A Study of BL-B01D1 Combined With Lenvatinib in Patients With Advanced Hepatocellular Carcinoma

NCT06986785 | Recruiting Phase 2

• 1 other identifier: BL-B01D1-210
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a clinical study to explore the efficacy and safety of BL-B01D1 combined with lenvatinib in patients with advanced hepatocellular carcinoma.

Conditions

Advanced Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR)

  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).

  Up to approximately 24 months

• Recommended Phase II Dose (RP2D)

  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-B01D1.

  Up to approximately 24 months

Secondary Outcomes (4)

• Progression-free survival (PFS)

  Up to approximately 24 months

• Disease Control Rate (DCR)

  Up to approximately 24 months

• Duration of Response (DOR)

  Up to approximately 24 months

• Treatment Emergent Adverse Event (TEAE)

  Up to approximately 24 months

Study Arms (1)

Study treatment

EXPERIMENTAL

Participants will receive BL-B01D1, and then BL-B01D1+Lenvatinib in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Drug: BL-B01D1; Drug: Lenvatinib

Interventions

BL-B01D1 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Also known as: iza-bren, izalontamab brengitecan, BMS-986507

Study treatment

Lenvatinib DRUG

8mg (body weight \< 60kg), or 12mg (body weight ≥60kg), QD.

Study treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign the informed consent form voluntarily and follow the protocol requirements;
• Gender is not limited;
• Age ≥18 years old and ≤75 years old;
• Expected survival time ≥3 months;
• Patients with advanced HCC confirmed by histology or cytology;
• Consent to provide archived tumor tissue samples or fresh tissue samples from the primary or metastatic lesions;
• At least one measurable lesion meeting the RECIST v1.1 definition was required;
• ECOG score was 0-1;
• The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
• No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
• Organ function level must meet the requirements;
• Coagulation function: international normalized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5×ULN;
• Urinary protein ≤2+ or ≤1000mg/24h;
• No cirrhosis or only Child-Pugh A cirrhosis;
• If hepatitis B virus infection is negative or positive, the status of HBV surface antigen (HBsAg) should be confirmed by HBV serological test;

You may not qualify if:

• Patients with active central nervous system metastases;
• Who had participated in any other clinical trial within 4 weeks before the trial dose;
• Received anti-tumor therapy such as chemotherapy, radiotherapy and biological therapy within 4 weeks before the first use of study drug;
• Had undergone major surgery (investigator-defined) within 4 weeks before the first dose;
• Systemic corticosteroids or immunosuppressive therapy is required within 2 weeks before study dosing;
• Pulmonary disease defined as ≥ grade 3 according to NCI-CTCAE v5.0; A history of ILD/pulmonary inflammation requiring steroid treatment;
• Serious systemic infection within 4 weeks before screening;
• Patients at risk for active autoimmune disease or with a history of autoimmune disease;
• Other malignant tumors within 5 years before the first treatment;
• Human immunodeficiency virus antibody positive, active tuberculosis or hepatitis C virus infection;
• Poorly controlled hypertension by two antihypertensive drugs with different mechanisms;
• Diabetic patients with poor glycemic control;
• Had a history of severe cardiovascular and cerebrovascular diseases;
• Previous history of autologous or allogeneic stem cell, bone marrow or organ transplantation;
• Subjects with clinically significant bleeding or significant bleeding tendency within the previous 4 weeks were screened;

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead
• Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Interventions

lenvatinib

Central Study Contacts

Sa Xiao, PHD

CONTACT

15013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 23, 2025
• Study Start: June 24, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 20, 2025

Record last verified: 2025-08

Locations

CN (1)