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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

March 14, 2023

Primary Completion Date

April 2, 2025

Study Completion Date

July 30, 2026

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

Trial Locations (1)

200032

Zhongshan Hospital, FuDan University, Shanghai

All Listed Sponsors
lead

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

INDUSTRY