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

NCT07637851 | Not Yet Recruiting Phase 1 DMC

• 2 other identifiers: GINECO-OV133b2025-524232-20-00
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 11

Brief 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

Ovarian Cancer

Keywords

chemotherapy; poor prognostic; unfavorable primary chemosensitivity; incomplete debulking surgery; KELIM

Outcome Measures

Primary Outcomes (4)

• Safety run-in phase I : Safety and recommended dose for phase II trial during the Dose-limiting toxicities monitoring period

  Incidence of Treatment emergent adverse events according to NCI CTCAE version 6.0 (Safety and Tolerability)

  Up to 4 weeks of treatment

• Safety run-in phase I : Safety and recommended dose for phase II trial during the Dose-limiting toxicities monitoring period

  Dose-limiting toxicities (DLT) occurring during the DLT period (Safety and Tolerability)

  Up to 4 weeks of treatment

• Safety run-in phase I : Safety and recommended dose for phase II trial during the Dose-limiting toxicities monitoring period

  The recommended dose for phase II trial (RP2D) of ubamatamab in combination with carboplatin-paclitaxel + bevacizumab

  From Cycle 1 Day 1 of the first patient included to Cycle 3 Day 1 of the sixth patient included (each cycle is 21 days) (Safety and Tolerability)

• Efficacy phase II part

  Objective response rate (ORR): Percentage of patients experiencing complete (CR) or partial response (PR) as the best overall radiological response after 3 cycles of ubamatamab in combination with carboplatin-paclitaxel-bevacizumab based on RECIST 1.1 criteria

  1 month after Cycle 3 Day 1 of the sixth patient included (each cycle is 21 days).

Secondary Outcomes (8)

• Safety during the whole treatment period

  From study treatment start to 90 days after the last dose of ubamatamab

• Objective response rate (ORR)

  Through study treatment completion, an average of 15 months.

• Duration of response in patients experiencing an objective response

  From study treatment start to disease progression or death whichever occurs first assessed up to 48 months.

• Disease control rate (DCR)

  From study treatment start to end of treatment, an average of 15 months.

• Percentage of patients operated with late cytoreductive surgery

  After 3 cycles of treatment (each cycle is 21 days).

Study Arms (1)

Carboplatin-paclitaxel-bevacizumab + ubamatamab

EXPERIMENTAL

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.

Drug: Ubamatamab; Drug: Chemotherapy; Drug: Bevacizumab; Drug: GCSF

Interventions

Ubamatamab DRUG

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

Carboplatin-paclitaxel-bevacizumab + ubamatamab

Chemotherapy DRUG

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

Carboplatin-paclitaxel-bevacizumab + ubamatamab

Bevacizumab DRUG

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

Carboplatin-paclitaxel-bevacizumab + ubamatamab

GCSF DRUG

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

Carboplatin-paclitaxel-bevacizumab + ubamatamab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed high-grade epithelial (serous, endometrioid, or carcinosarcoma with a ≥30% epithelial tumor component) ovarian, primary peritoneal, or fallopian-tube carcinoma
• Adult patient aged ≥ 18 years old
• Advanced stage III or IV
• Treated with 3 or 4 standard neo-adjuvant cycles of carboplatin-paclitaxel regimen, in first line, given every 3 weeks, and characterized by 2 unfavorable features (both are required):
• A poorly chemosensitive disease defined by an unfavorable standardized KELIM score \< 1.0 calculated on CA-125 KELIM™ calculator for patients treated with neo-adjuvant chemotherapy
• A disease considered not amenable to complete interval cytoreductive surgery with no post-operative macroscopic residual lesion (either because the interval cytoreductive surgery attempt was incomplete CC2-CC3, or because the surgeon considers a complete interval cytoreductive surgery is not achievable based on imaging and/or laparoscopic explorations)
• Disease measurable and assessable by imaging based on RECIST 1.1 criteria (thorax-abdomen-pelvis CT-scanner; FDG-PET-CT-scanner; and/or MRI)
• Availability of a tumor tissue for translational research (archival tissue, or alternatively from fresh biopsy, and/or surgery)
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• BRCA and HRD status known, or planned during the trial (before maintenance treatment)
• Adequate bone marrow function
• Red blood cells: baseline Hemoglobin ≥8 g/dL (without red blood cell transfusion within 3 weeks before the blood work)
• White blood cells: Absolute neutrophil count (ANC) ≥1500 cells/mm3
• Platelets: Platelet count ≥100,000/mm3
• Adequate renal and liver functions

Sponsors & Collaborators

• ARCAGY/ GINECO GROUP: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (11)

Institut Bergonié

Bordeaux, 33076, France

Location

Centre François Baclesse

Caen, 14076, France

Location

Centre Georges François Leclerc

Dijon, 21079, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

Institut Paoli Calmettes

Marseille, 13273, France

Location

ICM Val d'Aurelle

Montpellier, 34298, France

Location

HCL - Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Centre Eugène Marquis

Rennes, 35042, France

Location

ICO - Centre René Gauducheau

Saint-Herblain, 44805, France

Location

Hôpital de Hautepierre

Strasbourg, 67098, France

Location

Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Drug Therapy; Bevacizumab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Benoit YOU

  HCL - Centre Hospitalier Lyon Sud

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mihary ANDRIAMAMONJY

CONTACT

01 84 85 20 09; mandriamamonjy@arcagy.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): April 1, 2030
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (11)