AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Study of TUB-040 Given With Standard Ovarian Cancer Drugs in Patients With Fast-growing Ovarian Cancer

RecruitingPhase 1, Phase 2Ages 18 Years - anyFemaleGilead Sciences
💬

In plain words

What the trial is, and whether it could suit you

The goal of this clinical study is to learn more about the safety, tolerability, and preliminary effectiveness of TUB-040 when given in combination with standard ovarian cancer treatments in participants with high-grade epithelial serous or endometrioid ovarian cancer. This study will also evaluate the appropriate dose of TUB-040 when used with carboplatin (Carbo) and bevacizumab (BEV), including determining the maximum tolerated dose (MTD) in participants with platinum-sensitive ovarian cancer.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Female ≥ 18 years of age at the time of the first screening visit 2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 3. Histologically confirmed advanced high-grade serous or endometrioid epithelial ovarian, fallopian tube or primary peritoneal cancer. 4. Have platinum-sensitive ovarian cancer (PSOC) defined as: Patients who had recurrences (radiologically confirmed) to platinum-based therapy and have responded to the last platinum therapy received before study entry and did not progress within 6 months (182 days) of the date of the last dose of platinum-based systemic treatment. 5. Radiologically measurable disease in at least 1 lesion by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1, that can include a lesion in an irradiated field and that shows progression according to RECIST v1.1 6. Patients must have progressed radiographically on or after their most recent line of anticancer therapy 7. Adequate hematologic function as indicated by: 1. Platelet counts ≥100,000/mm3 (no transfusion or growth factors, e.g., eltrombopag, romiplostim, or IL-11 within 4 weeks before first dose) 2. Hemoglobin ≥9.0 g/dL (no transfusion or growth factors e.g. erythropoietin (EPO), darbepoetin within 4 weeks before first dose or long-acting white blood cell growth factors within 20 days before first dose) 3. Absolute neutrophil count (ANC) ≥1500/μL (no growth factors, e.g., granulocyte colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF) within 4 weeks before first dose) 4. International normalized ratio (INR) ≤1.5 and activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN) in the absence of anticoagulation therapy. If patients are on anticoagulation therapy with a specific INR goal, INR should be within the therapeutic range for the medical indication. 8. Adequate hepatic function defined as total bilirubin level ≤1.5 × ULN, an aspartate aminotransferase (AST) level ≤2.5 × ULN, and an alanine aminotransferase (ALT) level ≤2.5 × ULN 1. For documented Gilbert's Syndrome, a total bilirubin \<3 × ULN is accepted 2. For patients with liver metastases, AST and ALT \<5 × ULN is accepted 9. Alkaline phosphatase \< 2.5 x ULN, except if there is an alternative explanation for ALP elevation rather than hepatic failure, such as the presence of bone metastasis 10. Adequate renal function defined by glomerular filtration rate ≥60 mL/min (according to the Chronic Kidney Disease Epidemiology Collaboration, CKD-EPI, formula \[Appendix B\]). 11. Patients must be willing to sign an archival tissue release form for research purposes and determination of biomarker (e.g., NaPi2b) expression. The patient must have an adequate tumor tissue sample available for biomarker assessment by the central laboratory. Mandatory is either a tissue (FFPE) block or a minimum of 6 freshly cut unstained sections based on the most recently available tumor sample. If no archival specimens are available, a new biopsy must be performed. For patients in which a fresh biopsy poses unacceptable clinical risk in the judgment of the treating investigator, enrollment may be considered on a case-by-case basis only after discussion with the Sponsor Medical Monitor. 12. Resolution of all acute toxic effects of prior therapy or surgical procedures to Grade ≤1 including peripheral neuropathy (except alopecia, hyperpigmentation, or discoloration (incl. vitiligo) of the skin and nails, stable immune-related toxicity such as hypothyroidism on hormone) replacement, corticosteroid treatment on ≤10 mg daily prednisone (or equivalent) 13. Patients with previous systemic topoisomerase 1 inhibitor treatment (e.g., Topotecan) or patients that are previously treated with ADCs are allowed (except for ADCs with a topoisomerase 1 inhibitor, such as SN38 or other camptothecin derivatives as payload or any ADC targeting NaPi2b) 14. Completed washout of prior therapy: 1. Systemic anti-neoplastic therapy: five half-lives or 4 weeks, whichever is shorter prior to first dose of study drug. Hormonal therapy is not considered anti-neoplastic therapy. 2. Radiotherapy: last dose ≥ 2 weeks from first dose of study drug 3. Completed major surgery at least 4 weeks prior from first dose of study drug and recovered from side effects to Grade ≤1. 15. Viral infections: 1. Patients who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B (HBV) anti-viral therapy for at least 4 weeks and have undetectable HBV viral load Note: Patients should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post-completion of study intervention. 2. Patients with history of hepatitis C viral (HCV) infection are eligible if HCV viral load is undetectable at screening. Note: Patients must have completed curative anti-viral therapy at least 4 weeks before enrollment 16. Women of childbearing potential (WOCBP) who are sexually active with a non-sterilized partner must use at least 1 highly effective method of contraception (with a failure rate of ≤1% per year) from the time of screening and must agree to continue using such precautions until the end of exposure, plus at minimum 5 half-lives and 6 months after last dose of either TUB-040, carboplatin, or bevacizumab, whichever is later, in the case of patients of childbearing potential. Abstinence is acceptable only when this is in line with the preferred and usual lifestyle of the patient for the duration of the study treatment and the above-referred period after the end of the exposure. Periodic abstinence (e.g. calendar ovulation, symptom-thermal, post-ovulation methods), the rhythm method, and the withdrawal method are not acceptable methods of contraception. Note: A pregnancy test (urine or serum test or per institutional guideline) 72 hours before enrollment is required in WOCBP. With
💊

What it tests

  • TUB-040 + Carbo + BEV
📍

Where

8 sites
Start Cal
Los Angeles, United States
Start Njeb
East Brunswick, United States
Start Nyli
New York, United States
UCL Louvain
Brussels, Belgium
UZ Gent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
CHU de Liege
Liège, Belgium
ARENSIA Exploratory Medicine
Kyiv, Ukraine
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy