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Trial Title:
KD6001 in Combination With Anti-PD-1 Antibody in Patients With Advanced Melanoma
NCT ID:
NCT05723432
Condition:
Melanoma
Conditions: Official terms:
Melanoma
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
KD6001
Description:
KD6001 will be administered intravenously.
Arm group label:
KD6001+Toripalimab
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
Toripalimab will be administered intravenously.
Arm group label:
KD6001+Toripalimab
Other name:
JS001
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Guo, MD
Phone:
010-88121122
Email:
guoj307@126.com
Investigator:
Last name:
Jun Guo, MD
Email:
Principal Investigator
Start date:
March 22, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Shanghai Kanda Biotechnology Co., Ltd.
Agency class:
Industry
Source:
Shanghai Kanda Biotechnology Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05723432
