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

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05723432
• Other study ID #: KD6001CT02
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 22, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2023
• Source: Shanghai Kanda Biotechnology Co., Ltd.
• Contact: Chi Zhang
• Phone: +8615800854907
• Email: zhangchi[@]kandatech.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• KD6001
KD6001 will be administered intravenously.
• Toripalimab
Toripalimab will be administered intravenously.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Kanda Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Maximum tolerated dose (MTD)	The maximum tolerated dose (MTD) of KD6001 combined with toripalimab	Up to Day 21
Primary	Recommended Phase II dose (RP2D)	Recommended Phase 2 dose (RP2D) of KD6001 combined with toripalimab	Up to Day 21
Secondary	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
Secondary	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
Secondary	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