Can a new drug shrink Hard-to-Treat gynecological tumors?
NCT ID NCT07769229
First seen Aug 17, 2026 · Last updated Aug 27, 2026 · Updated 3 times
Summary
This phase II trial is testing an investigational drug called BL-M09D1 in people with advanced gynecological cancers (such as ovarian, cervical, or endometrial cancer) and other solid tumors that have progressed despite standard treatment. The drug is given by intravenous infusion every three weeks. The study aims to see if the drug can shrink tumors and to evaluate its safety and side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BL-M09D1, an investigational drug given by intravenous infusion
- What this could lead to
- If successful, this could lead to a new treatment option for people with advanced gynecological cancers and other solid tumors that have not responded to standard therapies.
- What could go wrong
- This is an early-phase trial, so the drug may not work as hoped or may cause significant side effects. The results will need confirmation in larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 126 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Voluntarily sign the informed consent form and agree to comply with the protocol requirements; 2. Female; 3. Age: ≥18 years and ≤75 years; 4. Expected survival time ≥3 months; 5. Diagnosed with endometrial cancer, cervical cancer, ovarian cancer, fallopian tube cancer, primary peritoneal carcinoma, or other solid tumors; 6. Patients with locally advanced or metastatic gynecological malignancies and other solid tumors who have failed standard treatment or are intolerant to standard treatment; 7. Agree to provide archived tumor tissue specimens from the primary or metastatic site within 2 years, or fresh tissue samples; 8. Must have at least one measurable lesion as defined by RECIST v1.1; 9. Eastern Cooperative Oncology Group performance status of 0 or 1; 10. Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0; 11. No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%; 12. Organ function levels must meet the protocol requirements; 13. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 × upper limit of normal; 14. Urine protein ≤1+ or ≤1000 mg/24h; 15. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the start of treatment, with serum pregnancy being negative, and they must be non-lactating; all enrolled patients (regardless of male or female) must use adequate barrier contraception throughout the entire treatment period and for 7 months after the end of treatment; 16. The trial participant is capable and willing to comply with the scheduled visits, treatment plan, laboratory tests, and other study-related procedures specified in the protocol. Exclusion Criteria: 1. Use of chemotherapy, targeted therapy, biologic therapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose; 2. History of severe heart disease; 3. Prolonged QT interval, complete left bundle branch block, or third-degree atrioventricular block; 4. Active autoimmune disease or inflammatory disease; 5. Diagnosis of active malignancy within 3 years prior to study randomization; 6. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose; 7. Hypertension inadequately controlled by two antihypertensive agents; 8. Poorly controlled blood glucose; 9. History of interstitial lung disease requiring corticosteroid therapy, or current ILD, or grade ≥2 radiation pneumonitis; 10. Concurrent pulmonary disease resulting in clinically severe impairment of respiratory function; 11. Active central nervous system metastases; 12. History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M09D1; 13. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation; 14. Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection; 15. Active infection requiring systemic therapy within 4 weeks prior to the first study drug administration; 16. Pleural, abdominal, or pericardial effusion requiring drainage and/or accompanied by symptoms within 4 weeks prior to the first study drug administration; 17. Participation in another clinical trial within 4 weeks or 5 half-lives prior to the first dose; 18. Clinically significant bleeding or marked bleeding tendency within 4 weeks prior to the first study drug administration; 19. Inflammatory bowel disease requiring symptomatic or drug intervention, or partial/complete intestinal obstruction within 4 weeks prior to the first study drug administration; 20. Known psychiatric disorders that may affect compliance with the trial; 21. Planned vaccination or administration of live vaccine within 28 days prior to the first dose; 22. Pregnant or breastfeeding women; 23. Other conditions deemed by the investigator to make the participant unsuitable for enrollment in this clinical trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fujian Cancer Hospital
Fuzhou, Fujian, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New PET tracer aims to light up hidden cancer targets
- Can pulsed radiation extend life in metastatic cervical cancer?
- Can inhaled manganese make ovarian cancer immunotherapy hit harder?
- Can a pill shrink Hard-to-Treat ovarian tumors?