Clinical trial NCT06649292: 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
Official title: An Open, Randomized,Positive Control, Multicenter Phase III Clinical Study of SHR A1904 for Injection Compared With Investigator's Choice of Therapy in Claudin18.2 Positive Patients With Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-10-18
Enrollment: 524
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Overall Survival
timeFrame: Until death, assessed up to approximately 2 years
Secondary outcomes:
measure: Progression-free survival (PFS) by investigator assessment
timeFrame: Until progression or death, assessed up to approximately 1 year
measure: Objective response rate (ORR) by investigator assessment
timeFrame: Until progression, assessed up to approximately 1 year
measure: Duration of response (DOR) by investigator assessment
timeFrame: Until progression or death, assessed up to approximately 1 year
measure: Disease control rate (DCR) by investigator assessment
timeFrame: Until progression, assessed up to approximately 1 year
measure: Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
timeFrame: until to 90 days after the last dose，assessed up to approximately 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References: