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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Aurigene Discovery Technologies Limited
Study ID
NCT07640737
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced NET of GI Origin
  • Neuroendocrine (NE) Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • AUR103 Calcium — DRUG
    AUR103 Calcium 200mg or 300mg administered twice daily

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Dec 30, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Objective response rate [ Time Frame: 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. ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Mayo Clinic Cancer Center (MCCC)PhoenixArizona85054
Mohamad Sonbol
[email protected]
1-507-284-251
Hoag Family Cancer InstituteNewport BeachCalifornia92657
Michael Demeure Demeure
[email protected]
1-949-557-0285
Mayo Clinic Hospital - FloridaJacksonvilleFlorida32224
Jason Starr
[email protected]
1-904-953-2000
Mayo Clinic Cancer Center (MCCC)RochesterMinnesota55905
Patrick McGarrah
[email protected]
1-507-266-4997
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111
Namrata Vijayvergia
[email protected]
1-215-728-2500

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic Cancer Center (MCCC)· Phoenix, AZHoag Family Cancer Institute· Newport Beach, CAMayo Clinic Hospital - Florida· Jacksonville, FLMayo Clinic Cancer Center (MCCC)· Rochester, MNFox Chase Cancer Center· Philadelphia, PA

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