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
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
-
Carboplatin + Paclitaxel administered at each cycle of 21 days (in total 3 cycles).
- DRUG
-
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
- collaborator INDUSTRY
-
ARCAGY/ GINECO GROUP
lead OTHER
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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