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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

NCT07040059 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2026-04-17

No results posted yet for this study

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.

Conditions

  • HER 2 Positive Gastric Cancer
  • Gastroesophageal Junction Adenocarcinoma

Interventions

DRUG

AUR103 Calcium

AUR103 Calcium will be administered with standard dose of Trastuzumab and CAPOX (Capecitabine and oxaliplatin).

DRUG

Trastuzumab + CAPOX (Capecitabine + Oxaliplatin)

Standard dose of Trastuzumab and CAPOX (Capecitabine + Oxaliplatin) will be administered in the Control Arm of Phase 2.

Sponsors & Collaborators

  • Aurigene Discovery Technologies Limited

    lead INDUSTRY

Principal Investigators

  • Akhil Kumar · Aurigene Oncology Limited

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-22
Primary Completion
2025-12-29
Completion
2025-12-29
FDA Drug
Yes

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07040059 on ClinicalTrials.gov