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 | Terminated Phase 1 FDA Drug

• 1 other identifier: AUR103-201
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 8

Brief 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

Gastroesophageal Junction Adenocarcinoma; HER 2 Positive Gastric Cancer

Keywords

BHARAT 2

Outcome Measures

Primary Outcomes (6)

• 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)

  Through the study completion, an average of 1 year

• Part 1 (Pharmacokinetics): Area under the curve (AUC)

  Area under the curve of AUR103 Calcium

  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.

• Part 1 (Pharmacokinetics): Maximum concentration

  Maximum concentration of AUR103 Calcium

  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.

• Part 1 (Pharmacokinetics): Time to Maximum concentration

  Time to Maximum concentration of AUR103 Calcium

  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.

• Part 1 (Pharmacokinetics): Terminal elimination half life

  Terminal elimination half-life of AUR103 Calcium

  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.

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

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

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

Secondary Outcomes (18)

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

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

• Part 1 (Efficacy): Duration of response (DoR)

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

• Part 1 (Efficacy): Time to Objective Tumor Response

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

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

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

• Part 1 (Efficacy): Clinical Benefit Rate (CBR)

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

Study Arms (5)

Phase 1b (Cohort 1: AUR103 Calcium 200 mg BID with standard dose of Trastuzumab and CAPOX.

EXPERIMENTAL

Phase 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.

Drug: AUR103 Calcium

Phase 2 Treatment Arm

EXPERIMENTAL

Phase 2 (Experimental Arm) - Either one or two treatment arm(s) selected from the Phase 1b part.

Drug: AUR103 Calcium

Phase 2 Control Arm

ACTIVE COMPARATOR

Phase 2 will have control arm (with standard dose of Trastuzumab and CAPOX).

Drug: Trastuzumab + CAPOX (Capecitabine + Oxaliplatin)

Phase 1b (Cohort 2: AUR103 Calcium 300 mg BID with standard dose of Trastuzumab and CAPOX.

EXPERIMENTAL

Drug: AUR103 Calcium

Phase 1b: Cohort 3 (AUR103 Calcium 400 mg BID with standard dose of Trastuzumab and CAPOX).

EXPERIMENTAL

Phase 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.

Drug: AUR103 Calcium

Interventions

AUR103 Calcium DRUG

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

Also known as: Trastuzumab, Capecitabine

Phase 1b (Cohort 1: AUR103 Calcium 200 mg BID with standard dose of Trastuzumab and CAPOX.; Phase 1b (Cohort 2: AUR103 Calcium 300 mg BID with standard dose of Trastuzumab and CAPOX.; Phase 1b: Cohort 3 (AUR103 Calcium 400 mg BID with standard dose of Trastuzumab and CAPOX).; Phase 2 Treatment Arm

Trastuzumab + CAPOX (Capecitabine + Oxaliplatin) DRUG

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

Also known as: Trastuzumab, Capecitabine

Phase 2 Control Arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.
• \[Note: The partial resection of tumor or debulking surgery is allowed but any therapeutic chemotherapy or systemic anti-cancer therapy is not allowed\].
• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Aurigene Discovery Technologies Limited: lead

Study Sites (8)

HCG Cancer Center

Vizag, Andhra Pradesh, 530040, India

Location

Shalby Hospital

Ahmedabad, Gujarat, 380015, India

Location

The Gujarat Cancer & Research Insititute

Ahmedabad, Gujarat, 380016, India

Location

Kiran Hospital Multi Super Speciality Hospital & Reseach Center

Surat, Gujarat, 395004, India

Location

Asha Hospital and Research Centre

Bangalore, Karnataka, 560076, India

Location

Karnataka Cancer Hospital and Radiation Theraphy Center

Bangalore, Karnataka, 560096, India

Location

Netaji Subhas Chandra Bose Cancer Hospital

Kolkata, West Bengal, 700094, India

Location

Hope & Heal Cancer Hospital and Research Center

Siliguri, West Bengal, 734015, India

Location

MeSH Terms

Interventions

Trastuzumab; Capecitabine; Oxaliplatin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Akhil Kumar

  Aurigene Oncology Limited

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 26, 2025
• Study Start: March 22, 2025
• Primary Completion: December 29, 2025
• Study Completion: December 29, 2025
• Last Updated: April 17, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (8)