancreatic Adenocarcinoma","Phase 1b Dose Escalation Trial of OMTX705, an Anti-Fibroblast Activation Protein Antibody-Drug Conjugate, in Combination With Gemcitabine\u002FNab-Paclitaxel and Tislelizumab in Patients With Advanced\u002FMetastatic Pancreatic Adenocarcinoma","Inclusion Criteria:\n\n1. Capable of giving signed informed consent.\n2. Male and female participant aged 18 years and older.\n3. Participants must have histologically or cytologically confirmed PDAC: a) Metastatic PDAC who have not received therapy or received 1 prior line of systemic cytotoxic therapy (Part 1 and Part 2) and if trial treatment is given in the second line setting; b) Non-resectable locoregional PDAC who have not received therapy or received 1 prior line of systemic cytotoxic therapy (Part 1 only); c) A previous treatment with a targeted agent (for example KRAS inhibitor in the context of a clinical trial) without chemotherapy not counted as previous line of therapy. This situation should be discussed with the medical monitor.\n4. Participants should have documented disease progression if previously locally advanced disease or be in 2nd line for stage IV or, in the opinion of the investigator, despite of lack of documented PD per image, require a change in the therapy.\n5. Participants should be considered in general eligible for standard GA, for first or second line for metastatic disease (Part 1 and 2) or as palliative therapy for non-resectable locoregional cancer (Part 1 only). Patients who received polychemotherapy (FOLFIRINOX or similar) as neoadjuvant\u002Fadjuvant treatment and recur locally or distant \\\u003C6 months after the completion of systemic therapy, will be classified as second line.\n6. Measurable disease by RECIST v1.1 on CT PET\u002FCT or magnetic resonance imaging (MRI) scan.\n7. Eastern Cooperative Group Performance (ECOG) performance status 0-1.\n8. Adequate bone marrow, hepatic and renal function: a) Total bilirubin ≤1.5 times upper limit of normal (ULN) or total bilirubin n \\\u003C3.0 × ULN with direct bilirubin within normal range in participants with documented Gilbert's syndrome; b) AST and ALT ≤3 times ULN, (if liver metastases are present, then ≤5 times ULN is allowed); c) Serum creatinine ≤1.5 x ULN or creatinine clearance ≥40 mL\u002Fmin (measured or calculated using the Cockroft-Gault formula); d) Hemoglobin ≥9.0 g\u002FdL (whole or partial blood transfusions not allowed in the two previous weeks); e) ANC ≥1.5 x 109\u002FL (growth factors like granulocyte-colony stimulating factor are not allowed in the two previous weeks); f) Platelet count ≥100 x 109\u002FL (platelet in the two previous weeks transfusions not allowed).\n9. Women of childbearing potential (WOCBP) and men with sexual partners who are WOCBP must be willing to adhere to highly effective contraceptive requirements and must agree to avoid impregnating a partner or becoming pregnant, respectively, during the study, and for at least 90 days after the last dose of any IMP. Men with sexual partners who are WOCBP should adhere to contraception requirements for 180 days after the last dose of any IMP.\n10. Suitable venous access for safe drug administration and the study-required drug concentration and pharmacodynamics sampling.\n11. A valid archival tumor sample.\n12. Pretreatment fresh biopsy is optional in Part 1 dose escalation. In Part 2, a fresh pretreatment biopsy and on-treatment is required unless biopsy is associated with significant risk and per discussion with the sponsor medical monitor (or designee).\n\nExclusion Criteria:\n\n1. Prior treatment with OMTX705 or nab-paclitaxel for the locally advanced (adjuvant or neoadjuvant) for metastatic disease. Previous use of gemcitabine as radiosensitizer or as part of neoadjuvant\u002Fadjuvant therapy is allowed if the treatment was completed 6 months before consent signature. Prior treatment with T-cell co-stimulating or immune checkpoint blockade therapies including anti-cytotoxic T-lymphocyte associated protein 4, anti-PD-1, and anti-PD-L1 therapeutic antibodies or any immune checkpoint inhibitor (except for participants to be enrolled in Part 1A).\n2. Treatment with systemic anticancer treatments, investigational products, or major surgery within 4 weeks before the first dose of study drug or 5 half-lives, whichever is shorter. Participants should have recovered from previous treatment toxicity to Grade 1, baseline (excluding anemia, lymphopenia, alopecia, and skin pigmentation). Participants with endocrinopathies should have the replacement treatment in stable dosing.