drugset / Trial / NCT05024305

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

NCT05024305 ↗

Phase 1 Unknown 81 enrolled Shandong TheraWisdom Biopharma Co., Ltd.
RandomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2022-03-08
Primary completion
2022-12-31
Completion
2023-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject TWP-102 injection Unknown — —

Indications