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A Phase Ib/Ⅱ Clinical Study to Evaluate the Safety and Efficacy of ANO31905 for Injection in Combination With Chemotherapy as the First-line Treatment for Patients With CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Pancreatic Cancer
The goal of this clinical trial is to assess the safety and efficacy of ANO31905 in combination with chemotherapy as the first-line treatment for subjects with CLDN18.2-positive locally advanced unresectable or metastatic pancreatic cancer.
Details
| Lead sponsor | Anova Innovation Limited |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 84 |
| Start date | 2026-05 |
| Completion | 2028-12 |
Conditions
- Pancreatic Cancer
Interventions
- ANO31905
- ANO31905
- Nanoparticle Albumin-Bound Paclitaxel
- Gemcitabine
Primary outcomes
- Dose-limiting toxicity (DLT) (Phase Ib). — At the end of Cycle 1 (each cycle is 28 days)
The severity of adverse events (AEs) will be graded according to the Common Terminology Criteria for Adverse Events Version 6.0 (the severity of cytokine release syndrome \[CRS\] and immune effector cell-associated neurotoxicity syndrome \[ICANS\] will be graded per the American Society for Transplantation and Cellular Therapy \[ASTCT\] consensus criteria). AEs that occur during the DLT observation period and are judged to be "definitely related", "probably related", or "possibly related" to any investigational products (ANO31905, GEM, Nab-P) will be deemed as a DLT event. - Objective response rate (ORR) assessed by the investigator according to Response Evaluation Criteria for Solid Tumors Version 1.1 (RECIST v1.1) (Phase Ⅱ) — Up to 12 months
Objective response rate (ORR) is defined as the proportion of patients with the best efficacy evaluation of complete response (CR) or partial response (PR) during the study. From date of treatment start until disease progression, date of death or withdrawal from study, whichever came first.