Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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)

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) is a Phase 1 / Phase 2 interventional studying HER 2 Positive Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, sponsored by Aurigene Discovery Technologies Limited. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For HER 2 Positive Gastric Cancer, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 18 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Provide signed and dated willing to sign a consent form and agree to comply with all study related activities. 2. Male or female patients aged greater than or equal to 18 years. 3. Patients must meet the following criteria for each of the respective parts of the study: a) Pathological diagnosis of a HER2-positive, unresectable locally advanced or metastatic, gastric / gastroesophageal (GE) junction adenocarcinoma. \[Note: For patients who have already undergone HER2 testing, it does not need to be repeated. For patients who have not undergone HER2 testing, the same can be done as part of pre-screening, after taking willing to sign a consent form\]. B) Patients must NOT have received any systemic anti-cancer therapy for the treatment of gastric or gastroesophageal (GE) junction adenocarcinoma. \[Note: The partial resection of tumor or debulking surgery is allowed but any therapeutic chemotherapy or systemic anti-cancer therapy is not allowed\]. 4. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1. 5. Acceptable bone marrow as described below: 1. ANC greater than or equal to 1500/μL (without WBC growth factor support). 2. Platelet count greater than or equal to 100,000/μL (without transfusion support). 3. Hemoglobin greater than or equal to 9 g/dL (Transfusion is allowed to achieve this Hb). 6. Acceptable organ function as described below: 1. Total Bilirubin less than or equal to 1.5 x ULN (Patients with known Gilbert's syndrome are allowed with a Total Bilirubin less than or equal to 2.5 x ULN). 2. AST (SGOT) less than or equal to 3 x ULN (less than or equal to 5 × ULN if known liver metastases). 3. ALT (SGPT) less than or equal to 3 x ULN (less than or equal to 5 × ULN if known liver metastases). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Provide signed and dated informed consent and agree to comply with all study related activities. 2. Male or female patients aged greater than or equal to 18 years. 3. Patients must meet the following criteria for each of the respective parts of the study: a) Pathological diagnosis of a HER2-positive, unresectable locally advanced or metastatic, gastric / gastroesophageal (GE) junction adenocarcinoma. \[Note: For patients who have already undergone HER2 testing, it does not need to be repeated. For patients who have not undergone HER2 testing, the same can be done as part of pre-screening, after taking informed consent\]. B) Patients must NOT have received any systemic anti-cancer therapy for the treatment of gastric or gastroesophageal (GE) junction adenocarcinoma. \[Note: The partial resection of tumor or debulking surgery is allowed but any therapeutic chemotherapy or systemic anti-cancer therapy is not allowed\]. 4. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1. 5. Acceptable bone marrow as described below: 1. ANC greater than or equal to 1500/μL (without WBC growth factor support). 2. Platelet count greater than or equal to 100,000/μL (without transfusion support). 3. Hemoglobin greater than or equal to 9 g/dL (Transfusion is allowed to achieve this Hb). 6. Acceptable organ function as described below: 1. Total Bilirubin less than or equal to 1.5 x ULN (Patients with known Gilbert's syndrome are allowed with a Total Bilirubin less than or equal to 2.5 x ULN). 2. AST (SGOT) less than or equal to 3 x ULN (less than or equal to 5 × ULN if known liver metastases). 3. ALT (SGPT) less than or equal to 3 x ULN (less than or equal to 5 × ULN if known liver metastases). 4. Creatinine clearance (CrCl) greater than or equal to 60 mL/min (either measured or estimated by the Cockcroft-Gault formula). (Cockcroft-Gault formula for estimated creatinine clearance \[eCrCl\]: eCrCl = \[140 - Age\] × Weight \[kg\] × \[0.85 if Female\] / \[72 × serum creatinine (mg/dL)\]). 5. Albumin greater than or equal to 3.0 g/dL. 7. Evidence of measurable disease as per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 \[Note: Measurable disease for solid tumors is defined as at least one lesion that can be accurately measured in at least 1 dimension with a minimum size of 10 mm for non-nodal lesions or 15 mm in short axis for nodal lesions\]. 