NCT05212922

A Study to Evaluate YH001 in Combination With Toripalimab in Subjects With Advanced NSCLC and HCC

An Open-Label, Non-Randomized, Multi-center Phase 2 Study of YH001 in Combination With Toripalimab in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC) and Hepatocellular Carcinoma (HCC)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Eucure (Beijing) Biopharma Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an Open-label, Non-Randomized, Multi-center Phase 2 study of YH001 in Combination with Toripalimab，The study is designed to determine the safety ，tolerability and antitumor activity of YH001 in combination with Toripalimab in subjects with advanced NSCLC and HCC.

Detailed description

This study will include two cohorts of up to 40 subjects each treated with RP2D dose YH001 in combination with 240 mg Toripalimab to assess the antitumor activity and safety/tolerability. According to Simon's two stage design, in the first stage, 9-10 subjects will be accrued. If there are ≤ 1 subjects achieving an objective response, the futility stop will be called. Enrollment will start for the second stage after Stage 1 data pass futility test. In the second stage, 17-19 subjects will be enrolled to have 27 subjects in total. If there are ≥ 5 subjects achieving an objective response, a stop could be called for meeting the primary objective. In all cohorts, 4 mg/kg or other higher dose level of YH001 (not exceeding MTD) may be needed based on the safety data in the first stage. * Cohort A: YH001 in combination with Toripalimab in subjects with advanced PD-L1 positive NSCLC as 1st line treatment; * Cohort B: YH001 in combination with Toripalimab in subjects with previously systemically treated advanced HCC as 2nd line treatment;

Conditions

• HCC
• NSCLC Stage IIIB
• NSCLC Stage IV

Interventions

Type	Name	Description
DRUG	YH001 + Toripalimab	YH001 + Toripalimab

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-12-01
• Completion: 2025-03-01
• First posted: 2022-01-28
• Last updated: 2023-03-20

Locations

22 sites across 5 countries: Armenia, Australia, Austria, China, Taiwan

Regulatory

• FDA-regulated drug study