Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2025-12-25 @ 11:13 PM
Study NCT ID:
NCT07040059
Status:
RECRUITING
Last Update Posted:
2025-06-26
First Post:
2025-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Aurigene Discovery Technologies Limited
Organization:
Study Overview
Official Title:
A Phase 1b/2, Open-label, Randomized, Multicenter Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of AUR103 Calcium in Patients With HER2-positive Advanced Gastric/Gastroesophageal Junction Adenocarcinoma (BHARAT-2)
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: