AUR103 Calcium in Advanced Neuroendocrine Tumours (BHARAT-3 Study) (BHARAT-3)

A Phase 2 Study Evaluating the Efficacy and Safety Agent AUR103 Calcium in Patients With Advanced, Well or Moderately Differentiated Neuroendocrine Tumours (BHARAT-3)

A phase 2 Study Evaluating the Efficacy and Safety of Single Agent AUR103 Calcium in Patients with Advanced, Well or Moderately differentiated Neuroendocrine Tumours.

This is a Proof of Concept (PoC) Phase 2 study of AUR103 calcium in patients with advanced, well or moderately differentiated neuroendocrine tumours.

The main objective is to evaluate the efficacy of AUR103 calcium in patients with well or moderately differentiated neuroendocrine tumors.

Patients with relapsed/refractory well or moderately differentiated neuroendocrine tumors.

AUR103 calcium will be administered twice daily. Patients will receive AUR103 calcium until disease progression or intolerable toxicity.

Study Overview

• Status: Not yet recruiting
• Conditions: Neuroendocrine (NE) Tumors; Advanced NET of GI Origin
• Intervention / Treatment: Drug: AUR103 Calcium

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Akhil Kumar, DM; Phone Number: +91 9632203510; Email: akhil_k@aurigene.com
• Study Contact Backup: Name: Amanchi Swathi; Phone Number: +91 9010789532

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Cancer Center (MCCC)
      • Contact: Mohamad Sonbol; Phone Number: 1-507-284-251; Email: SONBOL.MOHAMAD@MAYO.EDU
  • California
    • Newport Beach, California, United States, 92657
      • Hoag Family Cancer Institute
      • Contact: Michael Demeure Demeure; Phone Number: 1-949-557-0285; Email: Michael.Demeure@hoag.org
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Hospital - Florida
      • Contact: Jason Starr; Phone Number: 1-904-953-2000; Email: starr.jason@mayo.edu
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Cancer Center (MCCC)
      • Contact: Patrick McGarrah; Phone Number: 1-507-266-4997; Email: mcccprepteam@mayo.edu
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
      • Contact: Namrata Vijayvergia; Phone Number: 1-215-728-2500; Email: namrata.vijayvergia@fccc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years.
2. Eastern Coorperative Oncology Group (ECOG) Performance status of 0 or 1.
3. Pathologically confirmed, well or moderately differentiated (G1 or G2), advanced (unresectable or metastatic), neuroendocrine tumour.

4. Patients should have progressed after at least one line of therapy.

   Notes:

   1. All previous treatments are allowed
   2. There is no upper limit on the number of prior lines of therapy.
   3. Patient should have received at least one FDA approved therapy for his/her disease (i.e., Patient should have received at least one of everolimus, sunitinib, cabozantinib or Lu177 dotatate for his/her specific NET, as per FDA approved package insert).
   4. SSA (Somatostatin Analogues) alone is not considered a line of therapy for Inclusion criterion 4.
5. Disease progression with last line of therapy.
6. Measurable disease by RECISTv1.1.

7. If the patient is receiving Somatostatin analouges (SSA), the patient should be on stable doses for at least 2 months.

   [Note: Concomitant Somatostatin analouges (SSA) are allowed. No other therapies for NET are allowed along with study drug (e,g., everolimus, sunitinib, cabozantinib, peptide receptor radionuclide therapy (PRRT), chemotherapy etc.)].

8. Acceptable bone marrow and organ function at screening as described below:

   1. ANC ≥1000/ μL
   2. Platelet count ≥ 80,000/μL
   3. Hemoglobin ≥ 9 g/dL (Transfusion is allowed to achieve this Hb)
9. Total Bilirubin ≤ 1.5 x ULN (Patients with known Gilbert's syndrome are allowed with a Total Bilirubin ≤ 2.5 x ULN).
10. AST (SGOT) ≤ 3 x ULN (≤ 5 x ULN if known liver metastasis).
11. ALT (SGPT) ≤ 3 x ULN (≤ 5 x ULN if known liver metastasis).
12. Creatinine clearance (CrCl) ≥ 60 mL/min (either measured or estimated by the Cockcroft-Gault formula).

