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Can a new drug shrink Hard-to-Treat gynecological tumors?

NCT ID NCT07769229

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 126 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Female participants only

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Fujian Cancer Hospital

    Fuzhou, Fujian, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.