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

Hengrui Medicine

Status and phase: Enrolling; Phase 3

Conditions: Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Treatments: Drug: Paclitaxel, Docetaxel, Irinotecan; Drug: SHR-A1904

Study type: Interventional

Funder types: Industry

Identifiers

NCT06649292

SHR-A1904-302

Details and patient eligibility

About

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

Enrollment: 524 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

524 participants in 2 patient groups

Treatment group A: SHR-A1904

Experimental group

Treatment:

Drug: SHR-A1904

Treatment group B: Paclitaxel, Docetaxel, Irinotecan.

Active Comparator group

Treatment:

Drug: Paclitaxel, Docetaxel, Irinotecan