Epithelial Ovarian CancerPhase 3NCT07545460
A Study Comparing BL-M07D1 With Physician's Choice of Chemotherapy in Patients With HER2-Expressing Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer
A Phase 3 study testing BL-M07D1, Liposomal Doxorubicin and Paclitaxel in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with HER2-expressing platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
- What is being tested?
- BL-M07D1, Liposomal Doxorubicin and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 2 sitesChina
- Study dates
- Jul 2026to Dec 2028
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent form and comply with the protocol requirements;
- Be ≥18 years and ≤75 years old on the day of signing the informed consent form;
- Have an expected survival time of ≥3 months;
- Have histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer;
- Have previously received a platinum-based regimen and have been confirmed to have platinum-resistant recurrence;
- Have received a total of ≥1 and ≤3 prior lines of therapy;
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- If previously confirmed to be folate receptor alpha (FRα)-positive, must have received treatment with mirvetuximab soravtansine;
- Agree to provide archived tumor tissue specimens (from primary or metastatic lesions) collected within 3 years, or fresh tissue samples;
- Have at least one measurable lesion as defined by RECIST v1.1;
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Have recovered from toxicities of prior anti-tumor therapy to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
- Have no severe cardiac dysfunction, with a left ventricular ejection fraction (LVEF) ≥50%;
- Meet the required organ function levels;
- For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, with a negative result, and must not be breastfeeding; all enrolled patients must use adequate barrier contraception throughout the entire treatment period and for 6 months after treatment completion.
Who cannot join
- Received surgical treatment, radical radiotherapy, immunotherapy, etc. within 4 weeks before the first dose;
- Previously received ADC therapy with a topoisomerase I inhibitor as the payload, or HER2-ADC therapy;
- History of severe cardiovascular or cerebrovascular disease within six months before screening;
- Concurrent pulmonary disease resulting in severely impaired lung function;
- Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;
- Diagnosed with active malignancy within 3 years before study randomization;
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- Unstable thrombotic event requiring therapeutic intervention within 6 months before screening;
- Hypertension inadequately controlled by two antihypertensive medications;
- Patients with poorly controlled blood glucose levels;
- History of ILD treated with steroids, or current ILD, or Grade ≥2 radiation pneumonitis, etc.;
- Patients with active central nervous system (CNS) metastases;
- Patients with a history of allergy to recombinant humanized antibodies or to any excipient of BL-M07D1;
- Prior receipt of organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Positive for human immunodeficiency virus antibody, active hepatitis B virus infection, or hepatitis C virus infection;
- Experienced severe infection within 4 weeks before the first dose of study drug;
- Presence of large serosal cavity effusions, or symptomatic serosal cavity effusions, etc.;
- Receiving long-term systemic corticosteroid therapy (e.g., >10 mg/day prednisone) prior to randomization;
- History of severe neurological or psychiatric disorders;
- Experienced serious non-healing wound, ulcer, or bone fracture within 4 weeks prior to signing informed consent;
- Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent;
- Intestinal obstruction, Crohn's disease, ulcerative colitis, or chronic diarrhea, etc.;
- Received other unapproved clinical study drugs or treatments within 4 weeks before study randomization;
- Subjects who plan to receive or have received a live vaccine within 28 days before the first dose;
- Presence of other serious physical conditions, abnormal laboratory findings, or poor compliance that may increase the risk of study participation, interfere with study results, or render the patient unsuitable for this study in the investigator's opinion.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Lingying Wu
Yunnan Cancer Hospital
Kunming, Yunnan
Hongying Yang
About this study
Official title: A Phase III Randomized Controlled Clinical Study Comparing BL-M07D1 With Physician's Choice of Chemotherapy in Patients With HER2-Expressing Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer
This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with HER2-expressing platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.
Read the detailed description
In this trial, the treatment group will receive BL-M07D1, while the control group will receive physician's choice of chemotherapy (liposomal doxorubicin, paclitaxel, or topotecan).
- Being tested
- BL-M07D1, Liposomal Doxorubicin, Paclitaxel, Topotecan
- 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.
BL-M07D1Drug
Administration by intravenous infusion for a cycle of 3 weeks.
Liposomal DoxorubicinDrug
Administration by intravenous infusion for a cycle of 4 weeks.
PaclitaxelDrug
Administration by intravenous infusion for a cycle of 4 weeks.
