A Phase Ib/II Trial to Evaluate the Safety and Efficacy of QL1706 in Patients With Advanced Hepatocellular Carcinoma

Sponsor
Qilu Pharmaceutical Co., Ltd.
Study ID
NCT05603039
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Advanced Liver Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • QL1706 — DRUG
    5 mg/kg#D1#Q3W IV or 7.5 mg/kg#D1#Q3W IV
  • QL1604 — DRUG
    200mg#D1#Q3W IV
  • Bevacizumab — DRUG
    15 mg/kg#D1#Q3W IV or 7.5 mg/kg#D1#Q3W IV

Study Details

This is a phase Ib/II trial to evaluate the safety, pharmacokinetics and preliminary efficacy of QL1706 or QL1604 combined with bevacizumab in patients with advanced hepatocellular carcinoma.

Key Dates

First listed
Nov 2, 2022
Start date
Jul 1, 2021
Status verified
Oct 2022
Primary completion
Dec 30, 2023
Completion
Dec 30, 2023

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: QL1706(5mg/kg)
    QL1706(5mg/kg) Combined with Bevacizumab
  • Experimental: QL1604
    QL1604 Combined with Bevacizumab
  • Experimental: QL1706(7.5mg/kg)
    QL1706(7.5mg/kg) Combined with Bevacizumab

Primary Outcome Measure

Objective remission rate (ORR) [ Time Frame: up to 1year ]

Central Contacts

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