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

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].

Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome-related illness.

Known active or chronic hepatitis B (HBsAg +ve), hepatitis C infection (HCV antibody +ve).

Expected to require any other form of antineoplastic therapy or targeted therapy while on study.

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.

Mean QTcF (Fridericia) interval >460 ms on ECG at screening or at Cycle 1 Day 1 pre-dose.

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.

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.

Positive pregnancy test for women of child-bearing potential (WOCBP) at the screening or enrolment visit, or lactating women.

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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