drugset / Trial / NCT07040059
A Phase 1b/2 Clinical Trial Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of AUR103 Calcium in Patients With HER2-positive Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The study will have a dose escalation part (Phase 1b) and a randomized part (Phase 2). In Phase 1b, patients diagnosed with advanced HER2 positive gastric/gastroesophageal adenocarcinoma will be enrolled in a 3 + 3 design dose escalation manner to evaluate the safety, efficacy, PK/PD of AUR103 Calcium when administered in combination with Trastuzumab and CAPOX (capecitabine and oxaliplatin). Phase 2 is a randomization study. The primary objective of the phase 2 study is to assess the efficacy of AUR103 Calcium when administered in combination with Trastuzumab and CAPOX (capecitabine and oxaliplatin). The phase 2 of the study will be conducted after Phase 1b.
Timeline
- Start
- 2025-03-22
- Primary completion
- 2025-12-29
- Completion
- 2025-12-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AUR103 | Unknown | 200 mg | — |
| Subject | AUR103 | Unknown | 300 mg | — |
| Subject | AUR103 | Unknown | 400 mg | — |
| Comparator | Capecitabine | Small molecule | — | — |
| Comparator | Oxaliplatin | Small molecule | — | — |
| Comparator | Trastuzumab | Monoclonal antibody | — | — |