Trials / Unknown
UnknownNCT04871334
Safety, Tolerability and Pharmacokinetics of TWP-101 in Patients With Advanced Melanoma and Urothelial Carcinoma
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
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 76 (estimated)
- Sponsor
- Shandong TheraWisdom Biopharma Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TWP-101 | IV infusion Q2W for 4 weeks (28-day cycles) |
Timeline
- Start date
- 2021-02-07
- Primary completion
- 2022-10-31
- Completion
- 2022-12-31
- First posted
- 2021-05-04
- Last updated
- 2021-07-23
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04871334. Inclusion in this directory is not an endorsement.