Gynecological Malignancies, Solid Tumors
Conditions
Brief 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.
Interventions
DRUGBL-M09D1
Administration by intravenous infusion for a cycle of 3 weeks.
Sponsors
Sichuan Baili Pharmaceutical Co., Ltd.
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase IIa: Recommended Phase II Dose (RP2D) | Up to approximately 24 months | 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. |
| Phase IIa: Treatment-Emergent Adverse Event (TEAE) | Up to approximately 24 months | 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. |
| Phase IIb: Objective Response Rate (ORR) | Up to approximately 24 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase IIa: Objective Response Rate (ORR) | Up to approximately 24 months | 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). |
| Phase IIa/IIb: Progression-free Survival (PFS) | Up to approximately 24 months | 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. |
| Phase IIa/IIb: Disease Control Rate (DCR) | Up to approximately 24 months | 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. |
| Phase IIa/IIb: Duration of Response (DOR) | Up to approximately 24 months | 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. |
| Phase IIb: Treatment-Emergent Adverse Event (TEAE) | Up to approximately 24 months | 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. |
| Cmax | Up to approximately 24 months | Cmax is defined as the maximum observed drug concentration in plasma after administration. |
| Tmax | Up to approximately 24 months | Tmax is defined as the time required to reach the maximum drug concentration in plasma following drug administration. |
| Ctrough | Up to approximately 24 months | Ctrough is defined as the lowest serum concentration prior to the next dose will be administered. |
| Anti-drug Antibody (ADA) | Up to approximately 24 months | Frequency of anti-BL-M09D1 antibody (ADA) will be investigated. |
| Neutralizing Antibody(NAb) | Up to approximately 24 months | Frequency of anti-BL-M09D1 neutralizing antibodies will be investigated. |
Countries
China
Contacts
CONTACTSa Xiao, PHD
Outcome results
None listed