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

Sponsor
Shanghai Kanda Biotechnology Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05723432
Collaborator
(none)
84
Enrollment
1
Location
1
Arm
33.6
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
84 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Mar 15, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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).

    3. Maximum tolerated dose (MTD) [Up to Day 21]

      The maximum tolerated dose (MTD) of KD6001 combined with toripalimab

    4. Recommended Phase II dose (RP2D) [Up to Day 21]

      Recommended Phase 2 dose (RP2D) of KD6001 combined with toripalimab

    Secondary Outcome Measures

    1. 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

    2. 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

    3. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Cancer Hospital Beijing China

    Sponsors and Collaborators

    • Shanghai Kanda Biotechnology Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shanghai Kanda Biotechnology Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT05723432
    Other Study ID Numbers:
    • KD6001CT02
    First Posted:
    Feb 10, 2023
    Last Update Posted:
    Feb 10, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Melanoma

    Study Results

    No Results Posted as of Feb 10, 2023