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

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

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 Overview

• Status: Recruiting
• Conditions: Melanoma
• Intervention / Treatment: Drug: KD6001; Drug: Toripalimab

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Main 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KD6001+Toripalimab; KD6001 combined with toripalimab in patients with advanced melanoma	Drug: KD6001; KD6001 will be administered intravenously.; Drug: Toripalimab; Toripalimab will be administered intravenously.; Other Names: JS001

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai Kanda Biotechnology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2023
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: February 3, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (Actual): February 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: KD6001CT02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No