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Gynecological MalignanciesPhase 2NCT07769229

A Study of BL-M09D1 in Patients With Locally Advanced or Metastatic Gynecological Malignancies and Other Solid Tumors

A Phase 2 study testing BL-M09D1 in people with Gynecological Malignancies and Solid Tumors, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study is a single-arm, open-label, multicenter, non-randomized phase II clinical study evaluating the efficacy and safety of BL-M09D1 for injection in patients with locally advanced or metastatic gynecological malignancies and other solid tumors. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Gynecological Malignancies, Solid Tumors
What is being tested?
BL-M09D1
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
1 siteChina
Study dates
Aug 2026to Dec 2028
Phase
Phase 2
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily sign the informed consent form and agree to comply with the protocol requirements;
  • Female;
  • Age: ≥18 years and ≤75 years;
  • Expected survival time ≥3 months;
  • Diagnosed with endometrial cancer, cervical cancer, ovarian cancer, fallopian tube cancer, primary peritoneal carcinoma, or other solid tumors;
  • Patients with locally advanced or metastatic gynecological malignancies and other solid tumors who have failed standard treatment or are intolerant to standard treatment;
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  • Agree to provide archived tumor tissue specimens from the primary or metastatic site within 2 years, or fresh tissue samples;
  • Must have at least one measurable lesion as defined by RECIST v1.1;
  • Eastern Cooperative Oncology Group performance status of 0 or 1;
  • Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
  • No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;
  • Organ function levels must meet the protocol requirements;
  • Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 × upper limit of normal;
  • Urine protein ≤1+ or ≤1000 mg/24h;
  • 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;
  • 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.

Who cannot join

  • Use of chemotherapy, targeted therapy, biologic therapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose;
  • History of severe heart disease;
  • Prolonged QT interval, complete left bundle branch block, or third-degree atrioventricular block;
  • Active autoimmune disease or inflammatory disease;
  • Diagnosis of active malignancy within 3 years prior to study randomization;
  • Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;
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  • Hypertension inadequately controlled by two antihypertensive agents;
  • Poorly controlled blood glucose;
  • History of interstitial lung disease requiring corticosteroid therapy, or current ILD, or grade ≥2 radiation pneumonitis;
  • Concurrent pulmonary disease resulting in clinically severe impairment of respiratory function;
  • Active central nervous system metastases;
  • History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M09D1;
  • Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
  • Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
  • Active infection requiring systemic therapy within 4 weeks prior to the first study drug administration;
  • Pleural, abdominal, or pericardial effusion requiring drainage and/or accompanied by symptoms within 4 weeks prior to the first study drug administration;
  • Participation in another clinical trial within 4 weeks or 5 half-lives prior to the first dose;
  • Clinically significant bleeding or marked bleeding tendency within 4 weeks prior to the first study drug administration;
  • Inflammatory bowel disease requiring symptomatic or drug intervention, or partial/complete intestinal obstruction within 4 weeks prior to the first study drug administration;
  • Known psychiatric disorders that may affect compliance with the trial;
  • Planned vaccination or administration of live vaccine within 28 days prior to the first dose;
  • Pregnant or breastfeeding women;
  • Other conditions deemed by the investigator to make the participant unsuitable for enrollment in this clinical trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sa Xiao, PHD contact

+8615013238943

xiaosa@baili-pharm.com

China1 site

  • Fujian Cancer Hospital

    Fuzhou, Fujian

    Yang Sun

Other trials in China

About this study

Official title: A Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M09D1 for Injection in Patients With Locally Advanced or Metastatic Gynecological Malignancies and Other Solid Tumors

This study is a single-arm, open-label, multicenter, non-randomized phase II clinical study evaluating the efficacy and safety of BL-M09D1 for injection in patients with locally advanced or metastatic gynecological malignancies and other solid tumors.

Being tested
BL-M09D1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BL-M09D1Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

Study groups in NCT07769229
Study groupRoleWhat they receive
BL-M09D1ExperimentalParticipants receive BL-M09D1 for 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-M09D1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase IIa: Recommended Phase II Dose (RP2D)

    The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-M09D1.

    Measured: Up to approximately 24 months

  2. Phase IIa: 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-M09D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M09D1.

    Measured: Up to approximately 24 months

  3. Phase IIb: 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

Secondary outcomes (10)

  1. Phase IIa: 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

  2. Phase IIa/IIb: 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

  3. Phase IIa/IIb: 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

  4. Phase IIa/IIb: Duration of Response (DOR)

    Duration of Response (DOR) is 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

  5. Phase IIb: 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-M09D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M09D1.

    Measured: Up to approximately 24 months

  6. Cmax

    Cmax is defined as the maximum observed drug concentration in plasma after administration.

    Measured: Up to approximately 24 months

  7. Tmax

    Tmax is defined as the time required to reach the maximum drug concentration in plasma following drug administration.

    Measured: Up to approximately 24 months

  8. Ctrough

    Ctrough is defined as the lowest serum concentration prior to the next dose will be administered.

    Measured: Up to approximately 24 months

  9. Anti-drug Antibody (ADA)

    Frequency of anti-BL-M09D1 antibody (ADA) will be investigated.

    Measured: Up to approximately 24 months

  10. Neutralizing Antibody(NAb)

    Frequency of anti-BL-M09D1 neutralizing antibodies 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.

  1. First posted17 Aug 2026
  2. Study startAug 2026 (estimated)
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
126 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07769229
Sponsor's protocol ID
BL-M09D1-201
Status last verified
Aug 2026
First submitted
12 Aug 2026
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BL-M09D1 in people with Gynecological Malignancies and Solid Tumors, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site 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 16 inclusion and 23 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 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 (+8615013238943, xiaosa@baili-pharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase IIa: Recommended Phase II Dose (RP2D) (time frame: Up to approximately 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07769229.

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 26 Aug 2026.

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