The Safety and Efficacy of TWP-101 in Patients With Advanced Solid Tumor

Last updated: July 20, 2021
Sponsor: Shandong TheraWisdom Biopharma Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

1

Condition

Neoplasms

Treatment

N/A

Clinical Study ID

NCT04871347
TWP-101-12
  • Ages 18-75
  • All Genders

Study Summary

This is a multi-center, phase Ia/Ib, open clinical study to evaluate the safety and efficacy of TWP-101 in patients with advanced solid tumor. 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 solid tumor that failed, couldn'ttolerate or refused standard treatments;
  • ECOG score 0 or 1;
  • 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 within 4 weeks;
  • History of serious systemic diseases;
  • History of serious autoimmune diseases;
  • Pregnancy or lactating women.

Study Design

Total Participants: 58
Study Start date:
August 30, 2021
Estimated Completion Date:
December 31, 2023

Connect with a study center

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang 150001
    China

    Site Not Available

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