[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Avacta Life Sciences Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":75},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100627900","phase-1-ava6103-in-subjects-with-locally-advanced-or-metastatic-selected-solid-tumors-100627900",false,"NCT07454642","AVA6103 in Subjects With Locally Advanced or Metastatic Selected Solid Tumors","A Phase 1, Open Label, Dose-Escalation and Expansion Study to Evaluate Safety, Pharmacokinetics and Initial Therapeutic Activity of AVA6103, a Novel FAP-activated Exatecan Administered Intravenously in Subjects With Locally Advanced or Metastatic Selected Solid Tumors","FOCUS-01","Inclusion Criteria:\n\n1. The subject is fully informed about the study and is willing and able to sign the informed consent form (ICF).\n2. Male or female subjects, ≥18 years of age.\n3. Subjects with the following tumors reported to be FAP positive, with histological or cytological confirmation of a locally advanced (unresectable) and\u002For metastatic progressing disease that have received all standard-of-care or Food and Drug Administration (FDA) approved treatments, or are ineligible for those treatments, or decline those treatments\n\n   1. Cervical\u002Fvulvar cancer\n   2. SCLC\n   3. Gastric\u002FGEJ cancer\n   4. PDAC\n   5. CRC\n   6. HR+ breast cancer\n4. Has a life expectancy of ≥3 months, in the opinion of the investigator.\n5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Has recovered from all acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure (must have resolved to CTCAE Grade ≤1 or returned to baseline, whichever is greater. Exceptions include alopecia and peripheral neuropathy, which can be up to CTCAE Grade 2).\n7. Has adequate hematological function (applies only to subjects not receiving therapeutic anticoagulation; subjects receiving therapeutic anticoagulation should be on a stable dose):\n\n   1. Absolute neutrophil count of ≥1.5 × 109 cells\u002FL. Subjects with documented benign ethnic neutropenia may be enrolled with an absolute neutrophil count of ≥1.0 × 109 cells\u002FL\n   2. Hemoglobin ≥9.0 g\u002FdL.\n   3. Platelet count of ≥100,000\u002FµL.\n   4. International normalized ratio and activated partial thromboplastin time ≤1.5 times the ULN, except for subjects on direct acting anticoagulation.\n8. Has adequate liver function:\n\n   1. Total bilirubin 1.5 × ULN (except for subjects with documented Gilbert's Syndrome or liver metastases who must have a total bilirubin \\\u003C3 × ULN).\n   2. AST and ALT ≤2.5 × ULN (in subjects with liver metastases, \\\u003C5 × ULN is allowed).\n9. Has adequate renal function as defined by creatinine clearance ≥ 60 mL\u002Fmin by the Cockcroft-Gault equation.\n10. Women of childbearing potential and women who have ≤2 years amenorrhea after start of menopause, must have a negative serum or urine pregnancy test within 7 days prior to Cycle 1 Day 1.\n11. Contraception requirements:\n\n    1. Female subjects of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method (Pearl Index failure rate \\\u003C 1% per year) during the treatment period and for at least 6 months after the last dose of study drug.\n    2. Male subjects with female partners of childbearing potential must agree to using 2 acceptable methods of contraception (Pearl Index failure rate \\\u003C1% per year), including a barrier method (with or without spermicide) during the treatment period and for at least 6 months after the last dose of study drug.\n    3. Male subjects must agree to refrain from sperm donation during the treatment period and for at least 6 months after the last dose of study drug.\n12. The subject is willing and able to comply with the protocol, including any PK blood sampling and tumor biopsy requirements and agrees to return to clinic for follow-up visits and examinations.\n\n    1. For subjects in Phase 1a or 1b, on treatment tumor biopsy is optional. -\n\nExclusion Criteria:\n\n1. Has active or suspected central nervous system (CNS) metastases as determined by the Investigator. Subjects may still be eligible if CNS metastases are definitively treated with radiotherapy, the subject is asymptomatic, not requiring corticosteroids (prednisone or equivalent must be 10 mg\u002Fday or less), and have had repeat imaging no less than 4 weeks after completing radiotherapy to document stability.\n2. Subjects who have any history of an active (requiring treatment) other malignancy (except any in-situ carcinoma, non-melanoma skin carcinoma and early prostate cancer with a normal prostate-specific antigen) within 2 years of study entry.\n3. Has a significant, uncontrolled, concomitant disease that could affect compliance with the protocol.\n4. History or evidence of any other clinically unstable\u002Funcontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary, renal, metabolic, hematologic or psychiatric) other than their primary malignancy, that in the opinion of the Investigator would pose a risk to subject safety or interfere with study evaluations, procedures, or completion.