Combining KD6001 with an anti-PD-1 antibody for advanced melanoma treatment

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 study is testing if combining a new treatment called KD6001 with an existing drug for advanced melanoma can help patients feel better and improve their response to therapy.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Kanda Biotechnology Co., Ltd. (Industry-sponsored)
• Drugs / interventions: Toripalimab, immunotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT05723432 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of KD6001 in combination with toripalimab, an anti-PD-1 antibody, in patients with advanced melanoma. It is designed as a Phase 1b/2 open-label study, focusing on assessing the pharmacokinetics and initial efficacy of the treatment. Participants will be monitored for tolerability and overall response to the combination therapy. The study aims to gather data that could inform future treatment protocols for advanced melanoma.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed advanced or metastatic melanoma and a good performance status.

Not a fit: Patients who have recently undergone systemic treatment with antitumor drugs may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced melanoma.

How similar studies have performed: Other studies combining immunotherapy with targeted therapies have shown promise, suggesting potential for success in this approach.

Eligibility 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.

Where this trial is running

Beijing

• Beijing Cancer Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Chi Zhang

Conditions Melanoma