TopotecanDrug
Administration by intravenous infusion for a cycle of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| BL-M07D1 | Experimental | Participants receive BL-M07D1 in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons. Receives: Drug: BL-M07D1 |
| physician's choice of chemotherapy | Active comparator | Participants receive liposomal doxorubicin, paclitaxel or topotecan in the first cycle (4 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons. Receives: Drug: Liposomal Doxorubicin; Drug: Paclitaxel; Drug: Topotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.
Measured: Up to approximately 24 months
Overall survival (OS)
Overall survival (OS) is defined as the time between the subject's randomization date and subject's death.
Measured: Up to approximately 24 months
Secondary outcomes (7)
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).
Measured: Up to approximately 24 months
Disease Control Rate (DCR)
Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.
Measured: Up to approximately 24 months
Duration of Response (DOR)
Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.
Measured: Up to approximately 24 months
Response Rate (RR)
Response Rate (RR) is defined as the proportion of subjects whose overall response is assessed as remission according to the RECIST v1.1 and GCIG CA-125 criteria.
Measured: Up to approximately 24 months
CA-125 Response Rate
CA-125 Response Rate is defined as the proportion of subjects who achieve a response according to the GCIG CA-125 criteria.
Measured: Up to approximately 24 months
Treatment Emergent Adverse Event (TEAE)
TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-M07D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M07D1.
Measured: Up to approximately 24 months
Anti-drug antibody (ADA)
Frequency of anti-BL-M07D1 antibody (ADA) will be investigated.
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study startJul 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Sichuan Baili Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 404 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545460
- Sponsor's protocol ID
- BL-M07D1-308
- Status last verified
- Jun 2026
- First submitted
- 16 Apr 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Controlled Clinical Study Comparing BL-M07D1 With Physician's Choice of Chemotherapy in Patients With HER2-Expressing Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT07545460
- Acronym / sponsor ID
- BL-M07D1-308
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 404 participants (estimated)
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
- Study start
- Jul 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with HER2-expressing platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.
Detailed description
In this trial, the treatment group will receive BL-M07D1, while the control group will receive physician's choice of chemotherapy (liposomal doxorubicin, paclitaxel, or topotecan).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BL-M07D1 | Experimental | Drug: BL-M07D1Participants receive BL-M07D1 in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons. |
| physician's choice of chemotherapy | Active comparator | Drug: Liposomal Doxorubicin, Drug: Paclitaxel, Drug: TopotecanParticipants receive liposomal doxorubicin, paclitaxel or topotecan in the first cycle (4 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Voluntarily sign the informed consent form and comply with the protocol requirements;
- Be ≥18 years and ≤75 years old on the day of signing the informed consent form;
- Have an expected survival time of ≥3 months;
- Have histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer;
- Have previously received a platinum-based regimen and have been confirmed to have platinum-resistant recurrence;
Key exclusion criteria (24 listed)
- Received surgical treatment, radical radiotherapy, immunotherapy, etc. within 4 weeks before the first dose;
- Previously received ADC therapy with a topoisomerase I inhibitor as the payload, or HER2-ADC therapy;
- History of severe cardiovascular or cerebrovascular disease within six months before screening;
- Concurrent pulmonary disease resulting in severely impaired lung function;
- Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BL-M07D1Administration by intravenous infusion for a cycle of 3 weeks. | Drug | BL-M07D1 |
| Liposomal DoxorubicinAdministration by intravenous infusion for a cycle of 4 weeks. | Drug | physician's choice of chemotherapy |
| PaclitaxelAdministration by intravenous infusion for a cycle of 4 weeks. | Drug | physician's choice of chemotherapy |
| TopotecanAdministration by intravenous infusion for a cycle of 4 weeks. | Drug | physician's choice of chemotherapy |
Primary outcome
Progression-free survival (PFS)
Time frame: Up to approximately 24 months
Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.
Overall survival (OS)
Time frame: Up to approximately 24 months
Overall survival (OS) is defined as the time between the subject's randomization date and subject's death.
7 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to approximately 24 months
Disease Control Rate (DCR)
Time frame: Up to approximately 24 months
Duration of Response (DOR)
Time frame: Up to approximately 24 months
Response Rate (RR)
Time frame: Up to approximately 24 months
CA-125 Response Rate
Time frame: Up to approximately 24 months
Treatment Emergent Adverse Event (TEAE)
Time frame: Up to approximately 24 months
Anti-drug antibody (ADA)
Time frame: Up to approximately 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BL-M07D1, Liposomal Doxorubicin and Paclitaxel in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 2 sites in China.
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 14 inclusion and 24 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 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 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 Sa Xiao, PHD (15013238943, xiaosa@baili-pharm.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) (time frame: Up to approximately 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2026.