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

Primary Purpose

Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ)

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

HLX07+HLX10+oxaliplatin+capecitabine

HLX07

About this trial

This is an interventional treatment trial for Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Gansu Wuwei Tumor HospitalRecruiting
Fudan University shanghai cancer centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm A

Arm B

Arm Description

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

As third-line or above therapy

Outcomes

Primary Outcome Measures

ORR

Objective response rate by IRRC assessment per RECIST 1.1

PFS

Progression-free survival by IRRC assessment per RECIST 1.1

Secondary Outcome Measures

Overall survival

ORR

Objective response rate by INV assessment per RECIST 1.1

PFS

Objective response rate by INV assessment per RECIST 1.1

DOR

Duration of response by IRRC/INV assessment per RECIST 1.1

Full Information

NCT ID

NCT05246982

First Posted

February 16, 2022

Last Updated

April 25, 2022

Sponsor

Shanghai Henlius Biotech

1. Study Identification

Unique Protocol Identification Number

NCT05246982

Brief Title

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

Official Title

An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + Chemotherapy or HLX07 Monotherapy in Patients With Advanced Metastatic Gastric Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 23, 2022 (Actual)

Primary Completion Date

December 20, 2023 (Anticipated)

Study Completion Date

March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Henlius Biotech

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Description

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

Arm Title

Arm B

Arm Type

Experimental

Arm Description

As third-line or above therapy

Intervention Type

Drug

Intervention Name(s)

HLX07+HLX10+oxaliplatin+capecitabine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

HLX07

Intervention Description

HLX07 1500mg q3w

Primary Outcome Measure Information:

Title

ORR

Description

Objective response rate by IRRC assessment per RECIST 1.1

Time Frame

Up to 2 years

Title

PFS

Description

Progression-free survival by IRRC assessment per RECIST 1.1

Time Frame

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

Secondary Outcome Measure Information:

Title

Description

Overall survival

Time Frame

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

Title

ORR

Description

Objective response rate by INV assessment per RECIST 1.1

Time Frame

Up to 2 years

Title

PFS

Description

Objective response rate by INV assessment per RECIST 1.1

Time Frame

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

Title

DOR

Description

Duration of response by IRRC/INV assessment per RECIST 1.1

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dazhi Xu, MD

Phone

021-64175590

xudzh@shca.org.cn

Facility Information:

Facility Name

Gansu Wuwei Tumor Hospital

City

Wuwei

State/Province

Gansu

ZIP/Postal Code

730000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peng Nie, MD

Phone

0935-2268166

nie.peng2008@163.com

Facility Name

Fudan University shanghai cancer center

City

Shanghai

ZIP/Postal Code

200000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dazhi Xu, MD

Phone

021-64175590

xudzh@shca.org.cn

12. IPD Sharing Statement

Learn more about this trial

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

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