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

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 expression 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 expression gastric/gastroesophageal conjunctional adenocarcinoma patients.

Conditions

• HER2 Expression Gastric Cancer/Gastroesophageal Junction Adenocarcinoma

Interventions

DRUG

SHR-A1811 and SHR-1701

(Arm 1A) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1701, administered as an IV infusion;

DRUG

SHR-A1811 and capecitabine

(Arm 1B) Drug: SHR-A1811, administered as an IV infusion Drug：capecitabine, administered orally；

DRUG

SHR-A181, SHR-1701, and capecitabine

(Arm 1C) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1701, administered as an IV infusion Drug：capecitabine, administered orally；

DRUG

SHR-A1811, SHR-1316, and capecitabine

(Arm 1D) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：capecitabine, administered orally；

DRUG

SHR-A1811, SHR-1316, capecitabine,and oxaliplatin

(Arm 1F) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：capecitabine, administered orally； Drug：oxaliplatin，administered as an IV infusion

DRUG

SHR-A1811, SHR-1316, and 5-FU

(Arm 1G) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：5-FU，administered as an IV infusion

DRUG

SHR-A1811, SHR-1316, and capecitabine

(Arm 2A) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316 administered as an IV infusion; Drug：capecitabine, administered orally；

DRUG

SHR-1316 and SHR-A1811

(Arm 2B) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion

DRUG

SHR-A1811 and capecitabine

(Arm 2C) Drug: SHR-A1811, administered as an IV infusion Drug：capecitabine, administered orally；

DRUG

SHR-A1811, SHR-1316, and 5-FU

(Arm 2D) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：5-FU，administered as an IV infusion

DRUG

SHR-A1811and 5-FU

(Arm 2E) Drug: SHR-A1811, administered as an IV infusion Drug：5-FU，administered as an IV infusion

DRUG

SHR-A1811, SHR-1316, capecitabine,and oxaliplatin

(Arm 2F) Drug: SHR-A1811,administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：capecitabine, administered orally； Drug：oxaliplatin，administered as an IV infusion

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-14

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• China

Study Locations