KD6001 in Combination With Anti-PD-1 Antibody±Bevacizumab in Patients With Advanced HCC and Other Solid Tumors

Sponsor
Shanghai Kanda Biotechnology Co., Ltd.
Study ID
NCT05906524
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Advanced HCC
  • Other Solid Tumors

Eligibility Criteria

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

Interventions

  • KD6001 — DRUG
    KD6001 will be administered intravenously.
  • Tislelizumab — DRUG
    Tislelizumab will be administered intravenously.
  • Bevacizumab — DRUG
    Bevacizumab will be administered intravenously.

Study Details

This is a phase 1b/2, open label study to evaluate the safety, tolerability, pharmacokinetics and initial efficacy of KD6001 in combination with Tislelizumab ± Bevacizumab in patients with Advanced HCC and Other Solid Tumors.

Key Dates

First listed
Jun 18, 2023
Start date
Apr 15, 2024
Status verified
May 2023
Primary completion
Apr 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
85 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1：KD6001+Tislelizumab
    KD6001 combined with Tislelizumab in patients with solid tumors（hepatocellular carcinoma, esophageal squamous cell carcinoma, MSI-H or dMMR solid tumors are preferentially included）
  • Experimental: Phase 2：KD6001+Tislelizumab±Bevacizumab
    KD6001 combined with Tislelizumab±Bevacizumab in patients with advanced HCC

Primary Outcome Measure

Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Up to Day 21 ]

Central Contacts

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