Safety, Tolerability and Pharmacokinetics of TWP-101 in Patients With Advanced Melanoma and Urothelial Carcinoma
NCT04871334 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76
Last updated 2021-07-23
Summary
This study is a multi-center, phase Ia/Ib, open clinical study to evaluate the safety, tolerability and pharmacokinetics of TWP-101 in patients with advanced melanoma and urothelial carcinoma. This study consists of two parts (Part A and Part B). Part A was a dose escalation study, and Part B was a dose expansion study.
Conditions
- Advanced Melanoma
- Advanced Urothelial Carcinoma
Interventions
- DRUG
-
TWP-101
IV infusion Q2W for 4 weeks (28-day cycles)
Sponsors & Collaborators
-
Shandong TheraWisdom Biopharma Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-02-07
- Primary Completion
- 2022-10-31
- Completion
- 2022-12-31
Countries
- China
Study Locations
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