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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05723432
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Shanghai Kanda Biotechnology Co., Ltd.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Melanoma

Arms & Interventions

Arms

Experimental: KD6001+Toripalimab

KD6001 combined with toripalimab in patients with advanced melanoma

Interventions

Drug: - KD6001

KD6001 will be administered intravenously.

Drug: - Toripalimab

Toripalimab will be administered intravenously.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing Cancer Hospital, Beijing, China

Status

Recruiting

Address

Beijing Cancer Hospital

Beijing, ,

Site Contact

Jun Guo, MD

[email protected]

010-88121122

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