ClinicalTrials.gg
Not yet recruitingNCT07811271Updated Sep 10, 2026

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

A Phase 3 interventional study of BG-C9074 and Bevacizumab in Epithelial Ovarian Cancer, Fallopian Tube Cancer and Primary Peritoneal Cancer, sponsored by BeOne Medicines. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by BeOne Medicines · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Epithelial Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer
03

In context

Carcinoma, Ovarian Epithelial

798 studies on the registry are indexed under Carcinoma, Ovarian Epithelial; 102 are open to participants now.

This study's planned enrollment of 600 is above the median of 45 across 585 interventional studies indexed under Carcinoma, Ovarian Epithelial.

Browse Carcinoma, Ovarian Epithelial studies →

Lead sponsor

BeOne Medicines is the lead sponsor of 69 studies on the registry; 49 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Able to provide a signed and dated written prior to any study-specific procedures, sampling, or data collection.
  2. (ECOG) Performance Status ≤ 1.
  3. Participants must have a confirmed diagnosis of epithelial high-grade ovarian, fallopian tube or primary peritoneal carcinoma (serous, endometrioid, or clear cell).
  4. 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.
  5. Participants must have adequate organ function.
  6. Women of must be willing to use a highly effective method of 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.

Exclusion criteria

Exclusion Criteria:

  1. Participants have ovarian, fallopian tube, or peritoneal cancer of nonepithelial origin.
  2. Participants have either a germline or somatic BReast CAncer gene (BRCA) mutation as per local test.
  3. Participants who will receive poly-adenosine diphosphate ribose polymerase (PARP) inhibitor as maintenance therapy per standard of care and investigator discretion.
  4. Participants have a history of allergic reactions or to the active ingredients and of the drug products and other monoclonal antibodies.
  5. Participants had previous , cerebrovascular accident, or subarachnoid hemorrhage within 6 months prior to randomization
  6. Participants have evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation therapy).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
600 participants (estimated)

Study arms

  • Experimental
    Arm A: BG-C9074 + Bevacizumab

    BG-C9074 will be administered first, followed by bevacizumab.

    Drug: BG-C9074 · Drug: Bevacizumab

  • Active comparator
    Arm B: Bevacizumab

    Bevacizumab will be administered alone.

    Drug: Bevacizumab

Interventions

  • DrugBG-C9074

    Administered by Intravenous infusion

  • Administered by Intravenous infusion

06

What researchers measure

Primary outcomes

  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.

    Time frame: Up to 5 years

Secondary outcomes

  1. Overall Survival (OS)

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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: 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).

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Up to 5 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: See plan description

Access criteria: See plan description

Data sharing details ↗ · beonemedicines.com

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Nov 2029, 37 months later.

Of 33 phase 3 interventional studies under Carcinoma, Ovarian Epithelial, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 110. This study's planned 37 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 3, 2026
First posted
Sep 10, 2026
StartEst.
Oct 2026
Primary completionEst.
Nov 30, 2029
CompletionEst.
Mar 31, 2033
Last update
Sep 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07811271
Lead sponsor
BeOne Medicines
Collaborators
GOG Foundation, Latin American Cooperative Oncology Group (LACOG), European Network of Gynaecological Oncological Trial Groups (ENGOT), Asia-Pacific Gynecologic Oncology Trials Group
Responsible party
Sponsor
First posted
Sep 10, 2026
Start date
Oct 2026 (estimated)
Primary completion
Nov 30, 2029 (estimated)
Completion
Mar 31, 2033 (estimated)
Last update
Sep 10, 2026

Study contacts

BeOne Medicines
Contact
clinicaltrials@beonemed.com
1.877.828.5568
Study Director
study director · BeOne Medicines

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion