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

Sponsor
ARCAGY/ GINECO GROUP
Study ID
NCT07637851
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Ubamatamab — DRUG
    Dosage form: Solution for perfusion Dosage: 5 mg/mL; 50 mg/mL Frequency: administration every three weeks Treatment duration: 15 months
  • Chemotherapy — DRUG
    Carboplatin + Paclitaxel administered at each cycle of 21 days (in total 3 cycles).
  • Bevacizumab — DRUG
    Bevacizumab administered at each cycle of 21 days (3 cycles in total) then during maintenance therapy every 3 weeks.
  • GCSF — DRUG
    Administered at each cycle during the 3 first cycles of the drug combination (chemotherapy + bevacizumab + ubamatamab).

Study Details

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

Key Dates

First listed
Jun 10, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Sep 30, 2028
Completion
Apr 30, 2030

Study Design

Enrollment
43 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Carboplatin-paclitaxel-bevacizumab + ubamatamab
    All participants will receive 3 cycles of the combination carboplatin-paclitaxel-bevacizumab + ubamatamab. After the 3 cycles, they will undergo surgery if it is feasible. Subsequently, they will receive maintenance treatment: * ubamatamab + bevacizumab: for participants with BRCA wild-type and HRD negative tumors and for participants with a disease characterized by a BRCA mutation, or HRD positive status, and experiencing stable disease during the chemotherapy * Olaparib + bevacizumab (standard of care): for participants with a disease characterized by a BRCA mutation, or HRD-positive status, and experiencing complete or partial response during the chemotherapy.

Primary Outcome Measure

Safety run-in phase I : Safety and recommended dose for phase II trial during the Dose-limiting toxicities monitoring period [ Time Frame: Up to 4 weeks of treatment ]

Central Contacts

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