\n5. History of known infection is defined as:\n\n   1. HIV infection defined as: An AIDS-defining infection within 12 months of planned study Day 1. Subjects on anti-retroviral treatment who are not established on anti-retroviral treatment for ≥4 weeks and who have a viral load \\>400 copies\u002FmL prior to study Day 1.\n   2. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection defined as: a positive hepatitis B surface antigen (HBsAG) test at screening. Subjects with a past or resolved HBV infection (defined as having a negative HBsAG test and a positive antibody to hepatitis B core antigen antibody test) are eligible. Subjects positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n   3. Chronic HBV (HBsAg positive, undetectable or low HBV DNA and normal ALT).\n   4. Subjects with active disease who are not on\u002Fhave not initiated anti-retroviral treatment prior to study Day 1.\n   5. Subjects with untreated HCV infection or have not completed treatment for HCV infection.\n   6. Subjects with treated HCV infection but with an HCV viral load above the level of quantification.\n   7. Has a severe infection (requiring IV antibiotic treatment) within 21 days prior to Cycle 1, Day 1 including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.\n6. Has any other clinically significant active disease, metabolic dysfunction, physical examination finding, altered mental status, clinical laboratory finding, or reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug in the opinion of the investigator.\n7. Has had major surgery within 21 days prior to Cycle 1, Day 1 (excluding biopsies) or anticipates the need for major surgery during study treatment.\n8. Is a pregnant or breastfeeding woman.\n9. Has a known hypersensitivity to any of the components of AVA6103 or any excipient of the product or to other topoisomerase 1 (TOP1) inhibitors.\n10. Has received prior investigational therapy (defined as a treatment for which there is no Regulatory Authority-approved indication) within 5 half-lives or 28 days (whichever is shorter) of Cycle 1 Day 1.\n11. Has received any approved anticancer therapy, including chemotherapy or hormonal therapy, within 14 days (or 5 half-lives, whichever is shorter) prior to Cycle 1 Day 1, with the following exception:\n\n    1. Is planned for on-study treatment or has received within 14 days (or 5 half-lives, whichever is shorter) prior to Cycle 1 Day 1.\n    2. Subjects who have received a monoclonal antibody.\n12. Is currently taking St John's Wort, any drugs that are a strong inhibitor or inducer of cytochrome P450 (CYP)3A4, CYP1A2, CYP2D6, or P-glycoprotein (P-gp) such as ketoconazole, Nifedipine, erythromycin and fentanyl.\n13. Drugs which are strong inhibitors of multidrug resistance protein (MRP)2, MRP3 or MRP4.\n14. Is planned for on study treatment with any drugs that are sensitive CYP3A4 or organic anion transporting polypeptide (OATP)1B3 substrates, and\u002For where these drugs will be in the systemic circulation at the start of Cycle 1, Day 1. For this protocol, it means that the drug must not be used within 5 half-lives (or 5 days, whichever is longer) prior to AVA6103 Cycle 1 Day 1 and during study treatment.\n15. Has received granulocyte-colony stimulating factor (G-CSF), or red blood cell or platelet transfusion within 14 days prior to Cycle 1 Day 1.\n16. Has received radiotherapy within 28 days prior to Cycle 1 Day 1, except for limited field palliative radiotherapy, which requires at least a 7-day washout period.\n17. Has received live attenuated vaccine within 30 days prior to Cycle 1 Day 1. Note: If a COVID-19 vaccine is administered it should be done \\>96 hours prior to AVA6103 administration. For the dose escalation phase, it should be administered after completion of the DLT period.\n18. QT interval corrected through use of Fridericia's formula (QTcF) \\> 470 ms demonstrated by at least two single ECGs ≥ 30 minutes apart.","ALL","18 Years",{"count":20,"type":21},174,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a first-in-human (FIH), Phase 1 open-label, multicenter dose escalation study investigating AVA6103 monotherapy administered intravenously in patients with locally advanced (unresectable) or metastatic solid tumors that are likely to be FAP positive. The study consists of an initial Phase 1a dose escalation portion and a subsequent Phase 1b dose expansion portion upon completion of the dose escalation portion.",[27,28,29,30,31,32,33,34,35],"Vulvar Adenocarcinoma","PDAC - Pancreatic Ductal Adenocarcinoma","Gastric Adenocarcinoma","GEJ Adenocarcinoma","Cervical Adenocarcinoma","Cervical Adenosquamous Carcinoma","Small Cell Carcinoma of Lung","Colorectal Cancer","Hormone Receptor Positive Breast Carcinoma","RECRUITING","2026-05-29",{"date":39,"type":40},"2026-06-02","ACTUAL",{"date":42,"type":40},"2026-03-31",{"date":44,"type":21},"2030-06",{"name":46,"class":47},"Avacta Life Sciences Ltd","INDUSTRY",3,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100436943","phase-1-a-study-evaluating-the-safety-pharmacokinetics-and-early-efficacy-of-ava6000-in-solid-tumours-100436943","NCT04969835","A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours","A Phase 1, Open Label, Dose-Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics and Initial Therapeutic Activity of AVA6000, a Novel FAP-activated Doxorubicin Administered Intravenously in Patients With Locally Advanced or Metastatic Selected Solid Tumours","Inclusion Criteria:\n\n1. The patient has been fully informed about the study and has signed the Informed Consent Form.