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

Phase 1

Recruiting

• Conditions: Melanoma
• Interventions: Drug: KD6001; Drug: Toripalimab

• Registration Number: NCT05723432
• Lead Sponsor: Shanghai Kanda Biotechnology Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-03
• Study First Submitted QC: 2023-02-03
• Study First Posted: 2023-02-10
• Study Start: 2023-03-22
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-04-27
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1. Being voluntary to sign the informed consent form.
2. Male or female, aged ≥ 18 years.
3. Patients whose estimated survival time is more than 3 months.
4. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1.
5. Histologically or cytologically confirmed advanced or metastatic melanoma, and the overall proportion of subjects with mucosal malignant melanoma will not exceed 22%.
6. 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).
7. The results of laboratory examination during the screening period suggest that the subjects have good organ function.
8. Male subjects with reproductive ability or female subjects with the possibility of pregnancy use effective contraceptive methods.
9. Good compliance and follow-up.

Main

Exclusion Criteria

1. Systematic treatment with antitumor drugs within 4 weeks prior to the start of this study.
2. Received immunotherapy (including PD-1/PD-L1 therapy and cell therapy) within 4 weeks prior to the start of this study.
3. Prior treatment with anti-CTLA-4 antibody.
4. Subjects with an active, known or suspected autoimmune disease.
5. Subjects with hepatitis (nonalcoholic steatohepatitis, alcoholic or drug-related, autoimmune hepatitis) and liver cirrhosis; active hepatitis B or hepatitis C.
6. Subjects with an active infection requiring systemic treatment.
7. Known history of testing positive for human immunodeficiency virus (HIV).
8. Subjects known to have active tuberculosis (TB).
9. Known to be allergic to KD6001 or Toripalimab and its components.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KD6001+Toripalimab	KD6001	KD6001 combined with toripalimab in patients with advanced melanoma
KD6001+Toripalimab	Toripalimab	KD6001 combined with toripalimab in patients with advanced melanoma

Primary Outcome Measures

Name	Time	Method
Number of Participants with Dose Limiting Toxicities (DLTs)	Up to Day 21	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.
The incidence and safety profile of participants with adverse events (AEs), serious adverse events(SAE), and immune-related adverse event(irAE)	Baseline to study completion up to 2 years	Evaluate the adverse events (AE) according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 (NCI CTCAE 5.0).
Maximum tolerated dose (MTD)	Up to Day 21	The maximum tolerated dose (MTD) of KD6001 combined with toripalimab
Recommended Phase II dose (RP2D)	Up to Day 21	Recommended Phase 2 dose (RP2D) of KD6001 combined with toripalimab

Secondary Outcome Measures

Name	Time	Method
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	Baseline to study completion up to 2 years	Number of participants with response according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria and modified RECIST 1.1
The PK profile of KD6001 in combination with Toripalimab	Baseline to study completion up to 2 years	Drug concentration of individual subject at different time points after administration; Pharmacokinetic parameters
The immunogenicity of KD6001 in combination with Toripalimab	Baseline to study completion up to 2 years	Including the incidence of ADA positive. For ADA positive patients, the incidence of neutralizing antibody (NAB) will be analyzed.

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, China