deltatrials
Terminated INTERVENTIONAL 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

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)

Sponsor: Aurigene Discovery Technologies Limited

Conditions Gastroesophageal Junction Adenocarcinoma HER 2 Positive Gastric Cancer
Interventions AUR103 Calcium Trastuzumab + CAPOX (Capecitabine + Oxaliplatin)
Updated 2 times since 2025 Last updated: Apr 14, 2026 Started: Mar 22, 2025 Primary completion: Dec 29, 2025 Completion: Dec 29, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Patient recruitment problems.

Other terminated trials from Aurigene Discovery Technologies Limited

More terminations from Aurigene Discovery Technologies Limited

A observational or N/A phase clinical study on Gastroesophageal Junction Adenocarcinoma and HER 2 Positive Gastric Cancer, this trial is terminated or withdrawn. The trial is conducted by Aurigene Discovery Technologies Limited and has accumulated 2 data snapshots since 2025. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Study Description(click to expand)

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)....

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.

Status Flow

~Jul 2025 – ~Apr 2026 · 10 months · monthly snapshotRecruitingApr 18, 2026 – present · 3 months · daily APITerminated

Change History

2 versions recorded

  1. Apr 18, 2026 — Present [daily]

    Terminated

    Status: Recruiting → Terminated · Phase: PHASE1/PHASE2 → None

  2. Jul 2025 — Apr 2026 [monthly]

    Recruiting PHASE1/PHASE2

    First recorded

Mar 2025

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility 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.

Contact Information

Sponsor contact:
  • Aurigene Discovery Technologies Limited
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations