Evaluating BL-B01D1 for patients with multiple solid tumors, including gynecological cancers

A Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-B01D1 for Injection in Patients With Multiple Solid Tumors, Including Recurrent or Metastatic Gynecological Malignancies

This study is testing a new treatment called BL-B01D1 to see if it can safely help patients with multiple solid tumors, especially those with gynecological cancers.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05803018 on ClinicalTrials.gov

What this trial studies

This clinical trial is designed to assess the safety, tolerability, pharmacokinetics, and efficacy of BL-B01D1 in patients suffering from multiple solid tumors, particularly recurrent or metastatic gynecological malignancies. The study is divided into two phases: Phase Ib focuses on exploring the initial efficacy and safety of the treatment, while Phase II aims to evaluate its effectiveness as a single agent in a broader patient population. Participants will be required to provide tumor tissue samples for further analysis, contributing to the understanding of the drug's pharmacokinetic characteristics and immunogenicity.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with recurrent or metastatic gynecological malignancies or other solid tumors that have failed standard treatments.

Not a fit: Patients with solid tumors that are amenable to standard treatment or those who are not able to provide necessary tumor tissue samples may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced gynecological cancers that have not responded to standard therapies.

How similar studies have performed: Other studies have shown promise with similar approaches in treating advanced solid tumors, indicating potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

1. Voluntarily sign the informed consent form and comply with the protocol requirements;
2. Age: ≥18 years and ≤75 years;
3. Expected survival time ≥3 months;
4. Histologically and/or cytologically confirmed recurrent or metastatic gynecological malignancies with failed standard treatment, intolerance to standard treatment, or no current standard treatment available;
5. Agree to provide archived tumor tissue specimens (10 slides) or fresh tissue samples from primary or metastatic lesions within the past 3 years;
6. Must have at least one measurable lesion as defined by RECIST v1.1;
7. ECOG performance status score of 0 or 1;
8. Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
9. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;
10. Organ function levels must meet the requirements without transfusion, albumin, colony-stimulating factors, any cell growth factors, and/or platelet-raising drugs within 14 days before the first dose of the study drug;
11. Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × ULN;
12. Urine protein ≤2+ or ≤1000 mg/24h;
13. For premenopausal women with childbearing potential, a pregnancy test (serum or urine) must be performed within 7 days before starting treatment, and the result must be negative; they must not be breastfeeding. All enrolled patients must use adequate barrier contraception throughout the treatment period and for 6 months after treatment ends.

Exclusion Criteria:

1. Received chemotherapy, biological therapy, immunotherapy, or other antitumor treatments within 4 weeks or 5 half-lives prior to the first dose (6 weeks for mitomycin and nitrosoureas; oral fluorouracil drugs, etc.);
2. History of severe heart disease;
3. Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, or severe arrhythmia;
4. Active autoimmune or inflammatory diseases;
5. Other malignancies with progression or requiring treatment within 5 years prior to the first dose;
6. Poorly controlled hypertension (systolic blood pressure \>150 mmHg or diastolic blood pressure \>100 mmHg) despite the use of two antihypertensive medications;
7. Poorly controlled blood glucose levels;
8. History of interstitial lung disease (ILD), current ILD, or suspected ILD based on imaging during screening;
9. Concurrent pulmonary disease leading to clinically significant respiratory impairment;
10. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
11. Patients with central nervous system (CNS) metastases and/or carcinomatous meningitis (leptomeningeal metastases);
12. Patients with significant serous cavity effusion, symptomatic effusion, or poorly controlled effusion;
13. History of hypersensitivity to recombinant humanized antibodies or human-mouse chimeric antibodies, or any excipients of BL-B01D1;
14. Imaging findings indicating tumor invasion or encasement of major thoracic, cervical, or pharyngeal blood vessels;
15. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
16. Cumulative anthracycline dose \>360 mg/m² in prior (neo)adjuvant anthracycline therapy;
17. Positive for human immunodeficiency virus (HIV) antibodies, active tuberculosis, active hepatitis B virus (HBV) infection, or active hepatitis C virus (HCV) infection;
18. Severe infection within 4 weeks before the first dose of the study drug; signs of active pulmonary infection within 2 weeks before the first dose;
19. Participation in another clinical trial within 4 weeks before the first dose;
20. Any other condition deemed unsuitable for participation in this clinical trial by the investigator.

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University ShangHai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Xiaohua Wu, PHD — Fudan University
• Study coordinator: Sa Xiao, PHD

Conditions Gynecological Malignant Tumor; Solid Tumor; Ovarian Cancer; Endometrial Carcinoma; Cervical Cancer; Tubal carcinoma