HLX07+HLX10+Chemotherapy or HLX07 Monotherapy in Patients With Advanced Metastatic Gastric Cancer

NCT ID: NCT05246982

Last Updated: 2022-05-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-23
• Study Completion Date: 2024-03-30

Brief Summary

This study is conducted in patients with advanced metastatic gastric cancer including gastroesophageal junction cancer. This study includes two arms: A and B. Arm A (patients with HER2 negative and PD-L1 CPS≥5 ) will receive HLX07 combination therapy with HLX10 and chemotherapy (oxaliplatin+capecitabine) as first-line treatment. Arm B will receive HLX07 monotherapy as third-line or above treatment. All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, HLX10 treatment up to 2 years).

Conditions

Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

HER2 negative and PD-L1 CPS≥5, as first-line therapy

Group Type: EXPERIMENTAL

HLX07+HLX10+oxaliplatin+capecitabine

Intervention Type: DRUG

HLX07 1500mg+HLX10 300mg+oxaliplatin 130mg/m2+capecitabine 1000mg/m2 q3w

Arm B

As third-line or above therapy

Group Type: EXPERIMENTAL

HLX07

Intervention Type: DRUG

HLX07 1500mg q3w

Interventions

HLX07+HLX10+oxaliplatin+capecitabine

HLX07 1500mg+HLX10 300mg+oxaliplatin 130mg/m2+capecitabine 1000mg/m2 q3w

Intervention Type: DRUG

HLX07

HLX07 1500mg q3w

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF); be willing to follow and be able to complete all study procedures;

2. Age ≥ 18 years and ≤ 75 years when ICF is signed;

3. Unresectable locally advanced, or metastatic gastric cancer including gastroesophageal junction cancer, and histopathologically confirmed diagnosis of adenocarcinoma;

4. Arm A: never received systemic anti-tumor drug therapy before, with HER2 negative and PD-L1 CPS≥5; Arm B: failed to prior systemic anti-tumor therapy (at least 2 lines);

5. Measurable lesion according to RECIST v1.1 by IRRC;

6. ECOG score 0-1;

7. Expected survival 12 weeks.

Exclusion Criteria

1. Has other active malignancies within 5 years before the first administration of the study drug;

2. Plan to or have previously received organ or bone marrow transplantation;

3. Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage;

4. Arm A: previously received antibody drugs against immune checkpoints (such as PD-1, PD-L1, CTLA4, etc.) and / or antibody drugs against EGFR; Arm B: previously received antibody drug treatment against EGFR;

5. Have received any research drugs within 14 days before the first use of the study drugs.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Henlius Biotech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gansu Wuwei Tumor Hospital

Wuwei, Gansu, China

Site Status: RECRUITING

Fudan University shanghai cancer center

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Dazhi Xu, MD

Role: CONTACT

xudzh@shca.org.cn

021-64175590

Facility Contacts

Peng Nie, MD

Role: primary

nie.peng2008@163.com

0935-2268166

Dazhi Xu, MD

Role: primary

xudzh@shca.org.cn

021-64175590

Other Identifiers

HLX07-GC201

Identifier Type: -

Identifier Source: org_study_id