Melanoma
Conditions
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.
Interventions
DRUGToripalimab
Toripalimab will be administered intravenously.
DRUGKD6001
KD6001 will be administered intravenously.
Sponsors
Shanghai Kanda Biotechnology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| Maximum tolerated dose (MTD) | Up to Day 21 | The maximum tolerated dose (MTD) of KD6001 combined with toripalimab |
| Recommended Phase II dose (RP2D) | Up to Day 21 | Recommended Phase 2 dose (RP2D) of KD6001 combined with toripalimab |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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 |
Countries
China
Contacts
Primary ContactChi Zhang
Outcome results
None listed