A Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumours[Substudy 02(BTC&HCC)]

Sponsor
Nanjing Leads Biolabs Co.,Ltd
Study ID
NCT07111546
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumour

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • LBL-024 for Injection — DRUG
    Intravenous infusion.
  • Cisplatin Injection — DRUG
    Intravenous infusion.
  • Gemcitabine Hydrochloride for Injection — DRUG
    Intravenous infusion.
  • Bevacizumab Injection — DRUG
    Intravenous infusion.

Study Details

An open-label, multicenter, phase II clinical study to evaluate the efficacy and safety of LBL-024 in combination with other drugs for the treatment of patients with advanced solid tumour.

Key Dates

First listed
Aug 8, 2025
Start date
Oct 20, 2025
Status verified
May 2026
Primary completion
Dec 26, 2027
Completion
Dec 26, 2027

Study Design

Enrollment
140 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: LBL-024+Gemcitabine Hydrochloride+Cisplatin/LBL-024+Bevacizumab
    Cohort 1： Subjects were treated with LBL-024 combined with gemcitabine and cisplatin Cohort 2： Subjects were treated with LBL-024 combined with Bevacizumab. Intravenous infusion.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy) ]

Central Contacts