AssociatiNG Bevacizumab bEmarituzumab for GynecoLogIcal CAncer (NCT07146919) | Clinical Trial Compass
WithdrawnPhase 1/2
AssociatiNG Bevacizumab bEmarituzumab for GynecoLogIcal CAncer
Stopped: Molecule not available from the laboratory
0Started 2025-10-15
Plain-language summary
The aim of this study is to determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of bemarituzimab given in combination with a fixed dose of bevacizumab and to assess the clinical activity of the proposed combination bemarituzumab and bevacizumab in 3 parallel and independent cohorts of gynecological cancer (endometrium, ovary and cervix).
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
I1. Female patients ≥ 18 years of age at time of ICF signature.
I2. Patients must have histologically or cytologically confirmed locally advanced or metastatic gynaecological cancer including
* Cohort I - all endometrial carcinoma (endometroid, serous, carcinosarcoma and undifferentiated or clear cell carcinoma). Uterine neuroendocrine carcinoma and uterine sarcoma are not eligible.
* Cohort II - high grade ovarian cancer patients (endometrioid, serous, clear cell, carcinosarcoma), platinum resistant. Note 1: Patients who have only had 1 prior line of platinum based therapy must have received at least 4 cycles of platinum, must have had a response (complete response/remission \[CR\] or partial response/remission \[PR\]) and then progressed between \> 3 months and ≤ 6 months after the date of the last dose of platinum; patients who have received 2 or 3 prior lines of platinum therapy must have progressed on or within 6 months after the date of the last dose of platinum; patients allergic to platinum and unable to reintroduce platinum despite a desensitisation technique are eligible. Beyond 3 prior lines, no specific requirements about PD on platinum. Note 2: Platinum-Resistant Ovarian Cancer (PROC) with high folate receptor-alpha expression should have received mirvetuximab soravtansine if reimbursed before to be included.
* Cohort III - squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix.
I3. Previously treated by at least…
What they're measuring
1
Dose escalation part : Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)