Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2025-12-24 @ 2:39 PM
NCT ID:
NCT07040059
Brief 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.
Detailed Description:
This study (AUR103-201; BHARAT-2) will be conducted in patients with HER2-positive gastric or gastroesophageal (GE) junction adenocarcinoma, in the first-line setting. In the study Part 1 (Phase 1b), the safety and tolerability of AUR103 calcium will be evaluated in combination with Trastuzumab and CAPOX. In the study part 1 (Phase 1b), there will 3 cohorts; Cohort 1 patients will receive the study drug (AUR103 Calcium) at 200 mg BID dose along with standard doses of trastuzumab, and CAPOX (capecitabie and oxaliplatin), Cohort 2 patients will receive the study drug (AUR103 Calcium) at 300 mg BID dose along with standard doses of trastuzumab, and CAPOX, and Cohort 3 patients will receive the study drug (AUR103 Calcium) at 400 mg BID dose along with standard doses of trastuzumab, and CAPOX.
In the study Part 2 (Phase 2), the efficacy of AUR103 calcium in combination with Trastuzumab and CAPOX will be evaluated in HER2-positive gastric or gastroesophageal junction adenocarcinoma patients. The part 2 (Phase 2) of the study will be a randomized study which will start after part 1 (Phase 1b). In the study part 2 (Phase 2), there will either 1 or 2 treatment arm(s) and one control arm (Trastuzumab + CAPOX). The number treatment arms will be based on the phase 1b data. However, the treatment patients in the Phase 2 will receive the study drug along with Trastuzumab and CAPOX.
Study:
NCT07040059
Study Brief:
Protocol Section:
NCT07040059