Clinical trial NCT06962787: A Study of BL-B01D1 + Axitinib Without or With Pembrolizumab in Patients With Locally Advanced or Metastatic Renal Cancer
Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1+ Axitinib Without or With Pembrolizumab (BL-B01D1+ Axitinib ± Pembrolizumab) in Patients With Locally Advanced or Metastatic Renal Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Renal Cancer
Lead sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
First posted: 2025-05-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This Phase II study is a clinical study to explore the efficacy and safety of BL-B01D1 + axitinib without or with pembrolizumab (BL-B01D1 + axitinib ± pembrolizumab) in patients with locally advanced or metastatic renal cancer.


Eligibility criteria: Inclusion Criteria:

1. Subject volunteered to participate in the study and signed an informed consent;
2. Male or female aged ≥18 years and ≤75 years;
3. Expected survival time ≥3 months;
4. ECOG score 0 or 1;
5. Patients with locally advanced or metastatic renal cell carcinoma confirmed by histopathology and/or cytology;
6. Agree to provide archived tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 3 years;
7. At least one measurable lesion meeting the RECIST v1.1 definition was required;
8. Organ function level must meet the requirements;
9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
10. Fertile female subjects, or male subjects with fertile partners, must use highly effective contraception from 7 days before the first dose until 7 months after the first dose. Female subjects of childbearing potential had to have a negative serum pregnancy test within 7 days before the first dose.

Exclusion Criteria:

1. Chemotherapy, biological therapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral drugs such as fluorouracil;
2. Prior treatment with an ADC drug containing a camptothecin derivative (topoisomerase I inhibitor) as a toxin;
3. Use of immunomodulatory drugs within 14 days before the first dose of study drug;
4. The history of severe cardiovascular and cerebrovascular diseases within six months before screening;
5. Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
6. Active autoimmune and inflammatory diseases;
7. Systemic corticosteroids or immunosuppressive agents are required within 2 weeks before the first dose;
8. Other malignant tumors within 5 years before the first dose;
9. A history of non-infectious ILD requiring steroid treatment, or current ILD/interstitial pneumonia or suspected ILD;
10. Poorly controlled diabetes before starting study treatment; Severe complications of diabetes mellitus;
11. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
12. Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;
13. Patients with active central nervous system metastasis;
14. Patients with massive or symptomatic effusions or poorly controlled effusions;
15. Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to BL-B01D1 or any excipients of pembrolizumab;
16. Previous history of allogeneic stem cell, bone marrow or organ transplantation;
17. Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;
18. Had a serious infection within 4 weeks before the first dose of study drug; There was pulmonary infection or active pulmonary inflammation at the time of screening;
19. Had participated in another clinical trial within 4 weeks before the first dose (calculated from the time of the last dose);
20. With a history of psychotropic drug abuse and inability to quit or a history of severe neurological or psychiatric illness;
21. Imaging examination showed that the tumor had invaded or wrapped the large thoracic vessels;
22. Serious unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent;
23. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;
24. Subjects scheduled to receive live vaccine or within 28 days before the first dose;
25. Patients with other serious physical and laboratory abnormalities or poor compliance that may increase the risk of participating in the study, or interfere with the results of the study, and patients who were deemed by the investigators to be unsuitable for participation in the study.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 24 months
measure: Recommended Phase II Dose (RP2D)
timeFrame: Up to approximately 24 months
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Up to approximately 24 months
measure: Disease Control Rate (DCR)
timeFrame: Up to approximately 24 months
measure: Duration of Response (DOR)
timeFrame: Up to approximately 24 months
measure: Overall survival (OS)
timeFrame: Up to approximately 24 months
measure: Cmax
timeFrame: Up to approximately 24 months
measure: Tmax
timeFrame: Up to approximately 24 months
measure: Ctrough
timeFrame: Up to approximately 24 months
measure: ADA (anti-drug antibody)
timeFrame: Up to approximately 24 months
measure: Drug-drug Interactions (DDI)
timeFrame: Up to approximately 24 months
measure: Treatment Emergent Adverse Event (TEAE)
timeFrame: Up to approximately 24 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References: