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

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong TheraWisdom Biopharma Co., Ltd.

Criteria

Inclusion Criteria:

• Pathologically or cytologically confirmed advanced solid tumor that failed, couldn't tolerate or refused standard treatments;

• ECOG score 0 or 1;

• At least 1 measurable lesion according to RECIST 1.1

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.