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Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2+ Gastric Cancer

Primary Purpose

HER2+ Gastric Cancer/Gastroesophageal Junction Adenocarcinoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR-A1811;SHR-1701;capecitabine;oxaliplatin
SHR-A1811;SHR-1701;capecitabine;oxaliplatin
Sponsored by
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HER2+ Gastric Cancer/Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

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

Inclusion Criteria: Age from 18 to 75 , Male and female participants Local advanced unresectable or metastatic disease Pathologically documented adenocarcinoma of gastric or gastroesophageal junction; HER2 positive; Phase Ib: progression at least one prior Regimen or could not tolerate the standard treatment,pevious anti-HER2 therapy was included Phase II: previously untreated patients ; ECOG 0-1; The expected survival ≥3 months; Sufficient bone marrow and organ functions; Exclusion Criteria: There were ascites, pleural effusion and pericardial effusion that needed to be treated; Major surgery was performed within 4 weeks; Have active autoimmune disease or history of autoimmune disease; Patients with interstitial pneumonia; There was severe infection within 4 weeks before starting the study treatment; Patients with active pulmonary tuberculosis infection history within 1 year before enrollment; Serious cardiovascular and cerebrovascular diseases; Gastrointestinal perforation and/or gastrointestinal fistula occurred within 6 months before enrollment;

Sites / Locations

  • Zhongshan Hospital, FuDan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm 1A: SHR-A1811 and SHR-1701

Arm 1B: SHR-A1811 and capecitabine

Arm 1C: SHR-A181,SHR-1701,and capecitabine

Arm 1D: SHR-A1811,capecitabine,and oxaliplatin

Arm 2A: SHR-A1811 and SHR-1701

Arm 2B: SHR-A181,SHR-1701,and capecitabine

Arm 2C: SHR-A1811,capecitabine,and oxaliplatin

Arm Description

Outcomes

Primary Outcome Measures

Phase Ib: Dose limiting toxicity (DLT) rates, Occurrence of adverse events (AEs), and serious adverse events (SAEs)
Phase II: Objective Response Rate (ORR)[

Secondary Outcome Measures

ORR(Phase Ib)
DoR(Phase Ib)
PFS(Phase Ib)
OS(Phase Ib)
DoR(Phase II)
PFS(Phase II)
OS(Phase II)
Occurrence of adverse events (AEs), and serious adverse events (SAEs) (Phase II)

Full Information

First Posted
January 3, 2023
Last Updated
April 5, 2023
Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05671822
Brief Title
Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2+ Gastric Cancer
Official Title
A Phase Ib/II Study of SHR-A1811 Combinations in Patients With Advanced/Metastatic HER2+ Gastric /Gastroesophageal Junction Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2023 (Actual)
Primary Completion Date
July 30, 2026 (Anticipated)
Study Completion Date
July 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is an open,multicentre phase Ib/II study. The purpose of phase Ib is to evaluated the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of SHR-A1811 in combination with chemotherapy and/or immunotherapy in HER2-positive advanced/metastatic gastric/gastroesophageal junction adenocarcinoma patients. The Phase II study was designed to evaluate the efficacy and safety of SHR-A1811 in combination with chemotherapy and/or immunotherapy for advanced/metastatic HER2-positive gastric/gastroesophageal conjunctional adenocarcinoma patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER2+ Gastric Cancer/Gastroesophageal Junction Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1A: SHR-A1811 and SHR-1701
Arm Type
Experimental
Arm Title
Arm 1B: SHR-A1811 and capecitabine
Arm Type
Experimental
Arm Title
Arm 1C: SHR-A181,SHR-1701,and capecitabine
Arm Type
Experimental
Arm Title
Arm 1D: SHR-A1811,capecitabine,and oxaliplatin
Arm Type
Experimental
Arm Title
Arm 2A: SHR-A1811 and SHR-1701
Arm Type
Experimental
Arm Title
Arm 2B: SHR-A181,SHR-1701,and capecitabine
Arm Type
Experimental
Arm Title
Arm 2C: SHR-A1811,capecitabine,and oxaliplatin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SHR-A1811;SHR-1701;capecitabine;oxaliplatin
Intervention Description
(Arm 1A) Drug: SHR-A1811,administered as an IV infusion Drug: SHR-1701, administered as an IV infusion; (Arm 1B) Drug: SHR-A1811,administered as an IV infusion Drug:capecitabine, administered orally; (Arm 1C) Drug: SHR-A1811,administered as an IV infusion Drug: SHR-1701, administered as an IV infusion Drug:capecitabine, administered orally; (Arm 1D) Drug: SHR-A1811,administered as an IV infusion Drug:capecitabine, administered orally; Drug:oxaliplatin,administered as an IV infusion
Intervention Type
Drug
Intervention Name(s)
SHR-A1811;SHR-1701;capecitabine;oxaliplatin
Intervention Description
(Arm 2A) Drug: SHR-A1811,administered as an IV infusion Drug: SHR-1701, administered as an IV infusion; (Arm 2B) Drug: SHR-A1811,administered as an IV infusion Drug: SHR-1701, administered as an IV infusion Drug:capecitabine, administered orally; (Arm 2C) Drug: SHR-A1811,administered as an IV infusion Drug:capecitabine, administered orally; Drug:oxaliplatin,administered as an IV infusion
Primary Outcome Measure Information:
Title
Phase Ib: Dose limiting toxicity (DLT) rates, Occurrence of adverse events (AEs), and serious adverse events (SAEs)
Time Frame
Safety will be assessed for approximately 24 months from informed consent
Title
Phase II: Objective Response Rate (ORR)[
Time Frame
An average of approximately 12 months
Secondary Outcome Measure Information:
Title
ORR(Phase Ib)
Time Frame
An average of approximately 12 months
Title
DoR(Phase Ib)
Time Frame
An average of approximately 18 months
Title
PFS(Phase Ib)
Time Frame
An average of approximately 18 months
Title
OS(Phase Ib)
Time Frame
An average of approximately 30 months
Title
DoR(Phase II)
Time Frame
An average of approximately 18 months
Title
PFS(Phase II)
Time Frame
An average of approximately 18 months
Title
OS(Phase II)
Time Frame
An average of approximately 30 months
Title
Occurrence of adverse events (AEs), and serious adverse events (SAEs) (Phase II)
Time Frame
Safety will be assessed for approximately 24 months from informed consent]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age from 18 to 75 , Male and female participants Local advanced unresectable or metastatic disease Pathologically documented adenocarcinoma of gastric or gastroesophageal junction; HER2 positive; Phase Ib: progression at least one prior Regimen or could not tolerate the standard treatment,pevious anti-HER2 therapy was included Phase II: previously untreated patients ; ECOG 0-1; The expected survival ≥3 months; Sufficient bone marrow and organ functions; Exclusion Criteria: There were ascites, pleural effusion and pericardial effusion that needed to be treated; Major surgery was performed within 4 weeks; Have active autoimmune disease or history of autoimmune disease; Patients with interstitial pneumonia; There was severe infection within 4 weeks before starting the study treatment; Patients with active pulmonary tuberculosis infection history within 1 year before enrollment; Serious cardiovascular and cerebrovascular diseases; Gastrointestinal perforation and/or gastrointestinal fistula occurred within 6 months before enrollment;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Shi
Phone
+86 13439732857
Email
wei.shi@hengrui.com
Facility Information:
Facility Name
Zhongshan Hospital, FuDan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tianshu Liu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2+ Gastric Cancer

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