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

NCT07640737 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: AUR103-202
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Neuroendocrine (NE) Tumors; Advanced NET of GI Origin

Keywords

NET Neuroendocrine Tumours; Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Efficacy: Time to response (TTR)

  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)

  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)

  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)

  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)

  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.

Study Arms (1)

Phase 2 single agent study AUR103 calcium administered as 200 mg or 300 mg twice daily.

EXPERIMENTAL

AUR103 Calcium 200mg or 300mg will be administered twice daily

Drug: AUR103 Calcium

Interventions

AUR103 Calcium DRUG

AUR103 Calcium 200mg or 300mg administered twice daily

Phase 2 single agent study AUR103 calcium administered as 200 mg or 300 mg twice daily.

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years.
• Eastern Coorperative Oncology Group (ECOG) Performance status of 0 or 1.
• Pathologically confirmed, well or moderately differentiated (G1 or G2), advanced (unresectable or metastatic), neuroendocrine tumour.
• Patients should have progressed after at least one line of therapy.
• Notes:
• All previous treatments are allowed
• There is no upper limit on the number of prior lines of therapy.
• 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).
• Disease progression with last line of therapy.
• Measurable disease by RECISTv1.1.
• If the patient is receiving Somatostatin analouges (SSA), the patient should be on stable doses for at least 2 months.
• \[Note: Concomitant Somatostatin analouges (SSA) are allowed. No other therapies for NET are allowed along with study drug (e,g., everolimus, sunitinib, cabozantinib, peptide receptor radionuclide therapy (PRRT), chemotherapy etc.)\].
• Acceptable bone marrow and organ function at screening as described below:
• ANC ≥1000/ μL
• Platelet count ≥ 80,000/μL

You may not qualify if:

• Neuroendocrine carcinoma, such as small cell carcinoma.
• Grade 3 neuroendocrine tumours (NET) and/or Poorly differentiated NET.
• Patients with known MEN-1 (Multiple Endocrine Neoplasia-1) or MEN-2 (Multiple Endocrine Neoplasia-2) syndromes.
• Known impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral AUR103 calcium.
• 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.
• \[Note: Concomitant use of SSA is allowed\].
• Patients who have used PRRT as a previous line would require 6 weeks from the last dose, before Cycle 1 Day 1.
• 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.
• Use of any investigational agent within 21 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
• 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.
• Major surgery ≤ 28 days from Cycle 1 Day 1 (major surgery is defined as a procedure requiring general anesthesia).
• Hepatic intra-arterial embolization within the last 6 months. Cryoablation or radiofrequency ablation of hepatic metastases within 2 months of randomization.
• 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.
• \[Note: Patients with other malignancies are eligible if they have remained disease free for at least 2 years prior to trial entry and in the opinion of the investigator deemed to have a low likelihood of recurrence\].
• Active infection requring systemic therapy. \[Note: Prophylactic use of antibiotics is allowed. Any infection detected during screening period which is resolved adequately according to investigator before the Cycle 1 Day 1, is allowed\].

Sponsors & Collaborators

• Aurigene Discovery Technologies Limited: lead

Study Sites (5)

Mayo Clinic Cancer Center (MCCC)

Phoenix, Arizona, 85054, United States

Location

Hoag Family Cancer Institute

Newport Beach, California, 92657, United States

Location

Mayo Clinic Hospital - Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic Cancer Center (MCCC)

Rochester, Minnesota, 55905, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Akhil Kumar, DM

CONTACT

+91 9632203510; akhil_k@aurigene.com

Amanchi Swathi

CONTACT

+91 9010789532

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 11, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): January 31, 2029
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)