AUR103 Calcium in Advanced Neuroendocrine Tumours (BHARAT-3 Study)
United States30 participantsStarted 2026-06-30
Plain-language 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.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective response rate
Timeframe: 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.
. 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.
. 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.