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

Phase 2RecruitingNCT05671822

Suzhou Suncadia Biopharmaceuticals Co., Ltd.258 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

258

Conditions

HER2 Expression Gastric Cancer/Gastroesophageal Junction Adenocarcinoma

Interventions

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

SHR-A1811 and capecitabineDRUG

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

SHR-A181, SHR-1701, and capecitabineDRUG

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

SHR-A1811, SHR-1316, and capecitabineDRUG

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

SHR-A1811, SHR-1316, capecitabine,and oxaliplatinDRUG

(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

SHR-A1811, SHR-1316, and 5-FUDRUG

(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

SHR-A1811, SHR-1316, and capecitabineDRUG

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

SHR-1316 and SHR-A1811DRUG

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

SHR-A1811 and capecitabineDRUG

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

SHR-A1811, SHR-1316, and 5-FUDRUG

(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

SHR-A1811and 5-FUDRUG

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

SHR-A1811, SHR-1316, capecitabine,and oxaliplatinDRUG

(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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age from 18 to 75, Male and female participants 2. Local advanced unresectable or metastatic disease Pathologically documented adenocarcinoma of gastric or gastroesophageal junction; 3. HER2 expression ; 4. Phase Ib: Failed or intolerant to prior standard treatment, or did not receive any systemic anti-tumor therapy; Phase II: previously untreated patients; 5. ECOG 0-1; 6. The expected survival ≥3 months; 7. Sufficient bone marrow and organ functions; Exclusion Criteria: 1. There were ascites, pleural effusion and pericardial effusion that needed to be treated; 2. Major surgery was performed within 4 weeks; 3. Have active autoimmune disease or history of autoimmune disease; 4. Patients with interstitial pneumonia; 5. There was severe infection within 4 weeks before starting the study treatment; 6. Patients with active pulmonary tuberculosis infection history within 1 year before enrollment; 7. Serious cardiovascular and cerebrovascular diseases; 8. Gastrointestinal perforation and/or gastrointestinal fistula occurred within 6 months before enrollment;

Locations (1)

Zhongshan Hospital, FuDan University

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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

Phase II: Objective Response Rate (ORR)[

Time frame: An average of approximately 12 months

Secondary Outcomes

ORR（Phase Ib）

Time frame: An average of approximately 12 months

DoR（Phase Ib）

Time frame: An average of approximately 18 months

PFS（Phase Ib）

Time frame: An average of approximately 18 months

OS（Phase Ib）

Time frame: An average of approximately 30 months

DoR（Phase II）

Time frame: An average of approximately 18 months

PFS（Phase II）

Time frame: An average of approximately 18 months

OS（Phase II）

Time frame: An average of approximately 30 months

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]

Central Contacts

Shiwei Sun

CONTACT

+86 18036618554 Shiwei.sun@hengrui.com

Data from ClinicalTrials.gov

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