\n3. History of uncontrolled brain metastasis. Participants with brain metastases are allowed if they are previously treated with surgery, whole-brain radiation, or stereotactic radiosurgery and have brain imaging during screening confirming that brain metastasis are stable (without evidence of progression by imaging using the identical imaging modality for each assessment, either MRI or CT and considered controlled with ≤10 mg\u002Fday prednisone equivalent at the time of receiving the first dose of OMTX705). For asymptomatic participants, screening brain imaging is not required.\n4. Participant has received extended field radiotherapy ≤4 weeks before the start of treatment (≤1 week for limited field radiation for palliation), and who has not recovered to Grade 1 or better from related side effects of such therapy (except for alopecia).\n5. Major surgical procedure or significant traumatic injury ≤21 days prior to ICF signature.\n6. Cardiac arrhythmias requiring anti-arrhythmic therapy. Note: pacemakers, beta blockers, or digoxin are permitted.\n7. Active infection requiring parenteral or oral antibiotics. Antibiotics given for prophylaxis are allowed. They are also allowed for minor localized infections like cystitis, amygdalates or localized skin infections.\n8. Evidence of serious uncontrolled medical disorder that, in the opinion of the investigator or medical monitor, makes it unwise for the participant to participate in the study or that might jeopardize compliance with the protocol.\n9. Drainage of ascitic or pleural fluid two or more times in the four weeks prior to the first dose of study drug or permanent drain in place (e.g., PleurX®) for ascites or pleural effusion symptom management.\n10. Placement of a biliary stent, endoscopic retrograde cholangiopancreatography (ERCP) or biliary catheterization (internal or percutaneous) procedure \\\u003C7 days before the first dose.\n11. Psychiatric illness\u002Fsocial circumstances that would limit compliance with study requirements and substantially increase the risk of AEs or compromised ability to provide written informed consent.\n12. Previous or concurrent cancer that is distinct in primary site or histology from PDAC within 3 years prior to randomization except for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors (Ta \\[non-invasive tumor\\], Tis \\[carcinoma in situ\\] and T1 \\[tumor invades lamina propria\\]); note: all cancer treatments for cancers that were distinct in a primary site other than PDAC must be completed at least 3 years prior to signature date of the ICF.\n13. Uncontrolled or significant cardiovascular disease defined by the New York Hearth Association classification III or IV.\n14. History of cerebrovascular stroke or myocardial infarction within the previous 3 months.\n15. Grade ≥2 peripheral neuropathy.\n16. Received a live vaccine within 30 days prior to first dose of study drug.\n17. Known hepatitis B virus surface antigen seropositive or detectable hepatitis C infection viral load. Note: Participants who have positive hepatitis B surface antigen antibody can be included but must have an undetectable hepatitis B viral load. Participants receiving antiviral therapy for hepatitis B virus for any reason are excluded.\n18. Participants positive for human immunodeficiency virus (HIV) are NOT excluded from this study, but HIV-positive participants must meet the following criteria: a) have CD4+ T-cell (CD4+) counts ≥350 cells\u002FμL; b) have not had an opportunistic infection within the past 12 months. Participants on prophylactic antimicrobials can be included in the trial; c) should be on established antiretroviral therapy for at least four weeks; d) have an HIV viral load of less than 400 copies\u002FmL prior to enrollment; e) known history of any other relevant congenital or acquired immunodeficiency other than HIV infection.\n19. Known or suspected allergy to study treatment or related products, and specifically participants with a prior history of life-threatening reaction to polysorbate 20.\n20. Women who are pregnant or breastfeeding or trying to become pregnant.\n21. Male participants wishing fathering children, planning for future sperm banking, or expressing concerns about sterility.\n22. Participants requiring the concomitant administration of medications that are strong inhibitors or inducers of CYP3A4, 2D6, 1A2, 2C9, 2B6, and 2C19. In case they are taking any of these drugs, they should be stopped at least 14 days prior to first dose.\n23. Except Part1A: History of autoimmune disease requiring systemic immunosuppressive therapy (daily prednisone equivalent doses \\>10 mg\u002Fday).\n24. Except Part 1A: Participants who discontinued prior treatment with any immune checkpoint due to irAEs, irrespective of grade, recovery, or need for continued steroid therapy. Also, participants without formal contraindication due to previous irAE are not eligible if the AE has not resolved to Grade 1 or better and\u002For still requires steroids (\\>10 mg of prednisone equivalent per day) for ongoing management.