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HER 2 Positive Gastric CancerPhase 1/2NCT07040059

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 1/2 study testing AUR103 Calcium and Trastuzumab + CAPOX (Capecitabine + Oxaliplatin) in people with HER 2 Positive Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by Aurigene Discovery Technologies Limited at 8 sites in India.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
AUR103 Calcium and Trastuzumab + CAPOX (Capecitabine + Oxaliplatin)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
8 sitesIndia
Study dates
22 Mar 2025to 29 Dec 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provide signed and dated informed consent and agree to comply with all study related activities.
  • Male or female patients aged greater than or equal to 18 years.
  • Patients must meet the following criteria for each of the respective parts of the study:
  • 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].
  • Patients must NOT have received any systemic anti-cancer therapy for the treatment of gastric or gastroesophageal (GE) junction adenocarcinoma.
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  • [Note: The partial resection of tumor or debulking surgery is allowed but any therapeutic chemotherapy or systemic anti-cancer therapy is not allowed].
  • Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
  • Acceptable bone marrow as described below:
  • ANC greater than or equal to 1500/μL (without WBC growth factor support).
  • Platelet count greater than or equal to 100,000/μL (without transfusion support).
  • Hemoglobin greater than or equal to 9 g/dL (Transfusion is allowed to achieve this Hb).
  • Acceptable organ function as described below:
  • 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).
  • AST (SGOT) less than or equal to 3 x ULN (less than or equal to 5 × ULN if known liver metastases).
  • ALT (SGPT) less than or equal to 3 x ULN (less than or equal to 5 × ULN if known liver metastases).
  • 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)]).
  • Albumin greater than or equal to 3.0 g/dL.
  • 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].
  • 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].
  • Left ventricular ejection fraction (LVEF) greater than or equal to 50% by either echocardiogram (ECHO) or multigated acquisition (MUGA) scan at Screening.
  • Ability to swallow and retain oral medications.
  • Negative serum pregnancy test in women of childbearing potential (WOCBP).
  • 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).

Who cannot join

  • Patients with resectable gastric / gastroesophageal (GE) junction adenocarcinoma.
  • Exposed to definitive radiotherapy [Note: Palliative radiotherapy is allowed].
  • Use of any investigational agent within 28 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
  • Known central nervous system (CNS) metastases.
  • Major surgery less than or equal to 28 days from Cycle 1 Day 1 (Major surgery is defined as a procedure requiring general anaesthesia).
  • Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome-related illness.
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  • Known active or chronic hepatitis B or hepatitis C infection.
  • 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.
  • Ongoing cardiac dysrhythmias requiring treatment of any grade or treatment of cardiac dysrhythmias in past 3 months, before Cycle 1 Day 1.
  • The QTcF (corrected QT interval Fridericia method) value in the screening ECG more than 460 ms in males and females.
  • Currently taking warfarin or other oral coumarin-derivative anticoagulant therapy.
  • Patients with peripheral neuropathy of Grade greater than or equal to 2.
  • Patients with severe obstructive pulmonary disease, pulmonary fibrosis, or interstitial lung disease.
  • 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.
  • 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.
  • 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.
  • Pregnant or lactating women.
  • 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.
  • Patients with any known contraindication to receive trastuzumab, or capecitabine, or oxaliplatin.
  • Known hypersensitivity to trastuzumab, capecitabine, oxaliplatin, or to any of its components.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

India8 sites

  • Shalby Hospital

    Ahmedabad, Gujarat, 380015

  • The Gujarat Cancer & Research Insititute

    Ahmedabad, Gujarat, 380016

  • Asha Hospital and Research Centre

    Bangalore, Karnataka, 560076

  • Karnataka Cancer Hospital and Radiation Theraphy Center

    Bangalore, Karnataka, 560096

  • Netaji Subhas Chandra Bose Cancer Hospital

    Kolkata, West Bengal, 700094

  • Hope & Heal Cancer Hospital and Research Center

    Siliguri, West Bengal, 734015

  • Kiran Hospital Multi Super Speciality Hospital & Reseach Center

    Surat, Gujarat, 395004

  • HCG Cancer Center

    Vizag, Andhra Pradesh, 530040

Other trials in India

About this study

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)

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.

