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

NCT05212922 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: YH001004
• Study Type: interventional
• Target: N/A
• Locations: 4 countries
• Sites: 21

Brief 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.

Conditions

HCC; NSCLC Stage IIIB; NSCLC Stage IV

Outcome Measures

Primary Outcomes (1)

• ORR

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

  maximum of 1 years after the first dose of YH001 and Toripalimab study treatment.

Secondary Outcomes (5)

• safety and tolerability

  maximum of 1 years after the first dose of YH001 and Toripalimab study treatment.

• OS

  maximum of 1 years after the first dose of YH001 and Toripalimab study treatment.

• anti-drug antibodies (ADA)

  maximum of 1 years after the first dose of YH001 and Toripalimab study treatment.

• neutralizing antibodies (NAbs).

  maximum of 1 years after the first dose of YH001 and Toripalimab study treatment.

• peak concentration (Cmax)

  maximum of 1 years after the first dose of YH001 and Toripalimab study treatment.

Other Outcomes (5)

• trough concentration (Ctrough)

  maximum of 1 years after the first dose of YH001 and Toripalimab study treatment.

• terminal half-life (T1/2).

  maximum of 1 years after the first dose of YH001 and Toripalimab study treatment.

• Duration of response (DOR)

  maximum of 1 years after the first dose of YH001 and Toripalimab study treatment.

Study Arms (1)

YH001 + Toripalimab

EXPERIMENTAL

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.

Drug: YH001 + Toripalimab

Interventions

YH001 + Toripalimab DRUG

YH001 + Toripalimab

YH001 + Toripalimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged ≥ 18 years；
• Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures.
• Target Population
• Cohort A:
• Have histologically or cytologically confirmed diagnosis of NSCLC (squamous or non-squamous)
• Recurrent or unresectable locally advanced (Stage IIIB) or metastatic (Stage IV);
• Naïve to any systemic anti-cancer therapy
• No EGFR mutation or ALK/ ROS1 gene rearrangement
• PD-L1 positive (TPS≥1%) NSCLC
• Cohort B:
• HCC diagnosis confirmed by or radiology, histology, or cytology;
• Barcelona Clinic Liver Cancer (BCLC) Stage C or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy and not amenable to a curative treatment approach;
• Child-Pugh A liver score within 7 days prior to first dose of study drug;
• Documented objective radiographic progression during or after treatment with sorafenib/lenvatinib, or intolerant of sorafenib/lenvatinib; or documented objective radiographic progression during or after treatment with atezolizumab and bevacizumab, or intolerant of atezolizumab and bevacizumab.
• At least 1 unidimensional measurable target lesion per RECIST v1.1

You may not qualify if:

• Treatment with any investigational drug within 4 weeks prior to the fist dose of study drug；
• Prior anticancer therapy:
• Cohort B: Subjects received sorafenib/lenvatinib within 14 days of first dose of study medication.
• Prior palliative radiotherapy to bone metastases ≤ 2 weeks prior to the first dose of YH001 is acceptable.
• It is unacceptable to have wash out less than 2 weeks for herbal therapy approved for anticancer.
• Subjects with prior anti-CTLA-4 checkpoint inhibitors should be excluded.
• Subjects with a history of ≥ Grade 3 immune-related adverse events resulted from previous immunotherapy or an AE of any grade that resulted in discontinuation of prior immunotherapy
• History of (non-infectious) pneumonitis that required corticosteroids or current pneumonitis, or history of interstitial lung disease
• Subjects requiring systemic treatment with corticosteroids (\>10 mg/day prednisone or equivalent) or other immunosuppressive medications within 21 days before the planned first dose of study drug or has need to be treated while on trial
• Allergic to YH001 and Toripalimab or any component of the study drug formulation.
• Subjects with concomitant active autoimmune disease, history of autoimmune disease requiring systemic treatment, or history of autoimmune disease within the two years prior to study entry.
• Primary central nervous system (CNS) malignancies or symptomatic CNS metastases.
• Subjects with severe cardiovascular diseases, e.g. New York Heart Association (NYHA) Class III or IV heart failure, myocardial infection within 6 months prior to first dose of YH001, uncontrolled hypertension, unstable angina pectoris or unstable cardiac arrhythmia.
• QTcF \> 470 ms at baseline; no concomitant medications that would prolong the QT interval; no family history of long QT syndrome.
• Viral infection:

Sponsors & Collaborators

• Eucure (Beijing) Biopharma Co., Ltd: lead

Study Sites (22)

Gabrail Cancer Center Research

Canton, Ohio, 44718, Armenia

Location

University of New South Wales (UNSW) - Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

Andrew Love Cancer Centre

Geelong, Victoria, 3220, Australia

Location

Coffs Harbour Health Campus

Coffs Harbour, New South Wales, 2450, Austria

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 102218, China

Location

The Affiliated Tumour Hospital of Harbin Medical University

Harbin, Heilongjiang, 150081, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430062, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

Location

Nantong Tumor Hospital

Nantong, Jiangsu, 226361, China

Location

Bethune First Hospital Of Jilin University

Changchun, Jilin, 130021, China

Location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610044, China

Location

Sir Run Run Shaw Hospital Zhejiang University School Of Medicine

Hangzhou, Zhejiang, 310000, China

Location

Kaohsiung Medical University - Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Chi Mei Medical Center - YongKang

Tainan, 71004, Taiwan

Location

Chi Mei Medical Center - Liouying

Tainan, 736, Taiwan

Location

Taipei Medical University Hospital

Taipei, 11031, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

toripalimab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Rong Chen, Ph.D

  Eucure (Beijing) Biopharma Co., Ltd

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group Assignmen

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: January 28, 2022
• Study Start: June 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: March 20, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (7); AU (2); AR (1); CN (11)