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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

March 22, 2025

Primary Completion Date

November 30, 2027

Study Completion Date

November 30, 2028

Conditions
HER 2 Positive Gastric CancerGastroesophageal 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.

Trial Locations (8)

380015

RECRUITING

Shalby Hospital, Ahmedabad

380016

RECRUITING

The Gujarat Cancer & Research Insititute, Ahmedabad

395004

NOT_YET_RECRUITING

Kiran Hospital Multi Super Speciality Hospital & Reseach Center, Surat

530040

RECRUITING

HCG Cancer Center, Vizag

560076

RECRUITING

Asha Hospital and Research Centre, Bangalore

560096

RECRUITING

Karnataka Cancer Hospital and Radiation Theraphy Center, Bangalore

700094

RECRUITING

Netaji Subhas Chandra Bose Cancer Hospital, Kolkata

734015

RECRUITING

Hope & Heal Cancer Hospital and Research Center, Siliguri

All Listed Sponsors
lead

Aurigene Discovery Technologies Limited

INDUSTRY