(Note: Cockcroft-Gault formula for estimated creatinine clearance [eCrCl]: eCrCl = [140- Age] × Weight [kg] × [0.85 if Female] / [72 × serum creatinine (mg/dL)]).

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Exclusion Criteria:

1. Neuroendocrine carcinoma, such as small cell carcinoma.
2. Grade 3 neuroendocrine tumours (NET) and/or Poorly differentiated NET.
3. Patients with known MEN-1 (Multiple Endocrine Neoplasia-1) or MEN-2 (Multiple Endocrine Neoplasia-2) syndromes.
4. Known impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral AUR103 calcium.

5. Systemic anti-cancer therapy, such as small molecule TKIs, mTOR inhibitors, chemotherapy, biological therapy, or immunomodulatory drug therapy, received within the past 28 days or 5 half-lives, whichever is longer, from the Cycle 1 Day 1 of the study.

   [Note: Concomitant use of SSA is allowed].

6. Patients who have used PRRT as a previous line would require 6 weeks from the last dose, before Cycle 1 Day 1.
7. Presence of an acute or chronic toxicity resulting from prior anticancer treatment, except for alopecia or nail changes, that has not resolved to Grade ≤ 1, as determined by NCI CTCAE v 5.0.
8. Use of any investigational agent within 21 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
9. Known symptomatic or untreated or recently treated (≤ 6 months of screening) CNS metastases. Patients with previously treated (> 6 months of screening) brain metastasis and are now stable and asymptomatic, from CNS perspective, are allowed.
10. Major surgery ≤ 28 days from Cycle 1 Day 1 (major surgery is defined as a procedure requiring general anesthesia).
11. Hepatic intra-arterial embolization within the last 6 months. Cryoablation or radiofrequency ablation of hepatic metastases within 2 months of randomization.

12. Presence of any additional malignancy within last 3 years, except basal-cell or squamous cell carcinoma of the skin or carcinoma-in situ of the uterine cervix.

    [Note: 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].

13. Active infection requring systemic therapy. [Note: Prophylactic use of antibiotics is allowed. Any infection detected during screening period which is resolved adequately according to investigator before the Cycle 1 Day 1, is allowed].
14. Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome-related illness.
15. Known active or chronic hepatitis B (HBsAg +ve), hepatitis C infection (HCV antibody +ve).
16. Expected to require any other form of antineoplastic therapy or targeted therapy while on study.
17. 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.
18. Ongoing cardiac dysrhythmias requiring treatment of any grade or treatment of cardiac dysrhythmias in past 3 months, before Cycle 1 Day 1.
19. Mean QTcF (Fridericia) interval >460 ms on ECG at screening or at Cycle 1 Day 1 pre-dose.
20. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or significant gastritis, active bleeding diatheses, presence of any major medical illness (e.g., renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, or psychiatric illness/social situations or clinically significant laboratory / ECG abnormalities at screening, any or a combination of illnesses), which, in the opinion of the principal investigator (PI), may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study.
21. Current swab-positive or suspected (under investigation) COVID-19 infection or fever and other signs or symptoms suggestive of COVID19 infection with recent contact of person(s) with confirmed COVID19 infection, at screening or Day 1 of Cycle 1.
22. Positive pregnancy test for women of child-bearing potential (WOCBP) at the screening or enrolment visit, or lactating women.

23. Women of child-bearing potential (WOCBP) who are neither surgically sterilized nor willing to use reliable contraceptive methods (hormonal contraceptive, IUD, or any double combination of male or female condom, spermicidal gel, diaphragm, sponge, cervical cap).

