AssociatiNG Bevacizumab bEmarituzumab for GynecoLogIcal CAncer

Sponsor
Centre Leon Berard
Study ID
NCT07146919
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bemarituzumab — DRUG
    Part 1 Dose escalation part : IV infusion, every 3 weeks with the dose : DL1 = 15 mg/kg cycle 1 day 1, then 11 mg/kg thereafter from cycle 2 day 1 DL2 = 22 mg/kg cycle 1 day 1, then 15 mg/kg thereafter from cycle 2 day 1 DL3 = 30 mg/kg cycle 1 day 1, then 22 mg/kg thereafter from cycle 2 day 1 Part 2 Extension part : IV infusion, every 3 weeks with the dose defined in the phase I dose escalation Treatment with both study drugs will continue until disease progression according to RECIST v1.1, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurs first
  • Bevacizumab — DRUG
    IV infusion, 15mg/kg, every 3 weeks. Treatment with both study drugs will continue until disease progression according to RECIST v1.1, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurs first

Study Details

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).

Key Dates

First listed
Aug 28, 2025
Start date
Oct 15, 2025
Status verified
Apr 2026
Primary completion
Oct 15, 2030
Completion
Oct 15, 2030

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Patient with endometrial cancer
    Patients must have histologically or cytologically confirmed locally advanced or metastatic endometrial carcinoma (endometroid, serous, carcinosarcoma and undifferentiated or clear cell carcinoma), uterine neuroendocrine carcinoma and uterine sarcoma are not eligible, and with a gynecological cancer overexpressed FGFR2b by immunohistochemistry testing.
  • Experimental: Patient with ovarian cancer
    Patients must have histologically or cytologically confirmed locally advanced or metastatic high grade ovarian cancer patients (endometrioid, serous, clear cell, carcinosarcoma), platinum resistant and with a gynecological cancer overexpressed FGFR2b by immunohistochemistry testing.
  • Experimental: Patient with cervix cancer
    Patients must have histologically or cytologically confirmed locally advanced or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix and with a gynecological cancer overexpressed FGFR2b by immunohistochemistry testing.

Primary Outcome Measure

Dose escalation part : Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) [ Time Frame: 6 weeks ]

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