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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
85
KD6001 will be administered intravenously.
Tislelizumab will be administered intravenously.
Bevacizumab will be administered intravenously.
Zhongshan Hospital
Shanghai, China
Number of Participants with Dose Limiting Toxicities (DLTs)
DLTs will be assessed during the dose-escalation phase and are defined as the following treatment-related adverse events occurring within a total of 21 days after the first trial administration.
Time frame: Up to Day 21
The incidence and safety profile of participants with adverse events (AEs), serious adverse events(SAE), and immune-related adverse event(irAE)
Evaluate the adverse events (AE) according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 (NCI CTCAE 5.0).
Time frame: Baseline to study completion up to 2 years
The antitumor activity of KD6001 in combination with Tislelizumab ± Bevacizumab measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Number of participants with response according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
Time frame: Baseline to study completion up to 2 years
Maximum Plasma Concentration [Cmax]
The PK profile of KD6001 in combination with Tislelizumab ± Bevacizumab.
Time frame: Baseline to study completion up to 2 years
Time to reach maximum serum concentration (Tmax)
The PK profile of KD6001 in combination with Tislelizumab ± Bevacizumab.
Time frame: Baseline to study completion up to 2 years
Half-life (T1/2)
The PK profile of KD6001 in combination with Tislelizumab ± Bevacizumab.
Time frame: Baseline to study completion up to 2 years
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Area under blood concentration-time curve(AUC0-T and AUC0-∞)
The PK profile of KD6001 in combination with Tislelizumab ± Bevacizumab.
Time frame: Baseline to study completion up to 2 years
Apparent volume of distribution (Vd)
The PK profile of KD6001 in combination with Tislelizumab ± Bevacizumab.
Time frame: Baseline to study completion up to 2 years
The immunogenicity of KD6001 in combination with Tislelizumab ± Bevacizumab
Including the incidence of ADA positive. For ADA positive patients, the incidence of neutralizing antibody (Nab) will be analyzed.
Time frame: Baseline to study completion up to 2 years