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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04871334 on ClinicalTrials.gov