Safety, Tolerability, PK, PD, Immunogenicity and Efficacy of TWP-102 in Patients With Advanced Malignancies.

Last updated: March 7, 2022
Sponsor: Shandong TheraWisdom Biopharma Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Advanced Malignancies

Neoplasms

Treatment

N/A

Clinical Study ID

NCT05024305
TWP-102-11
  • Ages 18-75
  • All Genders

Study Summary

This is a multi-center, phase I, open clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and efficacy of TWP-102 injection in patients with advanced malignancies. This study consists of two parts, including a dose escalation study and a dose expansion study. The criteria for dose escalation will be based on the Bayesian optimal interval (BOIN) design with sequentially enrolled cohorts.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pathologically confirmed advanced malignancies that failed, or not suitable forstandard treatments;
  • At least 1 measurable lesion.
  • ECOG score 0 or 1;
  • Life expectancy of ≥ 3 months;

Exclusion

Exclusion Criteria:

  • Known hypersensitivity to any ingredient of TWP-102;
  • Receiving any anti-cancer drugs within 4 weeks;
  • History of serious systemic diseases;
  • History of serious autoimmune diseases;
  • Persistent toxicity of National Cancer Institute (NCI) Common Terminology Criteria forAdverse Events (CTCAE) version 5.0 Grade > 1 severity that is related to prioranti-cancer therapy. (except alopecia)
  • Pregnancy or lactating women.

Study Design

Total Participants: 81
Study Start date:
March 08, 2022
Estimated Completion Date:
June 30, 2023

Connect with a study center

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang 150001
    China

    Active - Recruiting

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