A Study of BL-B01D1 + PD-1 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma

Trial Title: A Study of BL-B01D1 + PD-1 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma

NCT ID: NCT06405425

Condition: Urothelial Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Transitional Cell

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: BL-B01D1
Description: Administration by intravenous infusion for a cycle of 3 weeks.
Arm group label: BL-B01D1 + PD-1

Intervention type: Drug
Intervention name: PD-1
Description: Administration by intravenous infusion for a cycle of 3 weeks.
Arm group label: BL-B01D1 + PD-1

Summary: This study is a phase II clinical study to explore the efficacy and safety of BL-B01D1 + PD-1 combination therapy in patients with locally advanced or metastatic urothelial carcinoma.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. All subjects voluntarily participated in the study and signed informed consent; 2. Male or female aged ≥18 years and ≤75 years; 3. Expected survival time ≥3 months; 4. ECOG 0-1; 5. Unresectable locally advanced or metastatic urothelial carcinoma confirmed by histopathology and/or cytology; 6. Participants should not have received previous systemic therapy for locally advanced or metastatic urothelial cancer; 7. A biopsy sample of archived tumor tissue or metastatic urothelial carcinoma must be available within 3 years for PD-L1 and other testing; 8. At least one measurable lesion meeting the RECIST v1.1 definition was required; 9. The level of organ function must meet the requirements on the premise that blood transfusion and the use of any cell growth factors and/or platelet-raising drugs are not allowed within 14 days before the first dose; 10. Previous treatment-related toxicity returned to ≤ grade 1 defined by NCI-CTCAE v5.0; 11. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, the serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment. Exclusion Criteria: 1. Prior ADC recipients with TOPI inhibitors as toxin; 2. Palliative radiotherapy within 2 weeks before the first dose; 3. Prior immunotherapy with grade ≥3 irAE or grade ≥2 immune-related myocarditis; 4. Use of an immunomodulatory drug within 14 days before the first dose of study drug; 5. The history of severe cardiovascular and cerebrovascular diseases in the past six months was screened; 6. QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia; 7. Active autoimmune and inflammatory diseases; 8. Receiving > before the first dose; Long-term systemic corticosteroid therapy with prednisone 10mg/d; 9. Other malignant tumors that progressed or required treatment within 5 years before the first dose; 10. Presence of: a) poorly controlled diabetes mellitus before starting study treatment; b) severe complications associated with diabetes mellitus; c) a glycated hemoglobin level of 8% or more; d) hypertension poorly controlled by two antihypertensive drugs; e) history of hypertensive crisis or hypertensive encephalopathy; 11. History of ILD, current ILD, or suspected ILD; 12. Complicated with pulmonary diseases leading to clinically severe respiratory impairment; 13. Screening for unstable thrombotic events requiring therapeutic intervention within the preceding 6 months; Infusion-related thrombosis was excluded; 14. Patients with active central nervous system metastases; 15. Patients with massive or symptomatic effusions or poorly controlled effusions; 16. Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or allergic to any excipients of the test drug; 17. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT); 18. HIV antibody positive, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection; 19. Serious infection within 4 weeks before the first dose of study drug; Signs of pulmonary infection or active pulmonary inflammation within 4 weeks; 20. Participated in another clinical trial within 4 weeks before the first dose; 21. Patients with superior vena cava syndrome should not be rehydrated; 22. Have a history of psychotropic substance abuse with an inability to quit or a history of severe neurological or psychiatric illness; 23. Imaging examination showed that the tumor had invaded or wrapped the large thoracic vessels; 24. Severe unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent; 25. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent; 26. Subjects who are scheduled to receive live vaccine or receive live vaccine within 28 days before the first dose; 27. Other circumstances considered by the investigator to be inappropriate for participation in the trial.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Fudan University Shanghai Cancer Center

Address:
City: Shanghai
Country: China

Status: Recruiting

Contact:
Last name: Dingwei Ye

Start date: May 29, 2024

Completion date: May 2026

Lead sponsor:
Agency: Sichuan Baili Pharmaceutical Co., Ltd.
Agency class: Industry

Collaborator:
Agency: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Agency class: Industry

Source: Sichuan Baili Pharmaceutical Co., Ltd.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06405425