RecruitingPhase 2NCT06962787

A Study of BL-B01D1+TKI±Pembrolizumab in Patients With Locally Advanced or Metastatic Renal Cancer

A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 in Combination With Tyrosine Kinase Inhibitor (TKI) With or Without Pembrolizumab (BL-B01D1+TKI±Pembrolizumab) in Patients With Locally Advanced or Metastatic Renal Cancer


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

260 participants

Start Date

Jul 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This Phase II study is a clinical study to explore the efficacy and safety of BL-B01D1 in combination with tyrosine kinase inhibitor (TKI) with or without pembrolizumab (BL-B01D1+TKI±Pembrolizumab) in patients with locally advanced or metastatic renal cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug combination — BL-B01D1 (an antibody-drug conjugate that targets cancer cells) plus a TKI (targeted therapy pill) with or without pembrolizumab (an immunotherapy drug) — for people with locally advanced or metastatic kidney cancer (renal cell carcinoma). The goal is to see how effective and safe this combination is. **You may be eligible if...** - You are between 18 and 75 years old - You have been confirmed by biopsy to have advanced or metastatic kidney cancer (renal cell carcinoma) - You are in good general health (ECOG score 0 or 1) with a life expectancy of at least 3 months - You have at least one measurable tumor on imaging - Your organs are functioning adequately and prior cancer treatment side effects have resolved **You may NOT be eligible if...** - You have active brain metastases - You have another active cancer within the past 5 years - You have had a recent stroke, heart attack, or serious blood clot within 6 months - You have active hepatitis B, hepatitis C, HIV, or tuberculosis - You have autoimmune disease or are on immunosuppressive drugs - You have uncontrolled diabetes or severe lung disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBL-B01D1

Administration by intravenous infusion for a cycle of 3 weeks.

DRUGAxitinib

Oral administration, and twice daily with an interval of 12 hours.

DRUGLenvatinib

Oral administration, and once daily.

DRUGPembrolizumab

Administration by intravenous infusion for a cycle of 3 weeks.


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06962787


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