8. Patients who have not undergone HER2 testing must be willing and able to provide an adequate archived tumor tissue sample or a fresh tumor tissue sample to confirm HER2 status. \[Note: If archived sample is not available, and HER2 testing has not been done, then patient must agree to submit fresh tumor sample for an assessment of HER2 status\]. 9. Left ventricular ejection fraction (LVEF) greater than or equal to 50% by either echocardiogram (ECHO) or multigated acquisition (MUGA) scan at Screening. 10. Ability to swallow and retain oral medications. 11. Negative serum pregnancy test in women of childbearing potential (WOCBP). 12. Women of childbearing potential and men who partner with such a woman of childbearing potential must agree to use one or more of highly effective method(s) for contraception for the duration of the study, i.e., through 28-day follow up visit, after discontinuation of study drug(s). Exclusion Criteria: 1. Patients with resectable gastric / gastroesophageal (GE) junction adenocarcinoma. 2. Exposed to definitive radiotherapy \[Note: Palliative radiotherapy is allowed\]. 3. Use of any investigational agent within 28 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1. 4. Known central nervous system (CNS) metastases. 5. Major surgery less than or equal to 28 days from Cycle 1 Day 1 (Major surgery is defined as a procedure requiring general anaesthesia). 6. Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome-related illness. 7. Known active or chronic hepatitis B or hepatitis C infection. 8. Uncontrolled congestive heart failure (New York Heart Association \[NYHA\] Class 2-4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, or transient ischemic attack, or pulmonary embolism within 3 months prior to Cycle 1 Day 1. 9. Ongoing cardiac dysrhythmias requiring treatment of any grade or treatment of cardiac dysrhythmias in past 3 months, before Cycle 1 Day 1. 10. The QTcF (corrected QT interval Fridericia method) value in the screening ECG more than 460 ms in males and females. 11. Currently taking warfarin or other oral coumarin-derivative anticoagulant therapy. 12. Patients with peripheral neuropathy of Grade greater than or equal to 2. 13. Patients with severe obstructive pulmonary disease, pulmonary fibrosis, or interstitial lung disease. 14. Patients with poorly controlled hypertension, defined as systolic blood pressure more than or equal to 160 mmHg or diastolic blood pressure more than 100 mmHg. 15. Previous or concomitant additional malignancy, except for basal cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the uterine cervix; patients with other malignancies are eligible if they have remained disease free for at least 2 years prior to trial entry and in the opinion of the investigator deemed to have a low likelihood of recurrence. 16. Any clinically significant medical, psychiatric, or social condition; or laboratory abnormality that may increase the risk of trial participation or may interfere with the informed consent process and/or with compliance with the requirements of the trial or may interfere with the interpretation of the trial results and, in the Investigator's opinion, would make the patient inappropriate for entry into this trial. 17. Pregnant or lactating women. 18. Current swab-positive or suspected (under investigation) COVID19 infection or fever and other signs or symptoms suggestive of COVID-19 infection with recent contact of person(s) with confirmed COVID-19 infection, at screening or Cycle 1 Day 1. 19. Patients with any known contraindication to receive trastuzumab, or capecitabine, or oxaliplatin. 20. Known hypersensitivity to trastuzumab, capecitabine, oxaliplatin, or to any of its components.

Treatments Being Tested

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.

Locations (8)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

HCG Cancer Center

Vizag, Andhra Pradesh, India

Shalby Hospital

Ahmedabad, Gujarat, India

The Gujarat Cancer & Research Insititute

Ahmedabad, Gujarat, India

Kiran Hospital Multi Super Speciality Hospital & Reseach Center

Surat, Gujarat, India

Asha Hospital and Research Centre

Bangalore, Karnataka, India

Karnataka Cancer Hospital and Radiation Theraphy Center

Bangalore, Karnataka, India

Netaji Subhas Chandra Bose Cancer Hospital

Kolkata, West Bengal, India

Hope & Heal Cancer Hospital and Research Center

Siliguri, West Bengal, India

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07040059), the sponsor (Aurigene Discovery Technologies Limited), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07040059 clinical trial studying?

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 oxalip… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07040059?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07040059?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07040059. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07040059. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.