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Ovarian CancerPhase 1/2RegeNovarNCT07637851

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

A Phase 1/2 study testing Ubamatamab, Chemotherapy and Bevacizumab in people with Ovarian Cancer, run by ARCAGY/ GINECO GROUP at 11 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Ubamatamab, Chemotherapy and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
11 sitesFrance
Study dates
Aug 2026to Apr 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN), or ≤5 × ULN in context of liver metastases
  • Total bilirubin ≤1.5 × ULN (patients with Gilbert's are eligible if total bilirubin ≤3 × ULN)
  • Albumin ≥3 g/dL
  • Creatinine clearance ≥40 mL/min/1.73 m2 (measured or estimated, ideally with CKD-EPI formula on https://www.kidney.org/professionals/kdoqi/gfr_calculator )
  • Adequate heart function: LVEF ≥ 50%, measured by echocardiogram, and troponin levels above the upper limit of normal (ULN). The case of troponin level comprised between 1.0 and 2 ULN, inclusion may be discussed after cardiological assessment.
  • Life expectancy of at least 3 months
  • Patients who gave their written informed consent to participate to the study
  • Patients affiliated to a social insurance regime
  • Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up.
  • Non-inclusion Criteria:
  • Low-grade endometrioid, clear cell, mucinous, or sarcomatous histology, or mixed tumors containing any of these histologies, or low-grade or borderline ovarian tumor.
  • Patients with primary platinum-refractory disease, defined as disease that has radiologically progressed during the neo-adjuvant chemotherapy
  • Contraindication to ubamatamab
  • Contraindication to carboplatin, paclitaxel or bevacizumab
  • Previous treatment with bevacizumab during initial standard neo-adjuvant chemotherapy
  • Prior treatment with anti-PD-1 therapies or T-cell therapies, or any other experimental anti-cancer systemic therapy
  • Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 2 years.
  • All trial participants with brain metastases, except those meeting the following criteria (all criteria are required):
  • Brain metastases that have been treated locally, and are clinically asymptomatic for at least 4 weeks prior to enrolment,
  • No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable).
  • Trial participants with brain metastases must be either off steroids except a stable or decreasing dose of <10mg daily prednisone (or equivalent).
  • Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
  • Patients receiving any systemic chemotherapy, radiotherapy (except for symptomatic/palliative reasons), within 3 weeks before the first dose of ubamatamab. The patient can receive a stable dose of bisphosphonates for bone metastases, before and during the study if these were started at least 4 weeks prior to treatment with study drug.
  • Persistent toxicities (≥CTCAE grade 3), caused by previous cancer therapy
  • Treatment with other investigational agents.
  • Bowel occlusive syndrome, inflammatory bowel disease, immune colitis, or other gastro-intestinal disorder that does not allow oral medication, such as malabsorption.
  • Clinically significant (i.e., active) and severe cardiovascular disease according to investigator opinion such as myocardial infarction (< 6 months prior to enrollment); any history of myocarditis; significant arrhythmia including paroxysmal atrial fibrillation requiring intervention at any time or implantation of a pacemaker or defibrillator; signs or symptoms of active angina; arrhythmia or heart failure; LEVF < 50% with echocardiogram; QTc (Friedericia) interval >470 msec (in cases of asymptomatic prolonged QTc interval (>470 msec), the ECG can be repeated up to 2 times. If subsequent QTc interval is <470 msec, the patient may be enrolled but only after review and approval by a cardiologist); Evidence of Second-Degree AV block type II (Mobitz type II) or AV block type III (complete heart block); Baseline serum troponin above institutional upper limit of normal. In cases of minimally elevated troponin in absence of clinical symptoms, after clearance by a cardiologist, the patient may be enrolled.
  • Untreated pulmonary embolism (PE) or deep vein thrombosis (DVT), not currently managed with anticoagulant therapy. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immunological adverse events. The following are not exclusionary: vitiligo, childhood asthma that has resolved, hypothyroidism that required only hormone replacement, type 1 diabetes or psoriasis that does not require systemic treatment
  • Uncontrolled infection with human immunodeficiency virus, hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency or known latent tuberculosis infection.
  • Participants will be tested for HCV and HBV at screening per Section 5.2
  • Patients with HIV who have controlled infection (undetectable viral load and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are permitted.
  • Patients with hepatitis B surface antigen positive (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving antiviral therapy for hepatitis B) are permitted.
  • Participants with HBsAg negative but total HBV core antibody positive (HBc Ab+) are permitted with the following requirements: If serum HBV DNA PCR is above the limit of detection at screening, antiviral therapy for HBV must be initiated prior to study entry. If serum HBV DNA PCR is below the limit of detection periodic monitoring of HBsAg must be performed.
  • Patients who are Hepatitis C virus antibody positive (HCV Ab +) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted.
  • Other active infections requiring hospitalization or IV anti-infectives within 2 weeks before starting study treatment.
  • Receipt of a live vaccine within 30 days of planned start of study medication.
  • Pregnant or lactating patients or patients expecting to conceive children within the projected duration of the trial.
  • Women of childbearing potential (WOCBP)* who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose. Highly effective contraceptive measures include:
  • stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening
  • intrauterine device (IUD); intrauterine hormone-releasing system (IUS)
  • bilateral tubal occlusion/ligation
  • vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the study participant and that the vasectomized partner has obtained medical assessment of surgical success for the procedure) and/or e. sexual abstinence * * WOCBP are defined as women who are fertile following menarche until becoming postmenopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.
  • A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to determine the occurrence of a postmenopausal state. The above definitions are according to Clinical Trial Facilitation Group (CTFG) guidance.
  • Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient.
  • Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method (LAM) are not acceptable methods of contraception. Female condom and male condom should not be used together.
  • Known psychiatric disorder that would interfere with trial compliance.
  • Patient deprived of liberty, under guardianship, or under curatorship

Who cannot join

None listed.

