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

NCT05723432 | Unknown Phase 1

• 1 other identifier: KD6001CT02
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• 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

• The PK profile of KD6001 in combination with Toripalimab

  Baseline to study completion up to 2 years

• The immunogenicity of KD6001 in combination with Toripalimab

  Baseline to study completion up to 2 years

Study Arms (1)

KD6001+Toripalimab

EXPERIMENTAL

KD6001 combined with toripalimab in patients with advanced melanoma

Drug: KD6001; Drug: Toripalimab

Interventions

KD6001 DRUG

KD6001 will be administered intravenously.

KD6001+Toripalimab

Toripalimab DRUG

Toripalimab will be administered intravenously.

Also known as: JS001

KD6001+Toripalimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Kanda Biotechnology Co., Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

toripalimab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Chi Zhang

CONTACT

+8615800854907; zhangchi@kandatech.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 10, 2023
• Study Start: March 22, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

CN (1)