Gynecological TumorsPhase 1/2NCT07793825
A Study of BL-M08D1 in Patients With Recurrent or Metastatic Gynecological Malignancies and Other Solid Tumors
A Phase 1/2 study testing BL-M08D1 in people with Gynecological Tumors and Solid Tumors, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This Phase Ib/II study is a clinical study to explore the efficacy and safety of BL-M08D1 for injection in patients with recurrent or metastatic gynecological tumors 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 Tumors, Solid Tumors
- What is being tested?
- BL-M08D1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Dec 2028
- Phase
- Phase 1/2
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 follow the protocol requirements;
- Female;
- Age: ≥18 years and ≤75 years;
- Expected survival time ≥3 months;
- Recurrent or metastatic gynecological malignancies and other solid tumors;
- Agree to provide archived tumor tissue specimens from the primary or metastatic site within 3 years, or fresh tissue samples;
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- Must have at least one measurable lesion as defined by RECIST v1.1;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Toxicities 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 required criteria;
- Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 × ULN;
- Urine protein ≤2+ or ≤1000 mg/24h;
- 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;
- 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.
Who cannot join
- Use of chemotherapy, biotherapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose;
- History of severe heart disease or cerebrovascular disease within 6 months before screening;
- Prolonged QT interval, complete left bundle branch block, or third-degree atrioventricular block;
- Active autoimmune diseases and inflammatory diseases;
- Diagnosis of another malignancy within 5 years prior to the first dose;
- Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;
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- Hypertension inadequately controlled by antihypertensive medication;
- Poorly controlled blood glucose;
- History of interstitial lung disease requiring corticosteroid therapy, or currently having ILD or grade ≥2 radiation pneumonitis;
- Severe impairment of respiratory function;
- Active central nervous system metastases;
- History of or coexisting central nervous system lesions;
- History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M08D1;
- Previous 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 dose of the study drug;
- 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;
- Imaging findings indicating tumor invasion or encasement of abdominal, thoracic, or other regions;
- Use of another investigational drug within 4 weeks or 5 half-lives prior to the first dose;
- Pregnant or breastfeeding women;
- Other conditions that, in the investigator's judgment, make the patient unsuitable for participation 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.
About this study
Official title: A Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M08D1 for Injection in Patients With Recurrent or Metastatic Gynecological Malignancies and Other Solid Tumors
This Phase Ib/II study is a clinical study to explore the efficacy and safety of BL-M08D1 for injection in patients with recurrent or metastatic gynecological tumors and other solid tumors.
- Conditions
- Gynecological Tumors, Solid Tumors
- Being tested
- BL-M08D1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BL-M08D1Drug
Administration by intravenous infusion for a cycle of 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| BL-M08D1 | Experimental | Participants receive BL-M08D1 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-M08D1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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-M08D1.
Measured: Up to approximately 24 months
Objective Response Rate (ORR)
ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.
Measured: Up to approximately 24 months
Secondary outcomes (11)
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
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
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
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-M08D1 . The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M08D1.
Measured: Up to approximately 24 months
Cmax
Cmax is defined as the maximum observed drug concentration in plasma after administration.
Measured: Up to approximately 24 months
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
T1/2
T1/2 is defined as the time required for the plasma concentration of a drug to decrease by 50% during the elimination phase.
Measured: Up to approximately 24 months
AUC0-t
AUC0-t is defined as area under the serum concentration-time curve from time 0 to the time of the last measurable concentration.
Measured: Up to approximately 24 months
CL (Clearance)
Clearance (CL) is the volume of plasma from which a drug is completely removed per unit time.
Measured: Up to approximately 24 months
Ctrough
Ctrough is defined as the lowest serum concentration prior to the next dose will be administered.
Measured: Up to approximately 24 months
Anti-drug Antibody (ADA)
Frequency of anti-BL-M08D1 antibody (ADA) 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.
- First posted31 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecological TumorsStudies of the same condition, open and under way.
- More trials run by Sichuan Baili Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793825
- Sponsor's protocol ID
- BL-M08D1-203
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No