NCT05934331 A LM-302 Combination With Other Anti-Tumor Therapies Phase ll Study
| NCT ID | NCT05934331 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | LaNova Medicines Zhejiang Co., Ltd. |
| Condition | Malignant Neoplasms of Digestive Organs |
| Study Type | INTERVENTIONAL |
| Enrollment | 276 participants |
| Start Date | 2023-07-27 |
| Primary Completion | 2026-07-01 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This study is to evaluate the efficacy of the LM-302 Combination With Other Therapies in patients with CLDN18.2-positive Advanced Digestive Tract Tumor.
Eligibility Criteria
Inclusion Criteria: 1. Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure. 2. Aged 18-80 years old (including boundary values) . 3. Eastern Cooperative Oncology Group (ECOG) performance status of0-1. 4. Life expectancy ≥ 3 months. 5. Subjects with advanced gastrointestinal tumors diagnosed histologically and/or cytologically and who have failed or are intolerant to prior standard first-line therapy (imaging confirmation required) 6. CLDN18.2-positive subjects. 7. At least one measurable lesion. 8. Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose. 9. Subjects who are able to communicate well with investigators and understand and adhere to the requirements of this study. Exclusion Criteria: 1. Subjects with known HER2-positive gastric cancer/adenocarcinoma of the gastroesophageal junction 2. Subjects have participated in any other clinical trial withi