\n2. Male or female patients, ≥ 18 years of age.\n3. a) Phase 1a: patients with tumours reported to be FAP positive with histological or cytological confirmation of a locally advanced (unresectable) and\u002For metastatic:\n\n   a. salivary gland, urothelial, ovarian, or breast carcinoma, who have either relapsed or progressed on SoC treatment or are intolerant or nonamenable to SoC treatment; OR b. soft-tissue sarcoma who: i. is treatment naïve in the locally advanced (unresectable) or metastatic setting and anthracycline naïve (any setting) and would otherwise be a candidate for doxorubicin hydrochloride treatment; OR ii. has received a total doxorubicin dose of \\\u003C 150mg\u002Fm2 (any setting (\\\u003C 2 cycles of 75 mg\u002Fm2 Q21 days) and has discontinued due to intolerance or toxicity related to doxorubicin\n\n   b) Phase 1b: patients with histological or cytological confirmation of a locally advanced (unresectable) and\u002For metastatic tumour of one of the following types:\n   1. High grade soft tissue sarcoma: histologically proven locally advanced or metastatic, unresectable progressive or recurrent DDLS or UPS who have received 0 or 1 prior lines of therapy in the locally advanced or metastatic setting\n   2. SGC: Locally advanced or metastatic salivary gland confirmed by histopathology that cannot be completely resected by surgery who have received 0 or 2 prior lines of therapy in the locally advanced or metastatic setting. In addition, patients with adenoid cystic carcinoma subtypes must not have received prior cytotoxic therapy for locally advanced or metastatic disease. Adenoid cystic carcinoma subtype may be capped at 15 patients (assuming cohort of approximately 30 patients)\n   3. TNBC: Locally advanced or metastatic triple negative breast cancer confirmed by histopathology who have received any prior therapy in the locally advanced or metastatic setting. Patients must be BRCA wild-type.\n4. In Phase 1b, patients must meet the following additional criteria:\n\n   Patients must demonstrate (as documented, per the investigator's assessment), radiological disease progression over the 6 months (±2 months) prior to screening. However, this requirement does not apply if the patient is newly diagnosed, recurrent or newly metastatic.\n   * Patients must have measurable disease per RECIST.\n   * Patients with high grade soft tissue sarcoma or salivary gland cancer must not have previously received an anthracycline-based therapy.\n   * Patients with TNBC may receive up to 250mg\u002Fm2 of prior doxorubicin (or an equivalent anthracycline). Prior anthracycline based therapy must have been completed at least 6 months before the planned Cycle 1 Day 1 AVA6000 infusion. Prior anthracycline use must have been in the adjuvant or neoadjuvant setting only.\n   * Patients must provide at least 1 tissue sample collection, either archival or fresh tissue (approximately 10 slides) unless the biopsy is medically not able to be performed or the principal investigator deems it is not medically feasible.\n5. Has a life expectancy of ≥12 weeks, in the opinion of the investigator.\n6. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.\n7. Has recovered from all acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure (must have resolved to CTCAE grade ≤1 or returned to baseline, except alopecia and peripheral neuropathy, which can be up to CTCAE grade 2).\n8. Has adequate haematological function (applies only to patients not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose):\n\n   * Absolute Neutrophil count (ANC) of ≥1.5 × 109 cells\u002FL.\n   * Haemoglobin ≥9.0 g\u002FdL.\n   * Platelet count of ≥75,000\u002FµL.\n   * International normalised ratio (INR) and activated partial thromboplastin time (aPTT) ≤1.5 times the upper limit of normal (ULN).\n9. Has adequate liver function:\n\n   * Total bilirubin below ULN (except for patients with Gilbert's Syndrome who must have a total bilirubin \\\u003C3 × ULN).\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN (in patients with liver metastases, \\\u003C5 × ULN is allowed).\n   * Alkaline phosphatase (ALP) \\\u003C5 × ULN in patients with documented liver or bone metastases, or ALP \\\u003C 2 × ULN in patients without documented metastases.\n10. Has adequate renal function (creatinine clearance ≥50 mL\u002Fmin by Cockcroft-Gault formula) or patients with normal plasmatic creatinine despite creatinine clearance \\\u003C 50 mL\u002Fmin as per Cockcroft-Gault formula are eligible for the study.\n11. Women of childbearing potential (WOCBP) and women who have ≤ 2 years amenorrhea after start of menopause: has a negative serum pregnancy test within 7 days prior to Cycle 1 Day 1.