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Epithelial Ovarian CancerPhase 3NCT07811271

Efficacy and Safety of BG-C9074 With Bevacizumab Compared With Bevacizumab in Adults With Ovarian, Fallopian Tube, or Primary Peritoneal Cancers

A Phase 3 study testing BG-C9074 and Bevacizumab in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by BeOne Medicines.

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
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Trial summary

The purpose of this study is to evaluate the safety and efficacy of BG-C9074 with bevacizumab (Arm A) versus bevacizumab monotherapy (Arm B) in adults with epithelial ovarian, fallopian tube, or primary peritoneal cancers who have not progressed after firstline platinum-based chemotherapy plus bevacizumab. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
BG-C9074 and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
No sites listed yet
Study dates
Oct 2026to 31 Mar 2033
Phase
Phase 3
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

  • Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
  • Participants must have a histologically confirmed diagnosis of epithelial high-grade ovarian, fallopian tube or primary peritoneal carcinoma (serous, endometrioid, or clear cell).
  • Participants are newly diagnosed International Federation of Gynecology and Obstetrics (FIGO) stage III or IV and have received primary debulking surgery or interval debulking surgery.
  • Participants must have adequate organ function.
  • Women of childbearing potential must be willing to use a highly effective method of birth control and agree not to donate eggs (ova, oocytes) or freeze/store eggs for the duration of the study and for ≥ 7 months after the last dose of study treatment.

Who cannot join

  • Participants have ovarian, fallopian tube, or peritoneal cancer of nonepithelial origin.
  • Participants have either a germline or somatic BReast CAncer gene (BRCA) mutation as per local test.
  • Participants who will receive poly-adenosine diphosphate ribose polymerase (PARP) inhibitor as maintenance therapy per standard of care and investigator discretion.
  • Participants have a history of allergic reactions or hypersensitivity to the active ingredients and excipients of the drug products and other monoclonal antibodies.
  • Participants had previous transient ischemic attack, cerebrovascular accident, or subarachnoid hemorrhage within 6 months prior to randomization
  • Participants have evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation therapy).
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

BeOne Medicines contact

1.877.828.5568

clinicaltrials@beonemed.com

About this study

Official title: A Phase 3, Open-label, Multicenter, Randomized Study of BG-C9074 With Bevacizumab Versus Bevacizumab as First-line Maintenance Therapy for Patients With Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers Who Have Not Progressed After First-line Platinum-based Chemotherapy Plus Bevacizumab (Starstone-Ovarian 301/GOG-3144/ENGOT-ov108/APGOT-OV29)

The purpose of this study is to evaluate the safety and efficacy of BG-C9074 with bevacizumab (Arm A) versus bevacizumab monotherapy (Arm B) in adults with epithelial ovarian, fallopian tube, or primary peritoneal cancers who have not progressed after firstline platinum-based chemotherapy plus bevacizumab.

Read the detailed description

Ovarian cancer is a disease where abnormal cells in the ovaries or fallopian tubes grow out of control and form tumors. Common early signs include belly bloating, pelvic or back pain, feeling full quickly when eating, and frequent urination.

BG-C9074 is a targeted cancer medicine called an antibody-drug conjugate (ADC). ADC consists of an antibody linked to a drug that can kill cancer cells. The antibody part of BG-C9074 specifically attaches to a protein called B7-H4 that is found on the surface of cancer cells. After it attaches to B7-H4, BG-C9074 enters the cancer cell where the drug causes DNA damage and cell death. Bevacizumab is an approved medicine used to treat these cancers along with chemotherapy. It works by cutting off the blood supply that helps the tumor grow, which may help keep the cancer under better control.

The purpose of this study is to test if BG-C9074 is safe and effective in women with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer when it is given in combination with bevacizumab as a first-line maintenance treatment.

This study has 2 treatment groups. Participants will be randomly assigned (by chance, like flipping a coin) to receive one of the treatments listed below:

  • Arm A: BG-C9074 + Bevacizumab
  • Arm B: Bevacizumab

This study will enroll approximately 600 participants. The overall time to participate in this study may be up to 5 years. Participants will make regular visits to the clinic for treatment, health checks, blood tests, and for tumor and imaging tests.

Being tested
BG-C9074, Bevacizumab
Medical subject headings
Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms

What participants receive

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

  • BG-C9074Drug

    Administered by Intravenous infusion

  • BevacizumabDrug

    Administered by Intravenous infusion

Study groups in NCT07811271
Study groupRoleWhat they receive
Arm A: BG-C9074 + BevacizumabExperimentalBG-C9074 will be administered first, followed by bevacizumab.
Receives: Drug: BG-C9074; Drug: Bevacizumab
Arm B: BevacizumabActive comparatorBevacizumab will be administered alone.
Receives: Drug: Bevacizumab

What is being measured

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

  1. Progression-Free survival (PFS) assessed by Blinded Independent Central Review (BICR)

    PFS is defined as the time from randomization to the date of disease progression by BICR based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death, whichever occurs first.