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 2 single agent study AUR103 calcium administered as 200 mg or 300 mg twice daily.; AUR103 Calcium 200mg or 300mg will be administered twice daily	Drug: AUR103 Calcium; AUR103 Calcium 200mg or 300mg administered twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate	Objective response rate ([ORR] = CR + PR) by RECISTv1.1.	3rd week (Days 15-21) of Cycle 2, and thereafter every 2 cycles up till Cycle 6 (i.e., between Day 15-21 of Cycles 4, 6) and then every 3 cycles (i.e., towards the end of Cycle 9, 12). Each treatment cycle will be 28 days in length.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy: Time to response (TTR)	Time to respone (TTR) will be assessed during the study	3rd week (Days 15-21) of Cycle 2, and thereafter every 2 cycles up till Cycle 6 (i.e., between Day 15-21 of Cycles 4, 6) and then every 3 cycles (i.e., towards the end of Cycle 9, 12). Each treatment cycle will be 28 days in length.
Efficacy: Duration of Response (DOR)	Duration of Response (DOR) will be assessed during the study	3rd week (Days 15-21) of Cycle 2, and thereafter every 2 cycles up till Cycle 6 (i.e., between Day 15-21 of Cycles 4, 6) and then every 3 cycles (i.e., towards the end of Cycle 9, 12). Each treatment cycle will be 28 days in length.
Efficacy: Stable Disease (SD)	Sable Disease (SD) will be assessed during the study	3rd week (Days 15-21) of Cycle 2, and thereafter every 2 cycles up till Cycle 6 (i.e., between Day 15-21 of Cycles 4, 6) and then every 3 cycles (i.e., towards the end of Cycle 9, 12). Each treatment cycle will be 28 days in length.
Efficacy: Clinical Benefit Rate (CBR)	Duration of Clinical Benefit Rate (CBR) will be assessed during the study	3rd week (Days 15-21) of Cycle 2, and thereafter every 2 cycles up till Cycle 6 (i.e., between Day 15-21 of Cycles 4, 6) and then every 3 cycles (i.e., towards the end of Cycle 9, 12). Each treatment cycle will be 28 days in length.
Efficacy: Progression Free Survival (PFS)	Progress Free Survival (PFS) will be assessed during the study	3rd week (Days 15-21) of Cycle 2, and thereafter every 2 cycles up till Cycle 6 (i.e., between Day 15-21 of Cycles 4, 6) and then every 3 cycles (i.e., towards the end of Cycle 9, 12). Each treatment cycle will be 28 days in length.
Overall Survival (OS)	Overall Survival (OS) will be assessed during the study	Through study completion, an average of 1 year at the end of cycle 12 or as clinically indicated. Each treatment cycle will be 28 days in length.
Safety and Tolerability of AUR103 calcium	Safety and tolerability of AUR103 calcium is measured in the study as per the NCI CTCAE 5.0 criteria	3rd week (Days 15-21) of Cycle 2, and thereafter every 2 cycles up till Cycle 6 (i.e., between Day 15-21 of Cycles 4, 6) and then every 3 cycles (i.e., towards the end of Cycle 9, 12). Each treatment cycle will be 28 days in length.
Pharmacokinetic (PK): Maximum Concentration	Maximum concentration of AUR103 Calcium	Cycle 1 Day 1 and Cycle 1 Day 15. Blood collection at 9 different time points [pre-dose , 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after morning dose] on Day 1 and Day 15 and 12 hours after the evening dose on Day 1 & Day 15.
Pharmacokinetic (PK): Minimum Concentration	Minimum concentration of AUR103 calcium	Cycle 1 Day 1 and Cycle 1 Day 15. Blood collection at 9 different time points [pre-dose , 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after morning dose] on Day 1 and Day 15 and 12 hours after the evening dose on Day 1 & Day 15.
Pharmacokinetics (PK): Time to Maximum Concentration	Time to Maximum concentration of AUR103 Calcium	Cycle 1 Day 1 and Cycle 1 Day 15. Blood collection at 9 different time points [pre-dose , 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after morning dose] on Day 1 and Day 15 and 12 hours after the evening dose on Day 1 & Day 15.
Pharmacokinetics (PK): Terminal elimination half life	Terminal elimination half-life of AUR103 Calcium	Cycle 1 Day 1 and Cycle 1 Day 15. Blood collection at 9 different time points [pre-dose , 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after morning dose] on Day 1 and Day 15 and 12 hours after the evening dose on Day 1 & Day 15.

Collaborators and Investigators

• Sponsor: Aurigene Discovery Technologies Limited

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): January 31, 2029

Study Registration Dates

• First Submitted: June 3, 2026
• First Submitted That Met QC Criteria: June 10, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Neoplasms; NET Neuroendocrine Tumours
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: AUR103-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to ethical concerns

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No