Neuroendocrine (NE) TumorsPhase 2BHARAT-3NCT07640737
AUR103 Calcium in Advanced Neuroendocrine Tumours (BHARAT-3 Study)
A Phase 2 study testing AUR103 Calcium in people with Neuroendocrine (NE) Tumors and Advanced NET of GI Origin, run by Aurigene Discovery Technologies Limited at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Neuroendocrine (NE) Tumors, Advanced NET of GI Origin
- What is being tested?
- AUR103 Calcium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesUnited States
- Study dates
- 30 Jun 2026to 31 Jan 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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).
- SSA (Somatostatin Analogues) alone is not considered a line of therapy for Inclusion criterion 4.
- 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
- Hemoglobin ≥ 9 g/dL (Transfusion is allowed to achieve this Hb)
- Total Bilirubin ≤ 1.5 x ULN (Patients with known Gilbert's syndrome are allowed with a Total Bilirubin ≤ 2.5 x ULN).
- AST (SGOT) ≤ 3 x ULN (≤ 5 x ULN if known liver metastasis).
- ALT (SGPT) ≤ 3 x ULN (≤ 5 x ULN if known liver metastasis).
- 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)]).
- -
Who cannot join
- 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].
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- 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).
- -
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Amanchi Swathi contact
5 sites in 1 country
United States5 sites
Mayo Clinic Hospital - Florida
Jacksonville, Florida, 32224
Jason Starr, 1-904-953-2000, starr.jason@mayo.edu
Hoag Family Cancer Institute
Newport Beach, California, 92657
Michael Demeure Demeure, 1-949-557-0285, Michael.Demeure@hoag.org
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Namrata Vijayvergia, 1-215-728-2500, namrata.vijayvergia@fccc.edu
Mayo Clinic Cancer Center (MCCC)
Phoenix, Arizona, 85054
Mohamad Sonbol, 1-507-284-251, SONBOL.MOHAMAD@MAYO.EDU
Mayo Clinic Cancer Center (MCCC)
Rochester, Minnesota, 55905
Patrick McGarrah, 1-507-266-4997, mcccprepteam@mayo.edu
About this study
Official title: 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.
- Being tested
- AUR103 Calcium
- Keywords
- NET Neuroendocrine Tumours, Neoplasms
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AUR103 CalciumDrug
AUR103 Calcium 200mg or 300mg administered twice daily
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: AUR103 Calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Objective response rate ([ORR] = CR + PR) by RECISTv1.1.
Measured: 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)
Time to respone (TTR) will be assessed during the study
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine (NE) TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aurigene Discovery Technologies Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640737
- Sponsor's protocol ID
- AUR103-202
- Acronym
- BHARAT-3
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Due to ethical concerns
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study Evaluating the Efficacy and Safety Agent AUR103 Calcium in Patients With Advanced, Well or Moderately Differentiated Neuroendocrine Tumours (BHARAT-3)
- ClinicalTrials.gov ID
- NCT07640737
- Acronym / sponsor ID
- BHARAT-3 / AUR103-202
- Keywords
- NET Neuroendocrine Tumours, Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Aurigene Discovery Technologies LimitedIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase 2 single agent study AUR103 calcium administered as 200 mg or 300 mg twice daily. | Experimental | Drug: AUR103 CalciumAUR103 Calcium 200mg or 300mg will be administered twice daily |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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.
- Disease progression with last line of therapy.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AUR103 CalciumAUR103 Calcium 200mg or 300mg administered twice daily | Drug | Phase 2 single agent study AUR103 calcium administered as 200 mg or 300 mg twice daily. |
Primary outcome
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.
Objective response rate ([ORR] = CR + PR) by RECISTv1.1.
11 secondary outcomes
Efficacy: Time to response (TTR)
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.
Efficacy: Duration of Response (DOR)
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.
Efficacy: Stable Disease (SD)
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.
Efficacy: Clinical Benefit Rate (CBR)
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.
Efficacy: Progression Free Survival (PFS)
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.
Overall Survival (OS)
Time frame: 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
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.
Pharmacokinetic (PK): Maximum Concentration
Time frame: 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
Time frame: 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 frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No. Due to ethical concerns
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amanchi Swathi contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AUR103 Calcium in people with Neuroendocrine (NE) Tumors and Advanced NET of GI Origin, run by Aurigene Discovery Technologies Limited at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Akhil Kumar, DM (+91 9632203510, akhil_k@aurigene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.