Safety, Tolerability and Pharmacokinetics of TWP-101 in Patients With Advanced Melanoma and Urothelial Carcinoma

Last updated: July 20, 2021
Sponsor: Shandong TheraWisdom Biopharma Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Carcinoma

Metastatic Melanoma

Melanoma

Treatment

N/A

Clinical Study ID

NCT04871334
TWP-101-11
  • Ages 18-75
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pathologically or cytologically confirmed advanced melanoma or urothelial carcinomathat 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

Exclusion Criteria:

  • 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.

Study Design

Total Participants: 76
Study Start date:
February 07, 2021
Estimated Completion Date:
December 31, 2022

Connect with a study center

  • Peking University Cancer Hospital

    Beijing, Beijing 100142
    China

    Active - Recruiting

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