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SHR-A1904 Combinations in CLDN18.2-Positive Advanced Solid Tumor

NCT06350006 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 924

Last updated 2025-12-31

No results posted yet for this study

Summary

This study consists of two research phases:

Phase Ib (includes dose escalation stage and efficacy expansion stage): To explore the safety, tolerability and initial efficacy of SHR-A1904 in the treatment of CLDN18.2-positive advanced solid tumors, and to determine the recommended dose and recommended population for the Phase III combination study.

Phase III: A randomized, Open-Label, multicenter clinical study of SHR-A1904 combined with chemotherapy and immunotherapy Versus chemotherapy combined with immunotherapy for CLDN18.2-positive advanced solid tumors.

Conditions

  • CLDN18.2-positive Advanced Solid Tumor

Interventions

DRUG

SHR-A1904; Adebrelimab

SHR-A1904 combined with Adebrelimab: SHR-A1904+ Adebrelimab

DRUG

SHR-A1904; CAPOX; Adebrelimab

SHR-A1904 combined with Adebrelimab and CAPOX (Capecitabine, Oxaliplatin)

Sponsors & Collaborators

  • Shanghai Hengrui Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-29
Primary Completion
2027-12-30
Completion
2028-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06350006 on ClinicalTrials.gov