Status:
UNKNOWN
Safety, Tolerability and Pharmacokinetics of TWP-101 in Patients With Advanced Melanoma and Urothelial Carcinoma
Lead Sponsor:
Shandong TheraWisdom Biopharma Co., Ltd.
Conditions:
Advanced Melanoma
Advanced Urothelial Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 st...
Eligibility Criteria
Inclusion
- Pathologically or cytologically confirmed advanced melanoma or urothelial carcinoma that failed, couldn't tolerate or refused standard treatments
- ECOG score 0 or 1;
- Part B: At least 1 measurable lesion according to RECIST 1.1
Exclusion
- Known hypersensitivity to any ingredient of TWP-101;
- Receiving any anti-cancer drugs;
- History of serious systemic diseases;
- History of serious autoimmune diseases;
- Pregnancy or lactating women.
Key Trial Info
Start Date :
February 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT04871334
Start Date
February 7 2021
End Date
December 31 2022
Last Update
July 23 2021
Active Locations (1)
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1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100142