This is a phase 1b/2, open label study to evaluate the safety, tolerability, pharmacokinetics and initial efficacy of KD6001 in combination with toripalimab in patients with advanced melanoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
84
KD6001 will be administered intravenously.
Toripalimab will be administered intravenously.
Beijing Cancer Hospital
Beijing, China
RECRUITINGNumber 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
Maximum tolerated dose (MTD)
The maximum tolerated dose (MTD) of KD6001 combined with toripalimab
Time frame: Up to Day 21
Recommended Phase II dose (RP2D)
Recommended Phase 2 dose (RP2D) of KD6001 combined with toripalimab
Time frame: Up to Day 21
The antitumor activity of KD6001 in combination with Toripalimab measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and modified RECIST 1.1
Number of participants with response according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria and modified RECIST 1.1
Time frame: Baseline to study completion up to 2 years
The PK profile of KD6001 in combination with Toripalimab
Drug concentration of individual subject at different time points after administration; Pharmacokinetic parameters
Time frame: Baseline to study completion up to 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The immunogenicity of KD6001 in combination with Toripalimab
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