Read the 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.

Being tested
AUR103 Calcium, Trastuzumab + CAPOX (Capecitabine + Oxaliplatin)
Keywords
BHARAT 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AUR103 CalciumDrug

    Also called Trastuzumab, Capecitabine

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

  • Trastuzumab + CAPOX (Capecitabine + Oxaliplatin)Drug

    Also called Trastuzumab, Capecitabine

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

Study groups in NCT07040059
Study groupRoleWhat they receive
Phase 1b (Cohort 1: AUR103 Calcium 200 mg BID with standard dose of Trastuzumab and CAPOX.ExperimentalPhase 1b: Cohort 2 (AUR103 Calcium 300 mg BID with standard dose of Trastuzumab and CAPOX). Cohort 2 of Phase 1b will start after completion of dose-limiting toxicity (DLT) period of Cohort 1.
Receives: Drug: AUR103 Calcium
Phase 2 Treatment ArmExperimentalPhase 2 (Experimental Arm) - Either one or two treatment arm(s) selected from the Phase 1b part.
Receives: Drug: AUR103 Calcium
Phase 2 Control ArmActive comparatorPhase 2 will have control arm (with standard dose of Trastuzumab and CAPOX).
Receives: Drug: Trastuzumab + CAPOX (Capecitabine + Oxaliplatin)
Phase 1b (Cohort 2: AUR103 Calcium 300 mg BID with standard dose of Trastuzumab and CAPOX.ExperimentalNot described
Receives: Drug: AUR103 Calcium
Phase 1b: Cohort 3 (AUR103 Calcium 400 mg BID with standard dose of Trastuzumab and CAPOX).ExperimentalPhase 1b: Cohort 3 (AUR103 Calcium 400 mg BID with standard dose of Trastuzumab and CAPOX). Cohort 3 of Phase 1b will start after completion of dose-limiting toxicity (DLT) period of Cohort 2.
Receives: Drug: AUR103 Calcium

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1 (Safety): Treatment Emergent Adverse Events (TEAEs)

    TEAEs will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)

    Measured: Through the study completion, an average of 1 year

  2. Part 1 (Pharmacokinetics): Area under the curve (AUC)

    Area under the curve of AUR103 Calcium

    Measured: On Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent cycle through study completion, for an average duration of one year.

  3. Part 1 (Pharmacokinetics): Maximum concentration

    Maximum concentration of AUR103 Calcium

    Measured: On Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent cycle through study completion, for an average duration of one year.

  4. Part 1 (Pharmacokinetics): Time to Maximum concentration

    Time to Maximum concentration of AUR103 Calcium

    Measured: On Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent cycle through study completion, for an average duration of one year.

  5. Part 1 (Pharmacokinetics): Terminal elimination half life

    Terminal elimination half-life of AUR103 Calcium

    Measured: On Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent cycle through study completion, for an average duration of one year.

  6. Part 2 (Efficacy): Best Objective Tumor Response Rate (ORR)

    Best Objective Tumor Response Rate (ORR) will be assessed during the study

    Measured: Every 3 cycle, through study completion, for an average duration of one year.

Secondary outcomes (18)

  1. Part 1 (Efficacy): Best Objective Tumor Response Rate (ORR)

    ORR will be assessed during the study during the study

    Measured: Every 3 cycle, through study completion, for an average duration of one year.

  2. Part 1 (Efficacy): Duration of response (DoR)

    Duration of response (DoR) will be assessed during the study

    Measured: Every 3 cycle, through study completion, for an average duration of one year.

  3. Part 1 (Efficacy): Time to Objective Tumor Response

    Time to Objective Tumor Response will be assessed during the study

    Measured: Every 3 cycle, through study completion, for an average duration of one year.

