Can a new drug shrink Hard-to-Treat gynecological tumors?
NCT ID NCT07793825
First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time
Summary
This phase Ib/II trial tests an investigational drug called BL-M08D1 in adults with recurrent or metastatic gynecological cancers and other solid tumors. The study aims to find the safest and most effective dose and to see whether the drug can shrink tumors. Participants receive BL-M08D1 by intravenous infusion every three weeks. The trial will measure how well the drug controls the disease and how long it keeps tumors from growing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BL-M08D1, an investigational drug given by intravenous infusion
- What this could lead to
- If it works, BL-M08D1 could offer a new treatment option for people with recurrent or metastatic gynecological and other solid tumors.
- What could go wrong
- This is an early-phase trial with a small number of participants, so the drug may not prove effective or safe. Possible side effects are not yet fully known.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 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 follow the protocol requirements; 2. Female; 3. Age: ≥18 years and ≤75 years; 4. Expected survival time ≥3 months; 5. Recurrent or metastatic gynecological malignancies and other solid tumors; 6. Agree to provide archived tumor tissue specimens from the primary or metastatic site within 3 years, or fresh tissue samples; 7. Must have at least one measurable lesion as defined by RECIST v1.1; 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 9. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0; 10. No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%; 11. Organ function levels must meet the required criteria; 12. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 × ULN; 13. Urine protein ≤2+ or ≤1000 mg/24h; 14. For premenopausal women of childbearing potential, a serum pregnancy test must be negative within 7 days before starting treatment, and they must not be breastfeeding; all enrolled patients must use adequate barrier contraception throughout the entire treatment period and for 6 months after treatment completion; 15. The trial participant is capable and willing to comply with the visit schedule, treatment plan, laboratory tests, and other study-related procedures as specified in the protocol. Exclusion Criteria: 1. Use of chemotherapy, biotherapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose; 2. History of severe heart disease or cerebrovascular disease within 6 months before screening; 3. Prolonged QT interval, complete left bundle branch block, or third-degree atrioventricular block; 4. Active autoimmune diseases and inflammatory diseases; 5. Diagnosis of another malignancy within 5 years prior to the first dose; 6. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose; 7. Hypertension inadequately controlled by antihypertensive medication; 8. Poorly controlled blood glucose; 9. History of interstitial lung disease requiring corticosteroid therapy, or currently having ILD or grade ≥2 radiation pneumonitis; 10. Severe impairment of respiratory function; 11. Active central nervous system metastases; 12. History of or coexisting central nervous system lesions; 13. History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M08D1; 14. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation; 15. Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection; 16. Active infection requiring systemic therapy within 4 weeks prior to the first dose of the study drug; 17. Pleural, abdominal, or pelvic effusion or pericardial effusion requiring drainage and/or accompanied by symptoms within 4 weeks prior to the first dose of the study drug; 18. Imaging findings indicating tumor invasion or encasement of abdominal, thoracic, or other regions; 19. Use of another investigational drug within 4 weeks or 5 half-lives prior to the first dose; 20. Pregnant or breastfeeding women; 21. Other conditions that, in the investigator's judgment, make the patient unsuitable for participation 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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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
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- Can a new drug tame tumors that resist standard therapy?
- Can a Dual-Action antibody outsmart advanced solid tumors?