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

NCT05246982 | Unknown Phase 2

• 1 other identifier: HLX07-GC201
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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)

Outcome Measures

Primary Outcomes (2)

• ORR

  Objective response rate by IRRC assessment per RECIST 1.1

  Up to 2 years

• PFS

  Progression-free survival by IRRC assessment per RECIST 1.1

  From the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier), assessed up to 2 years

Secondary Outcomes (4)

• OS

  From the date of first dose unitl the date of death from any cause，assessed up to 2 years

• ORR

  Up to 2 years

• PFS

  From the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier), assessed up to 2 years

• DOR

  From the date when CR or PR (whichever recorded earlier) is firstly achieved until the date when disease progression or death is firstly recorded (whichever occurs earlier),assessed up to 2 years

Study Arms (2)

Arm A

EXPERIMENTAL

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

Drug: HLX07+HLX10+oxaliplatin+capecitabine

Arm B

EXPERIMENTAL

As third-line or above therapy

Drug: HLX07

Interventions

HLX07+HLX10+oxaliplatin+capecitabine DRUG

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

Arm A

HLX07 DRUG

HLX07 1500mg q3w

Arm B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Age ≥ 18 years and ≤ 75 years when ICF is signed;
• Unresectable locally advanced, or metastatic gastric cancer including gastroesophageal junction cancer, and histopathologically confirmed diagnosis of adenocarcinoma;
• 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);
• Measurable lesion according to RECIST v1.1 by IRRC;
• ECOG score 0-1;
• Expected survival 12 weeks.

You may not qualify if:

• Has other active malignancies within 5 years before the first administration of the study drug;
• Plan to or have previously received organ or bone marrow transplantation;
• Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage;
• 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;
• Have received any research drugs within 14 days before the first use of the study drugs.

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (2)

Gansu Wuwei Tumor Hospital

Wuwei, Gansu, 730000, China

RECRUITING

Fudan University shanghai cancer center

Shanghai, 200000, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

HLX07

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Dazhi Xu, MD

CONTACT

021-64175590; xudzh@shca.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: February 18, 2022
• Study Start: March 23, 2022
• Primary Completion: December 20, 2023
• Study Completion: March 30, 2024
• Last Updated: May 2, 2022

Record last verified: 2022-02

Locations

CN (2)