  4. Part 1 (Efficacy): Duration of Clinical Benefit Rate (CBR)

    Duration of Clinical Benefit Rate (CBR) will be assessed during the study

    Measured: Every 3 cycle, through study completion, for an average duration of one year.

  5. Part 1 (Efficacy): Clinical Benefit Rate (CBR)

    Clinical Benefit Rate (CBR) will be assessed during the study

    Measured: Every 3 cycle, through study completion, for an average duration of one year.

  6. Part 1 (Efficacy): Progression Free Survival (PFS)

    Progression Free Survival (PFS) will be assessed during the study

    Measured: Every 3 cycle, through study completion, for an average duration of one year.

  7. Part 1 (Efficacy): Time to progression

    Time to progression will be assessed during the study

    Measured: Every 3 cycle, through study completion, for an average duration of one year.

  8. Part 1 (Efficacy): Overall survival (OS)

    Overall survival will be assessed during the study

    Measured: Through study completion, an average of 1 year

  9. Part 2 (Efficacy): Duration of response

    Duration of response will be assessed during the study

    Measured: Every 3 cycle, through study completion, for an average duration of one year.

  10. Part 2 (Efficacy): Time to Objective Tumor Response

    Time to Objective Tumor Response will be assessed during the study

    Measured: Every 3 cycle, through study completion, for an average duration of one year.

  11. Part 2 (Efficacy): Clinical Benefit Rate (CBR)

    Clinical Benefit Rate (CBR) will be assessed during the study

    Measured: Every 3 cycle, through study completion, for an average duration of one year.

  12. Part 2 (Efficacy): Duration of Clinical Benefit Rate (CBR)

    Duration of Clinical Benefit Rate (CBR) will be assessed during the study

    Measured: Every 3 cycle, through study completion, for an average duration of one year.

  13. Part 2 (Efficacy): Progression Free Survival (PFS)

    Progression Free Survival (PFS) will be assessed during the study

    Measured: Every 3 cycle, through study completion, for an average duration of one year.

  14. Part 2 (Efficacy): Time to progression

    Time to progression will be assessed during the study

    Measured: Every 3 cycle, through study completion, for an average duration of one year.

  15. Part 2 (Efficacy): Overall survival (OS)

    Overall survival will be assessed during the study

    Measured: Through study completion, an average of 1 year

  16. Part 2 (Safety): Treatment Emergent Adverse Events (TEAEs)

    Treatment Emergent Adverse Events (TEAEs) will be assessed throughout the study duration

    Measured: Through study completion, an average of 1 year

  17. Part 2 (Health Related Quality of Life): EORTC QLQ-C30

    Health Related Quality of Life will be assessed by EORTC QLQ-C30 questionaire

    Measured: Cycle 1 Day 1 and Day 1 of each subsequent cycle through study completion, for an average duration of one year.

  18. Part 2 (Health Related Quality of Life): EORTC-QLQ-STO22 score

    Health Related Quality of Life will be assessed by EORTC-QLQ-STO22 score

    Measured: Cycle 1 Day 1 and Day 1 of each subsequent cycle through study completion, for an average duration of one year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2025
  2. Study start22 Mar 2025
  3. Primary completion29 Dec 2025
  4. Study completion29 Dec 2025

Why it stopped: Patient recruitment problems.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
The Phase 1 of the study is a single-arm study, which will be conducted in a dose-escalation manner by following 3 + 3 traditional design. The Phase 2 of the study is a randomized study with either two or three groups with parallel study design. The number of groups in the Phase 2 part of the study will be decided based on the safety, PK and/or PD data from Phase 1.
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07040059
Sponsor's protocol ID
AUR103-201
Status last verified
Jun 2025
First submitted
4 Jun 2025
Last updated
17 Apr 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Due to ethical concerns.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AUR103 Calcium and Trastuzumab + CAPOX (Capecitabine + Oxaliplatin) in people with HER 2 Positive Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by Aurigene Discovery Technologies Limited at 8 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Patient recruitment problems.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1 (Safety): Treatment Emergent Adverse Events (TEAEs) (time frame: Through the study completion, an average of 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07040059.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.

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