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Mihary ANDRIAMAMONJY contact

01 84 85 20 09

mandriamamonjy@arcagy.org

11 sites in 1 country

France11 sites

  • Institut Bergonié

    Bordeaux, 33076

    Coriolan LEBRETON

  • Centre François Baclesse

    Caen, 14076

    Coraline DUBOT POITELON

  • Centre Georges François Leclerc

    Dijon, 21079

    Leïla BENGRINE LEFEVRE

  • Centre Léon Bérard

    Lyon, 69373

    Brunhilde HANVIC

  • Institut Paoli Calmettes

    Marseille, 13273

    Renaud SABATIER

  • ICM Val d'Aurelle

    Montpellier, 34298

    Stanislas QUESADA

  • HCL - Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

    Benoit YOU

  • Centre Eugène Marquis

    Rennes, 35042

    Thibault DE LA MOTTE ROUGE

  • ICO - Centre René Gauducheau

    Saint-Herblain, 44805

    Jean-Sébastien FRENEL

  • Hôpital de Hautepierre

    Strasbourg, 67098

    Laurianne EBERST

  • Gustave Roussy

    Villejuif, 94805

    Alexandra LEARY

Other trials in France

About this study

Official title: A Phase I/II Study of Ubamatamab Plus Carboplatin, Paclitaxel, and Bevacizumab as Salvage Therapy in Ovarian Cancer With Poor Response to First-Line Chemotherapy

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?
Read more

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
Being tested
Ubamatamab, Chemotherapy, Bevacizumab, GCSF
Keywords
chemotherapy, poor prognostic, unfavorable primary chemosensitivity, incomplete debulking surgery, KELIM
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UbamatamabDrug

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

  • ChemotherapyDrug

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

  • BevacizumabDrug

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

  • GCSFDrug

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

Study groups in NCT07637851
Study groupRoleWhat they receive
Carboplatin-paclitaxel-bevacizumab + ubamatamabExperimentalAll 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.
Receives: Drug: Ubamatamab; Drug: Chemotherapy; Drug: Bevacizumab; Drug: GCSF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Up to 4 weeks of treatment

  2. 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)

    Measured: Up to 4 weeks of treatment

  3. 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

    Measured: 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)

  4. 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

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

Secondary outcomes (8)

  1. Safety during the whole treatment period

    Incidence of Treatment emergent Adverse events according to NCI CTCAE version 6.0 during the whole treatment period (Safety and Tolerability)

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

  2. Objective response rate (ORR)

    Percentage of patients experiencing complete (CR) or partial response (PR) as the best overall radiological response during the whole study treatment period based on RECIST 1.1 criteria.

    Measured: Through study treatment completion, an average of 15 months.

  3. Duration of response in patients experiencing an objective response

    Time from first objective response to first objective documented disease progression (based on RECIST v1.1 criteria), or to death (regardless of the cause in the absence of disease progression).

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

  4. Disease control rate (DCR)

    Percentage of patients experiencing complete (CR) or partial response (PR) or stable disease (SD) as the best overall radiological response during the whole treatment period based on RECIST 1.1 criteria.

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

  5. Percentage of patients operated with late cytoreductive surgery

    To determine the percentage of patients operated with late cytoreductive surgery (after 3 cycles of the study regimen), and among them the percentage of patients operated with complete surgery without any macroscopic residual lesion.

    Patients who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment from their last evaluable RECIST assessment.

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

  6. Progression-free survival (PFS)

    Time from treatment start until the date of event defined as the first objective documented disease progression (based on RECIST v1.1 criteria) or death (regardless of the cause in the absence of progression).

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

  7. Overall survival (OS)

    Time from the date from treatment start until death regardless of the cause. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive.

    Measured: From study treatment start to death or end of study whichever occurs first assessed up to 48 months.

  8. Progression-free survival during subsequent line of treatment (PFS-ST)

    Time from the start of the subsequent line of treatment until the date of event defined as the first objective documented progression (based on RECIST v1.1), or death (regardless of the cause in the absence of progression).

    Measured: From new treatment start to progression or death whichever occurs first assessed up to 48 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2026
  2. Study startAug 2026 (estimated)
  3. Primary completionSep 2028 (estimated)
  4. Study completionApr 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07637851
Sponsor's protocol ID
GINECO-OV133b
Other IDs
2025-524232-20-00, 2025
Acronym
RegeNovar
Status last verified
Jul 2026
First submitted
14 Jan 2026
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ubamatamab, Chemotherapy and Bevacizumab in people with Ovarian Cancer, run by ARCAGY/ GINECO GROUP at 11 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 62 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mihary ANDRIAMAMONJY (01 84 85 20 09, mandriamamonjy@arcagy.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07637851.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

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