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Bronchial Neoplasms

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Lung Diseases

Respiratory Tract Diseases

This study will include two cohorts of up to 40 subjects each treated with RP2D dose of YH001 in combination with 240 mg Toripalimab to assess the antitumor activity and safety/tolerability.

YH001 + Toripalimab

Rong Chen, Ph.D

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.

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;

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)

To characterize the pharmacokinetic (PK) profiles of YH001 in combination with Toripalimab

To assess other antitumor activity of YH001 in combination with Toripalimab by investigator's assessment according to the RECIST v1.1

Overall Response Rate (ORR) by investigator's assessment according to the RECIST v1.1

The safety and tolerability will be assessed by monitoring the adverse events (AE) per NCI CTCAE v5.0

To assess other antitumor activity of YH001 in combination with Toripalimab

To assess the immunogenicity of YH001 in combination with Toripalimab

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate YH001 in Combination With Toripalimab in Subjects With Advanced NSCLC and HCC	NCT05212922	HCC NSCLC Stage III... NSCLC Stage IV	YH001 + Toripal...	18 Years -	Eucure (Beijing) Biopharma Co., Ltd
A Study to Evaluate YH001 in Combination With Toripalimab in Subjects With Advanced NSCLC and HCC	NCT05212922	HCC NSCLC Stage III... NSCLC Stage IV	YH001 + Toripal...	18 Years -	Eucure (Beijing) Biopharma Co., Ltd
A Study to Evaluate YH001 in Combination With Toripalimab in Subjects With Advanced NSCLC and HCC	NCT05212922	HCC NSCLC Stage III... NSCLC Stage IV	YH001 + Toripal...	18 Years -	Eucure (Beijing) Biopharma Co., Ltd

Spots Global Cancer Trial Database for yh001 + toripalimab