KD6001 in Combination With Anti-PD-1 Antibody in Patients With Advanced Melanoma

Study Overview
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Brief Summary
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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.

Official Title
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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of KD6001 in Combination With Anti-PD-1 Antibody in Patients With Advanced Melanoma

Conditions
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Melanoma

Intervention / Treatment
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* Drug: KD6001
* Drug: Toripalimab


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Being voluntary to sign the informed consent form. Male or female, aged ≥ 18 years. Patients whose estimated survival time is more than 3 months. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1. Histologically or cytologically confirmed advanced or metastatic melanoma, and the overall proportion of subjects with mucosal malignant melanoma will not exceed 22%. At least one measurable lesion is used as the target lesion according to the Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST V1.1). The results of laboratory examination during the screening period suggest that the subjects have good organ function. Male subjects with reproductive ability or female subjects with the possibility of pregnancy use effective contraceptive methods. Good compliance and follow-up. Main Exclusion Criteria: Systematic treatment with antitumor drugs within 4 weeks prior to the start of this study. Received immunotherapy (including PD-1/PD-L1 therapy and cell therapy) within 4 weeks prior to the start of this study. Prior treatment with anti-CTLA-4 antibody. Subjects with an active, known or suspected autoimmune disease. Subjects with hepatitis (nonalcoholic steatohepatitis, alcoholic or drug-related, autoimmune hepatitis) and liver cirrhosis; active hepatitis B or hepatitis C. Subjects with an active infection requiring systemic treatment. Known history of testing positive for human immunodeficiency virus (HIV). Subjects known to have active tuberculosis (TB). Known to be allergic to KD6001 or Toripalimab and its components.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KD6001+Toripalimab<br>KD6001 combined with toripalimab in patients with advanced melanoma | Drug: KD6001<br>* KD6001 will be administered intravenously.<br>Drug: Toripalimab<br>* Toripalimab will be administered intravenously.<br>* Other names: JS001;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | Baseline to study completion up to 2 years | 
| Maximum tolerated dose (MTD) | The maximum tolerated dose (MTD) of KD6001 combined with toripalimab | Up to Day 21 | 
| Recommended Phase II dose (RP2D) | Recommended Phase 2 dose (RP2D) of KD6001 combined with toripalimab | Up to Day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Baseline to study completion up to 2 years | 
| 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. | Baseline to study completion up to 2 years |