\n12. Contraception requirements:\n\n    * Female patients of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method (Pearl Index failure rate \\\u003C1% per year) during the treatment period and for at least 6 months after the last dose of study drug.\n    * Male patients with female partners of childbearing potential must agree to using 2 acceptable methods of contraception (Pearl Index failure rate \\\u003C1% per year), including a barrier method (with or without spermicide) during the treatment period and for at least 6 months after the last dose of study drug.\n    * Male patients must agree to refrain from sperm donation during the treatment period and for at least 6 months after the last dose of study drug.\n13. All patients should have peripheral veins or central line that are, in the opinion of the Investigator or delegate, suitable for peripheral or central intravenous infusion of AVA6000.\n14. The patient is willing and able to comply with the protocol, including any PK blood sampling requirements and agrees to return to hospital for follow-up visits and examinations.\n\nExclusion Criteria:\n\n1. Has received trastuzumab within 7 months of the planned Cycle 1 Day 1 AVA6000 infusion.\n2. Has received a prior total cumulative anthracycline dose of ≥ 350 mg\u002Fm2 doxorubicin (or equivalent anthracycline dose).\n3. Has clinically significant or untreated central nervous system (CNS) metastases or leptomeningeal disease requiring treatment, as determined by the Investigator.\n4. Patients who have any history of an active (requiring treatment) other malignancy (except any in-situ carcinoma, non-melanoma skin carcinoma and early prostate cancer with a normal PSA) within 2 years of study entry.\n5. Has a significant, uncontrolled, concomitant disease that could affect compliance with the protocol.\n6. In the opinion of the investigator, has uncontrolled hypertension (systolic blood pressure \\>150 mm Hg and\u002For diastolic blood pressure \\>100 mm Hg), unstable angina, CHF (New York Heart Association (NYHA) Class \\>II), left ventricular ejection fraction (LVEF) \\\u003C55% or the low limit of institutional normal limit (whichever is lower) by echocardiogram (ECHO), serious cardiac arrhythmia requiring treatment (exceptions include atrial fibrillation, paroxysmal supraventricular tachycardia), history of myocardial infarction within 6 months prior to Cycle 1 Day 1, or history of uncontrolled cardiovascular disease or high-sensitivity troponin above normal at baseline (T or I).\n7. Has a screening baseline mean corrected QTcF interval by Fridericia (QTcF) of \\>480 msec. Electrocardiograms (ECGs) will be evaluated locally at the investigator site. Has any clinically significant abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \\>250 msec). Has any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, known family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval, a baseline resting bradycardia \\\u003C45 beats\u002Fmin or a baseline resting tachycardia of \\>100 beats\u002Fmin.\n8. HIV infection:\n\n   * Patients with an AIDS-defining infection within 12 months of planned study Day 1.\n   * Patients on anti-retroviral treatment who are not established on anti-retroviral treatment for ≥4 weeks and who have a viral load \\> 400 copies\u002FmL prior to study Day 1.\n9. Active hepatitis B (HBV) or hepatitis C (HCV) infection defined as:\n\n   1. Has a positive hepatitis B surface antigen (HBsAG) test at screening. Patients with a past or resolved HBV infection (defined as having a negative HBsAG test and a positive antibody to hepatitis B core antigen \\[antiHBc\\] antibody test) are eligible.\n   2. Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA.\n   3. Chronic HBV (HbSAg positive, undetectable or low HBV DNA and normal ALT).\n   4. Patients with active disease who have not on\u002Finitiated anti-retroviral treatment prior to study Day 1.\n   5. Patients with untreated HCV infection or have not completed treatment for HCV infection.\n   6. Patients with treated HCV infection but with a HCV viral load above the level of quantification.\n10. Has a severe infection (requiring iv treatment) within 21 days prior to Cycle 1, Day 1 including, but not limited to, hospitalisation for complications of infection, bacteraemia, or severe pneumonia.\n11. Has any other clinically significant active disease, metabolic dysfunction, physical examination finding, clinical laboratory finding, or reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug in the opinion of the investigator.",{"count":57,"type":21},158,[24],"This is a first-in-human (FIH), Phase 1 open-label, multicentre dose escalation study investigating AVA6000 monotherapy administered intravenously in patients with locally advanced (unresectable) or metastatic solid tumours that are likely to be FAP positive. The study consists of an initial Phase 1a dose escalation portion and a subsequent Phase 1b dose expansion portion upon completion of the dose escalation portion.",[61,62,63,64,65],"Salivary Gland Tumor","Urothelial Carcinoma","Ovarian Carcinoma","Breast Cancer","Soft Tissue Sarcoma","2026-05-13",{"date":68,"type":40},"2026-05-15",{"date":70,"type":40},"2021-07-16",{"date":72,"type":21},"2026-08-15",{"name":46,"class":47},9,""]