SHR-A1904 Compared With Investigator's Choice of Therapy in Claudin18.2 Positive Patitens With Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

NCT06649292 | Recruiting Phase 3

• 1 other identifier: SHR-A1904-302
• Study Type: interventional
• Target: 524
• Locations: 1 country
• Sites: 1

Brief Summary

The study evaluated the overall survival (OS) of SHR-A1904 versus investigator-selected treatment in second-line CLDN18.2-positive advanced GC/GEJC patients

Conditions

Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Measure description: Defined as time from randomization until the date of death due to any cause

  Until death, assessed up to approximately 2 years

Secondary Outcomes (5)

• Progression-free survival (PFS) by investigator assessment

  Until progression or death, assessed up to approximately 1 year

• Objective response rate (ORR) by investigator assessment

  Until progression, assessed up to approximately 1 year

• Duration of response (DOR) by investigator assessment

  Until progression or death, assessed up to approximately 1 year

• Disease control rate (DCR) by investigator assessment

  Until progression, assessed up to approximately 1 year

• Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)

  until to 90 days after the last dose，assessed up to approximately 2 years

Study Arms (2)

Treatment group A: SHR-A1904

EXPERIMENTAL

Drug: SHR-A1904

Treatment group B: Paclitaxel, Docetaxel, Irinotecan.

ACTIVE COMPARATOR

Drug: Paclitaxel, Docetaxel, Irinotecan

Interventions

SHR-A1904 DRUG

SHR-A1904

Treatment group A: SHR-A1904

Paclitaxel, Docetaxel, Irinotecan DRUG

Paclitaxel, Docetaxel, Irinotecan

Treatment group B: Paclitaxel, Docetaxel, Irinotecan.

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 18 to 75 years old (including boundary values)
• Volunteer to participate in this clinical study and sign informed consent;
• ECOG score 0-1;
• Expected survival ≥3 months;
• Gastric or Gastroesophageal Junction Adenocarcinoma;
• positive CLDN18.2 expression in tumor tissue;
• There is at least one measurable or evaluable lesion that meets the RECIST 1.1 criteria;
• Adequate bone marrow and organ function.

You may not qualify if:

• Received anti-tumor therapies such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before the first dose of the study
• HER2 posotive (IHC 3+ or IHC 2+/ISH +);
• Toxicities caused by previous anticancer therapy were not recovered to CTCAE 5.0 Grade≤1;
• Individuals with Leptomeningeal metastasis or Active brain metastases;
• Individuals with a history of GI perforation or fistula, unstable GI bleeding;
• Individuals with a history of severe cardiovascular and cerebrovascular diseases;
• The researcher determined that there are other situations that are not suitable for participation.

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Interventions

Paclitaxel; Docetaxel; Irinotecan

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Camptothecin; Alkaloids; Heterocyclic Compounds

Central Study Contacts

Qi Shi

CONTACT

86-021-23511999; shi.qi.qs16@hengrui.com

Liang Hu

CONTACT

18036618148; Liang.hu@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 18, 2024
• Study Start: November 22, 2024
• Primary Completion (Estimated): September 20, 2027
• Study Completion (Estimated): March 20, 2028
• Last Updated: December 12, 2024

Record last verified: 2024-10

Locations

CN (1)