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

NCT05671822 | Recruiting Phase 2

• 1 other identifier: SHR-A1811-Ib/II-205
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (2)

• Phase Ib: Dose limiting toxicity (DLT) rates, Occurrence of adverse events (AEs), and serious adverse events (SAEs)

  Safety will be assessed for approximately 24 months from informed consent

• Phase II: Objective Response Rate (ORR)[

  An average of approximately 12 months

Secondary Outcomes (8)

• ORR（Phase Ib）

  An average of approximately 12 months

• DoR（Phase Ib）

  An average of approximately 18 months

• PFS（Phase Ib）

  An average of approximately 18 months

• OS（Phase Ib）

  An average of approximately 30 months

• DoR（Phase II）

  An average of approximately 18 months

Study Arms (12)

Arm 1A: SHR-A1811 and SHR-1701

EXPERIMENTAL

Drug: SHR-A1811 and SHR-1701

Arm 1B: SHR-A1811 and capecitabine

EXPERIMENTAL

Drug: SHR-A1811 and capecitabine

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

EXPERIMENTAL

Drug: SHR-A181, SHR-1701, and capecitabine

Arm 1D: SHR-A1811, SHR-1316, and capecitabine

EXPERIMENTAL

Drug: SHR-A1811, SHR-1316, and capecitabine

Arm 1F: SHR-A1811, SHR-1316, capecitabine,and oxaliplatin

EXPERIMENTAL

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

Arm 1G: SHR-A1811, SHR-1316, and 5-FU

EXPERIMENTAL

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

Arm 2A: SHR-A1811, SHR-1316, and capecitabine

EXPERIMENTAL

Drug: SHR-A1811, SHR-1316, and capecitabine

Arm 2B: SHR-1316 and SHR-A181

EXPERIMENTAL

Drug: SHR-1316 and SHR-A1811

Arm 2C: SHR-A1811 and capecitabine

EXPERIMENTAL

Drug: SHR-A1811 and capecitabine

Arm 2D: SHR-A1811, SHR-1316, and 5-FU

EXPERIMENTAL

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

Arm 2E: SHR-A1811and 5-FU

EXPERIMENTAL

Drug: SHR-A1811and 5-FU

Arm 2F: SHR-A1811, SHR-1316, capecitabine,and oxaliplatin

EXPERIMENTAL

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

Interventions

SHR-A1811, SHR-1316, and capecitabine DRUG

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

Arm 1D: SHR-A1811, SHR-1316, and capecitabine

SHR-1316 and SHR-A1811 DRUG

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

Arm 2B: SHR-1316 and SHR-A181

SHR-A1811 and capecitabine DRUG

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

Arm 1B: SHR-A1811 and capecitabine

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

(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

Arm 1G: SHR-A1811, SHR-1316, and 5-FU

SHR-A1811and 5-FU DRUG

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

Arm 2E: SHR-A1811and 5-FU

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

(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

Arm 1F: SHR-A1811, SHR-1316, capecitabine,and oxaliplatin

SHR-A1811 and SHR-1701 DRUG

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

Arm 1A: SHR-A1811 and SHR-1701

SHR-A181, SHR-1701, and capecitabine DRUG

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

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 75, Male and female participants
• Local advanced unresectable or metastatic disease Pathologically documented adenocarcinoma of gastric or gastroesophageal junction;
• HER2 expression ;
• Phase Ib: Failed or intolerant to prior standard treatment, or did not receive any systemic anti-tumor therapy; Phase II: previously untreated patients;
• ECOG 0-1;
• The expected survival ≥3 months;
• Sufficient bone marrow and organ functions;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Zhongshan Hospital, FuDan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Interventions

SHR-1701; Capecitabine; Fluorouracil

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Shiwei Sun

CONTACT

+86 18036618554; Shiwei.sun@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 5, 2023
• Study Start: March 14, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 12, 2026

Record last verified: 2025-04

Locations

CN (1)