    Measured: Up to 5 years

Secondary outcomes (9)

  1. Overall Survival (OS)

    OS is defined as the time from randomization to death due to any reason.

    Measured: Up to 5 years

  2. PFS, as Assessed by Investigator

    PFS is defined as time from randomization to the date of disease progression by Investigator based on RECIST v1.1 or death, whichever occurs first.

    Measured: Up to 5 years

  3. PFS2, as Assessed by Investigator

    PFS2, as assessed by investigator, is defined as time from randomization to the documented disease progression on first subsequent systemic therapy by Investigator or death due to any cause, whichever occurs first.

    Measured: Up to 5 years

  4. Time to Next Treatment

    Time to next treatment is defined as the time from randomization to the start of the first subsequent anticancer therapy after discontinuation of randomized treatment, or death due to any cause.

    Measured: Up to 5 years

  5. Number of Participants with Treatment-Emergent Adverse Events, Treatment-Related Adverse Events, and Serious Adverse Events

    An adverse event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment, whether considered related to study treatment or not.

    A serious adverse event is any untoward medical occurrence that, at any dose, meets one or more of the criteria listed in the view of either the investigator or the Sponsor:

    1. Results in death
    2. Is life-threatening
    3. Requires inpatient hospitalization or prolongation of existing hospitalization
    4. Results in persistent or significant disability/incapacity
    5. Is a congenital anomaly/birth defect

    Measured: From first dose of study drug up to 30 days after last dose, up to 24 months

  6. Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) - F17 Global Health Status/Quality of Life (GHS/QoL), Role Functioning, and Physical Functioning Domain Scores

    The EORTC QLQ-F17 is a 17-item questionnaire that covers GHS/QoL and five functional scales (Physical, Role, Emotional, Cognitive, and Social). All items are scored on a 4-point - Likert scale (1 = "Not at all"; 4 = "Very much"), except the two items of the GHS/QoL-scale that are scored on a 7-point scale (1 = "Very poor"; 7 = "Excellent"). Scores are averaged and transformed to a 0 to 100 scale. Higher scores in GHS/QoL and functional scales indicate better health-related quality of life (HRQoL).

    Measured: Baseline and up to approximately 2 years

  7. Change from Baseline in EORTC QLQ -Ovarian Cancer Module (OV28) Abdominal/GI Symptoms Domain Score

    The EORTC QLQ-OV28 includes a 28-item questionnaire for evaluating ovarian cancer-specific symptoms and concerns in participants of cancer clinical studies. These include items that assess symptoms in the abdominal/gastrointestinal domain. Scores are averaged and transformed to a 0 to 100 scale; higher scores indicate a greater symptom burden, while lower scores reflect fewer symptoms.

    Measured: Baseline and up to approximately 2 years

  8. Time to Deterioration (TTD) of GHS/QoL, Role Functioning, and Physical Functioning Domain Scores as Measured via EORTC QLQ - F17

    TTD of GHS/QoL is defined as the time from the date of randomization to the first confirmed clinically meaningful deterioration on the abdominal/gastrointestinal symptom domain of the EORTC QLQ-F17.

    Measured: Up to 5 years

  9. Time to deterioration (TTD) of Abdominal/GI Symptoms as Measured via EORTC QLQ - OV28

    TTD of Abdominal/GI Symptoms is defined as the time from the date of randomization to the first confirmed clinically meaningful deterioration on the abdominal/gastrointestinal symptom domain of the EORTC QLQ-OV28.

    Measured: Up to 5 years

Timeline

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

  1. First posted10 Sep 2026
  2. Study startOct 2026 (estimated)
  3. Primary completion30 Nov 2029 (estimated)
  4. Study completion31 Mar 2033 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07811271
Sponsor's protocol ID
BG-C9074-301
Other IDs
2026-527172-84-00, GOG-3144, ENGOT-ov108, APGOT-OV29
Status last verified
Sep 2026
First submitted
3 Sep 2026
Last updated
10 Sep 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BG-C9074 and Bevacizumab in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by BeOne Medicines.

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 6 inclusion and 7 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 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 BeOne Medicines (1.877.828.5568, clinicaltrials@beonemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free survival (PFS) assessed by Blinded Independent Central Review (BICR) (time frame: Up to 5 years). 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 NCT07811271.

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 Sep 2026.

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