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Triple-Drug cocktail takes on recurrent gynecologic cancers

NCT ID NCT07054567

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase II study tests a combination of three drugs—BL-B01D1, pembrolizumab, and possibly bevacizumab—in people whose cervical or endometrial cancer has come back or spread. The goal is to see if the combo shrinks tumors and to find the best dose. About 96 adults aged 18–75 with recurrent or metastatic disease are being recruited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BL-B01D1 (izalontamab brengitecan), pembrolizumab, and bevacizumab
What this could lead to
If successful, this combination therapy could offer a new treatment option for people with recurrent or metastatic cervical and endometrial cancer.
What could go wrong
This is an early Phase II trial with only 96 participants, so results may not apply to everyone. The drugs can cause side effects, and the combination may not work better than existing treatments.
Why investors are watching

Sichuan Baili Pharmaceutical is running a Phase II trial of its drug BL-B01D1 combined with pembrolizumab, with or without bevacizumab, in 96 patients with recurrent or metastatic cervical and endometrial cancer. For a small publicly traded company, this readout matters because it tests whether the combination can control disease in cancers where current options are limited, and a positive result could validate the drug's potential in a broader market.

If it works: A positive result could show that BL-B01D1 adds meaningful benefit in these cancers, which might support further development and partnerships. It could also strengthen the company's pipeline value beyond its current programs.

If it fails: Trials in advanced cancers often fail to meet their goals, and a negative or unclear result could set back the program and hurt the company's prospects. Delays in enrollment or data readouts could also weigh on the stock.

AI-written from the trial record. Speculative, and not investment advice.

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 96 people

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

Started

Aug 2025

Expected to finish

Dec 2027

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

Anyone

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. The subject voluntarily participates in this study and signs the informed consent form; 2. Age ≥18 years and ≤75 years; 3. Expected survival time ≥3 months; 4. ECOG performance status score of 0-1; 5. Patients with recurrent or metastatic cervical cancer or endometrial cancer confirmed by histopathology and/or cytology; 6. Archived tumor tissue samples from the primary or metastatic lesions within the past 3 years must be provided for PD-L1 and other testing; 7. Must have at least one measurable lesion as defined by RECIST v1.1; 8. Organ function levels must meet the requirements; 9. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0; 10. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, and the serum or urine pregnancy test must be negative. Patients must not be lactating. All enrolled patients must use adequate barrier contraception throughout the treatment period and for 6 months after treatment ends. Exclusion Criteria: 1. Previously received ADC drugs with topoisomerase I inhibitors as the toxin or targeting EGFR and/or HER3; 2. Received chemotherapy, biological therapy, or immunotherapy within 4 weeks or 5 half-lives (whichever is shorter) before the first dose; 3. For Stage II (excluding Cohort 1), subjects who have previously received systemic anti-tumor therapy; 4. Prior immunotherapy resulting in ≥ Grade 3 irAE or ≥ Grade 2 immune-related myocarditis; 5. Used immunomodulatory drugs within 14 days before the first dose of the study drug; 6. Required systemic corticosteroid therapy within 2 weeks before the first dose of the study drug; 7. History of severe cardiovascular or cerebrovascular diseases; 8. Active autoimmune or inflammatory diseases; 9. Other malignancies that progressed or required treatment within 3 years before the first dose; 10. History of ILD/pneumonitis requiring steroid treatment, or current ILD/active pneumonitis; 11. Poorly controlled hypertension (requiring ≥ 2 antihypertensive medications); 12. Poorly controlled diabetes; 13. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; 14. Active central nervous system metastases; 15. Patients with significant serous cavity effusion, symptomatic effusion, or poorly controlled effusion; 16. History of allergy to recombinant humanized antibodies or any excipients of the investigational drug; 17. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT); 18. Positive for HIV antibody, active tuberculosis, active hepatitis B virus (HBV) infection, or active hepatitis C virus (HCV) infection; 19. Active infection requiring systemic treatment; 20. Participation in another clinical trial within 4 weeks before the first dose; 21. Imaging shows tumor invasion or encasement of major abdominal, thoracic, cervical, or pharyngeal blood vessels; 22. Presence of severe unhealed wounds, ulcers, or fractures within 4 weeks before signing informed consent; 23. Clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing informed consent; 24. Planned or received live vaccines within 28 days before randomization; 25. History of severe neurological or psychiatric disorders; 26. Other conditions deemed by the investigator as 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.

  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

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, Shanghai Municipality, China

More trials for these conditions

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