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AssociatiNG Bevacizumab bEmarituzumab for GynecoLogIcal CAncer

NCT07146919 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2026-04-23

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Bemarituzumab

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

DRUG

Bevacizumab

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

Sponsors & Collaborators

  • Centre Leon Berard

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-15
Primary Completion
2030-10-15
Completion
2030-10-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07146919 on ClinicalTrials.gov