\n25. Except Part 1A: participants with a history of pneumonitis\u002Finterstitial lung disease, and participants who discontinued prior immune checkpoint inhibitors due to Grade 2 myocarditis.","ALL","18 Years",{"count":19,"type":20},69,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a Phase 1b dose escalation trial of OMTX705, an anti-fibroblast activation protein (FAP) antibody-drug conjugate (ADC), in combination with gemcitabine\u002Fnab-paclitaxel and tislelizumab in patients with advanced\u002Fmetastatic pancreatic ductal adenocarcinoma (PDAC).\n\nThe trial will be conducted in two parts (Part 1 and Part 2). Both parts will enroll participants with advanced PDAC that, in general, are eligible to receive gemcitabine\u002Fnab-paclitaxel. Part 1 is intended to determine the safe recommended dose of OMTX705 in combination with gemcitabine\u002Fnab-paclitaxel (1A) and in combination with gemcitabine\u002Fnab-paclitaxel+tislelizumab (1B). Both 1A and 1B will enroll in a standard 3+3 design. Only one dose level of OMTX705 will be selected for Part 2 by a Data Safety Monitoring Board (DSMB). In Part 2, 3 parallel randomized arms will be opened simultaneously with 1:1:1 randomization (N=15 each): OMTX705+gemcitabine\u002Fnab-paclitaxel (arm 2A), OMTX705+tislelizumab+gemcitabine\u002Fnab-paclitaxel (arm 2B) and gemcitabine\u002Fnab-paclitaxel (arm 2C, reference arm).",[26],"Pancreatic Adenocarcinoma Metastatic","RECRUITING","2026-01-21",{"date":30,"type":31},"2026-01-29","ACTUAL",{"date":33,"type":31},"2025-10-28",{"date":35,"type":20},"2029-03",{"name":37,"class":38},"Oncomatryx Biopharma S.L.","INDUSTRY",7,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":61},"100481309","phase-1-efficacy-and-safety-study-of-omtx705-monotherapy-and-anti-pd-1-combined-in-subjects-with-advanced-solid-tumors-100481309","NCT05547321","Efficacy and Safety Study of OMTX705, Monotherapy and Anti-PD-1-combined, in Subjects With Advanced Solid Tumors.","Phase 1 Dose-escalation Trial of OMTX705, an Anti-fibroblast Activation Protein Antibody-drug Conjugate, as Single Agent and in Combination With Anti-PD-1 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Male and female patients aged 18 years and older.\n2. Part 1 monotherapy and combination: Patients with histologically confirmed advanced (locoregionally recurrent, not amenable to curative therapy) or metastatic solid tumors that have no standard therapeutic option with a proven clinical benefit, or are intolerant to these therapies with any of the following selected tumor histologies: PDAC, gastric cancer (including gastroesophageal junction tumors), head and neck squamous-cell carcinoma (HNSCC), esophageal cancer, NSCLC, high grade serous ovarian cancer, primary peritoneal cancer, mesothelioma, BC, CRC, and FAP positive leiomyosarcoma or other FAP-positive sarcomas (with sponsor's approval). Patients with other tumor histologies may be enrolled with explicit sponsor's approval.\n\n   Part 2:\n   * SARC1 cohort: patients with locally advanced or metastatic FAP-positive sarcomas that have no standard therapeutic option with a proven clinical benefit or are intolerant to these therapies. FAP-positive is defined as expression of FAP with an H-score ≥40 or 2+\u002F3+ in a tumor biopsy that can be either archival or fresh. FAP positivity will be considered exclusively on sarcoma cells and not in surrounding fibroblasts or other stromal cells. FAP measurement will be done in a central laboratory provided by the sponsor during the screening period (in countries where this is permitted). Alternatively, eligible patients may have had FAP quantified locally before enrolling the trial as part of the previous care of the patient. In the latter case, FAP will be re-quantified retrospectively in a central lab designated by the sponsor.\n   * PDAC\\_low and\\_high cohorts: patients with metastatic PDAC who have received at least two and no more than four previous lines of systemic treatment for metastatic disease. If the patient received neoadjuvant\u002Fadjuvant therapy and recurred \\\u003C6 months after the last dose, this line will be counted as the first line for the metastatic disease.\n   * SCHED1 cohort: patients with tumors meeting Part 1 definitions.\n   * BIOPSY cohort: preferentially patients with metastatic CRC, esophageal cancer, GEJ cancer, gastric or NSCLC that have no standard therapeutic option with a proven clinical benefit or are intolerant to these therapies and volunteer for a fresh pre-treatment biopsy during the screening procedure and on-treatment biopsy. Other tumor histologies can be included after approval from the sponsor´s medical monitor.\n3. Patients with tumors with actionable mutations should have progress to all approved and locally available targeted therapies or have them contraindicated.