Clinical Trial

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

Terminated Phase 1/2
View on ClinicalTrials.gov →
Why the trial stopped
Patient recruitment problems.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-06-19.
Status change: Recruiting → Terminated 2026-04-14
Trial Details
NCT Number NCT07040059
Lead Sponsor Aurigene Discovery Technologies Limited
Conditions HER 2 Positive Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Enrollment 2 participants
Start Date 2025-03-22
Primary Completion 2025-12-29 (estimated)
Study Completion 2025-12-29 (estimated)
Updated on ClinicalTrials.gov 2026-04-17