Safety and Efficacy of Ubamatamab With First-line Chemotherapy in Ovarian Cancer

NCT07637851 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2026-07-10

No results posted yet for this study

Summary

The purpose of this clinical trial is to assess the safety and efficacy of ubamatamab in combination with first-line chemotherapy in patients with ovarian cancer. The main questions it aims to answer are:

* What is the safety profile of ubamatamab when administered with carboplatin-paclitaxel ± bevacizumab?
* What is the objective response rate after three cycles of ubamatamab in combination with carboplatin-paclitaxel ± bevacizumab?

Participants will:

* Receive three cycles of ubamatamab in combination with carboplatin-paclitaxel ± bevacizumab, followed by maintenance therapy with ubamatamab ± bevacizumab for up to 15 months, depending on HRD status and disease response after the initial treatment cycles.
* Attend regular clinic visits throughout the treatment period for checkups and tests

Conditions

Interventions

DRUG

Ubamatamab

Dosage form: Solution for perfusion Dosage: 5 mg/mL; 50 mg/mL Frequency: administration every three weeks Treatment duration: 15 months

DRUG

Chemotherapy

Carboplatin + Paclitaxel administered at each cycle of 21 days (in total 3 cycles).

DRUG

Bevacizumab

Bevacizumab administered at each cycle of 21 days (3 cycles in total) then during maintenance therapy every 3 weeks.

DRUG

GCSF

Administered at each cycle during the 3 first cycles of the drug combination (chemotherapy + bevacizumab + ubamatamab).

Sponsors & Collaborators

Principal Investigators

  • Benoit YOU · HCL - Centre Hospitalier Lyon Sud

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-09-30
Completion
2030-04-30

Countries

  • France

Study Locations

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Entities

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 NCT07637851 on ClinicalTrials.gov