\n4. Measurable disease by RECIST 1.1 on computerized tomography (CT), positron emission tomography (FDG-PET) or magnetic resonance (MRI) scan. Imaging tests outside the screening period are valid if performed not more than two weeks before consent signature and otherwise fulfil protocol criteria. In sites where available, FAPI-PET can be used but always with an associated CT.\n5. Patients should have documented progression to the last line of therapy or, in the opinion of the investigator, require a change in the therapy. This latter option must be discussed and approved explicitly by the sponsor's medical monitor.\n6. ECOG performance status 0-1.\n7. Serum albumin ≥3.0 g\u002FdL.\n8. Adequate bone marrow, hepatic and renal function:\n\n   1. Total bilirubin ≤1.5 times upper limit of normal (ULN).\n   2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 times ULN, (if liver metastases are present, then ≤5 times ULN is allowed).\n   3. For Part 1 only: estimated creatinine clearance (CrCL) using the Cockcroft-Gault formula ≥60 mL\u002Fminute. Patients with calculated CrCL \\\u003C60 mL\u002Fmin can be enrolled if measured CrCL is ≥60 mL\u002Fmin.\n   4. For Part 2 only:, CrCL should be ≥30 mL\u002Fmin.\n   5. Hemoglobin ≥9 g\u002FdL (whole or partial blood transfusions not allowed in the two previous weeks before enrollment).\n   6. Absolute neutrophil count (ANC) ≥1.5 x 109\u002FL (growth factors like G-CSF are not allowed in the two previous weeks before enrollment).\n   7. Platelet count ≥75 x 109\u002FL (platelet transfusions not allowed in the two previous weeks).\n9. Women of childbearing potential (WOCBP) (as defined in Appendix 3) and men with sexual partners who are WOCBP must be willing to adhere to contraceptive requirements as detailed in the protocol (Appendix 3) from at least one month prior to study entry to at least four months after the last dose of study treatment.\n10. Suitable venous access for safe drug administration and the study-required drug concentration and PD sampling.\n11. For Part 1 only: an archival biopsy for translational research should be available. If the archival biopsy is unavailable or does not have the requirements specified in the sample management plan, it can be replaced with a fresh biopsy. If the archival biopsy is unavailable and the fresh biopsy is not feasible, the medical monitor must approve explicitly the inclusion of the patient. Patients to be enrolled in Part 1 backfilling cohorts should consent for paired screening and on-treatment biopsies.\n12. For Part 2 only (Section 6.20.2):\n\n    i.For patients with sarcoma in the cohort SARC1, an archival or fresh biopsy for FAP quantification during the screening period for eligibility is required.\n\nii.For PDAC\\_low, PDAC\\_high and BIOPSY cohorts, the patient must consent for fresh paired biopsies. NOTES: (i) In some exceptional circumstances, the medical monitor can waive the obtention of paired treatment biopsies upon request from the investigator. The rationale for the decision needs to be documented in writing. (ii) A patient receiving treatment can decline the on-treatment biopsy without providing any explanation and continue on study. If it is the investigator who decides to skip the on-treatment biopsy the rationale needs to be discussed with the medical monitor and documented in writing.\n\niii.For patients enrolled in the SCHED1 cohort, paired fresh biopsies are desirable but voluntary.\n\nExclusion Criteria:\n\nPatients eligible for this study must not meet any of the following criteria:\n\n1. Treatment with systemic anticancer treatments, investigational products, or major surgery within four weeks before the first dose of study drug or five half-lives, whichever is shorter. Subjects should have recovered from previous treatment toxicity to Grade 1, baseline (except alopecia). Patients with endocrinopathies should have the replacement treatment in stable dosing.\n2. History of uncontrolled brain metastasis. Subjects with brain metastases are allowed if they are previously treated with surgery, whole-brain radiation, or stereotactic radiosurgery and have new brain imaging confirming that brain metastasis are stable (without evidence of progression by imaging using the identical imaging modality for each assessment, either MRI or CT and considered controlled with \\\u003C10 mg\u002Fday of prednisone-equivalent at the time of receiving the first dose of OMTX705. For asymptomatic subjects, screening brain imaging is not required.\n3. Patient has received extended field radiotherapy ≤four weeks before the start of treatment (≤one week for limited field radiation for palliation), and who has not recovered to Grade 1 or better from related side effects of such therapy (except for alopecia).\n4. Active infection requiring parenteral or oral antibiotics. Antibiotics given for prophylaxis are allowed. They are also allowed for minor localized infections like cystitis, tonsilitis or localized skin infections.\n5. Evidence of a serious uncontrolled medical disorder that, in the opinion of the investigator or medical monitor, makes it unwise for the subject to participate in the study or that might jeopardize compliance with the protocol.\n6. Drainage of ascitic or pleural fluid two or more times in the 4 weeks prior to the first dose of study drug or permanent drain in place (e.g, PleurX®) for ascites or pleural effusion symptom management.\n7. Psychiatric illness\u002Fsocial circumstances that would limit compliance with study requirements and substantially increase the risk of AEs or compromised ability to provide written informed consent.\n8. Clinical evidence of an active second invasive malignancy with the exception of stable prostate cancer on watchful waiting, in situ cervical cancer, breast ductal carcinoma in situ or localized non-melanoma skin cancers.\n9. Uncontrolled or significant cardiovascular disease defined by the New York Hearth Association (NYHA) classification III or IV.\n10. History of cerebrovascular stroke or myocardial infarction within the previous three months.\n11. Grade ≥2 peripheral neuropathy.\n12. Baseline QTc (using the Fridericia correction calculation) \\> 470 msec (unless pacemaker in place, only for patients in Part 2)\n13. Combination with pembrolizumab\u002Ftislelizumab: history of autoimmune disease requiring systemic immunosuppressive therapy (daily prednisone equivalent doses \\>10 mg\u002Fday).\n14. Combination with pembrolizumab\u002Ftislelizumab: patients who discontinued prior treatment with any immune checkpoint due to irAEs, irrespective of grade, recovery, or need for continued steroid therapy. Also, subjects without formal contraindication due to previous irAE with any immune checkpoint inhibitor (approved or investigational) are not eligible if the AE has not resolved to Grade 1 or better and\u002For still requires steroids (\\>10 mg of prednisone equivalent per day) for ongoing management.\n15. Combination with pembrolizumab\u002Ftislelizumab: patients with a history of pneumonitis\u002Finterstitial lung disease, patients who received live vaccines within 30 days of enrollment, and patients who discontinued prior immune checkpoint inhibitors due to Grade 2 myocarditis are excluded from enrollment into immune checkpoint inhibitor-containing cohorts.\n16. Known hepatitis B virus surface antigen seropositive or detectable hepatitis C infection viral load. Note: Subjects who have positive hepatitis B surface antigen antibody can be included but must have an undetectable hepatitis B viral load.\n17. Patients positive for human immunodeficiency virus (HIV) are NOT excluded from this study, but HIV-positive patients must meet the following criteria:\n\n    1. have CD4+ T-cell (CD4+) counts ≥350 cells\u002FμL.\n    2. have not had an opportunistic infection within the past 12 months. Patients on prophylactic antimicrobials can be included in the trial.\n    3. should be on established antiretroviral therapy for at least four weeks.\n    4. have an HIV viral load of less than 400 copies\u002FmL prior to enrollment.\n    5. known history of any other relevant congenital or acquired immunodeficiency other than HIV infection.\n18. Known or suspected allergy to study treatment or related products, and specifically patients with a prior history of life-threatening reaction to polysorbate 20.\n19. Women who are pregnant or breastfeeding or trying to become pregnant.\n20. Male patients wishing fathering children, planning for future sperm banking, or expressing concerns about sterility.\n21. Patients requiring the concomitant administration of medications that are strong inhibitors or inducers of CYP3A4, 2D6, 1A2, 2C9, 2B6, and 2C19. In case they are taking any of these drugs (Appendix 4), they should be stopped at least 14 days prior to first dose.\n22. For Part 1 only: Only in particular circumstances it will be possible to enroll sarcoma patients with negative FAP expression on the surface of the tumor cells (central lab assessment) or without knowing FAP expression levels before C1D1. However, these cases must be discussed and explicitly approved by the sponsor´s medical monitor.",{"count":48,"type":20},150,[23],"Open-label, two parallel arm, multicenter, Phase 1 dose-escalation study to evaluate the safety and tolerability of OMTX705, both as monotherapy or in combination with pembrolizumab (Part 1) or tislelizumab (Part 2) in the treatment of patients with advanced or metastatic cancer in whom there is no available standard therapeutic option.",[52],"Advanced Solid Tumor","2025-11-20",{"date":55,"type":31},"2025-11-25",{"date":57,"type":31},"2022-10-20",{"date":59,"type":20},"2027-12",{"name":37,"class":38},9,""]