Relapsed Advanced LymphomasPhase 1ASHA-1NCT05984147
A Study Evaluating the Safety and Efficacy of AUR108 in Patients With Relapsed Advanced Lymphomas (ASHA-1)
A Phase 1 study testing AUR108 in people with Relapsed Advanced Lymphomas, run by Aurigene Discovery Technologies Limited at 27 sites in India.
Trial summary
An open-label, first-in-human, Phase 1 study in adult patients with relapsed advanced lymphomas will be done to assess AUR108 safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Relapsed Advanced Lymphomas
- What is being tested?
- AUR108
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 27 sitesIndia
- Study dates
- 19 Oct 2023to 30 Aug 2027
- Phase
- Phase 1
- 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
- Males or females ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1
- Acceptable bone marrow and organ function at screening as described below:
- ANC ≥ 1000/μL (without WBC growth factor support)
- Platelet count ≥ 75,000/μL without transfusion support
- Hemoglobin ≥ 9 g/dL (Transfusion is allowed to achieve this Hb)
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- 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 × ULN if known liver metastases)
- ALT (SGPT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases)
- Creatinine clearance (CrCl) ≥ 30 mL/min (either measured or estimated by the Cockcroft-Gault formula). (Cockcroft-Gault formula for estimated creatinine clearance [eCrCl]: eCrCl = [140- Age] × Weight [kg] × [0.85 if Female] / [72 × serum creatinine (mg/dL)]).
- Ability to swallow and retain oral medications
- Histo-pathological diagnosis of a Non-Hodgkin lymphoma orHodgkin Lymphoma. Note: The lymphoma should be either in Stage III or IV according to Lugano classification (Cheson BD et al, 2014) at screening.
- In the case of subjects who have lymphoma for which high-dose chemotherapy and autologous stem cell transplantation (HDASCT) is considered a standard curative therapy, eligibility for this study requires that the subject's disease has relapsed after HDASCT, that the subject is not eligible for HD-ASCT, or that the subject has refused HD-ASCT.
- In the case of subjects who have lymphoma for which CAR-T therapy is considered a standard therapy, eligibility for this study requires that the subjects disease has relapsed after CAR-T, or that the subject has refused CAR-T, or that the CAR-T therapy is not accessible to the patient.
- Evidence of measurable disease as per Lugano Criteria for Lymphoma (Cheson BD et al, 2014).
- Standard curative measures do not exist, and patient must have exhausted all effective therapies, available locally.
- At a minimum, the patients must have received at least 2 prior lines of systemic therapies. These systemic therapies could be either in the stage II, III or IV.
- Any cancer patient with access to any effective therapy must not be enrolled.
Who cannot join
- Systemic anti-cancer therapy, such as chemotherapy, or biological therapy, 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 low dose prednisone (up to 10 mg/day) is allowed.
- Presence of an acute or chronic toxicity resulting from prior anticancer treatment, with the exception of alopecia or nail changes, that has not resolved to Grade ≤ 1, as determined by NCI CTCAE v 5.0.
- Definitive Radiotherapy within the last 21 days of Cycle 1 Day 1 (limited field palliative radiation is allowed and no restrictions during the screening period or during the trial).
- Use of any investigational agent within 28 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
- Patients with cutaneous lymphomas, mycosis fungoides (MF) or Sézary syndrome (SS).
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- Primary CNS lymphoma
- Known symptomatic or untreated or recently treated (≤ 6 months of screening) central nervous system (CNS) lymphoma. Patients with previously treated (> 6 months of screening) CNS lymphoma and are now stable and asymptomatic, from CNS perspective, are allowed
- Patients with lymphoma that requires immediate cytoreductive therapy
- Patients with lymphoma that requires immediate cytoreductive therapy
- Patients on the drugs which are sensitive substrates of CYP2C8 and cannot be discontinued at least one week prior to Cycle 1 Day 1
- Patients on the drugs which are sensitive substrates of either Poglycoprotein (P-gp) or breast cancer resistance protein (BCRP) and cannot be discontinued at least one week prior to Cycle 1 Day 1
- Major surgery ≤ 28 days from Cycle 1 Day 1 (major surgery is defined as a procedure requiring general anesthesia)
- Active infection requiring 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) or hepatitis C infection (HCV antibody +ve)
- The patient who is 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.
- QTc (Bazzett) interval >460 ms on ECG at screening and/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 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 Covid-19 infection with recent contact of person(s) with confirmed Covid-19 infection, at screening or Cycle 1 Day 1.
- History of another primary malignancy within 5 years prior to starting study drug, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study.
- Positive pregnancy test for women of child-bearing potential (WOCBP) at the screening or enrolment visit
- Lactating women or 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
27 sites in 1 country. Contact the study team or a site near you to ask about taking part.
27 sites in 1 country
India27 sites, 27 recruiting
- Recruiting
Cellcure Care Cancer Pvt Ltd
Ahmedabad, Gujarat, 380009
Dr Sandip Shah, MBBS,MD, 9824041170, sandip60@yahoo.com
Dr Sandip Shah, MBBS,MD
- Recruiting
HCC Happiness Care and Cure Multispeciality Hospital
Ahmedabad, Gujarat, 380015
Akash Patel, MBBS, 8826001414, drakash.cr@gmail.com
- Recruiting
Shankus Hospital Pvt. Ltd.
Ahmedabad, Gujarat, 384110
Dr Nirali Trivedi, MBBS,MD, 9937500878, drgbiswas@gmail.com
Dr Niral Trivedi, MBBS,MD
- Recruiting
Sujan Surgical Cancer Hospital and Amravati Cancer Foundation
Amravati, Maharashtra, 444606
Dr. Rajendrasingh Arora, 9823097573, rsaroradr@gmail.com
- Recruiting
KLES Dr Prabhakar Kore Hospital and MRC
Belagavi, Karnataka, 590010
Dr. Rohan Bhise, 9448866712, rohanbhise30@gmail.com
- Recruiting
Sparsh Hospital and Critical Care (P) Ltd.
Bhubaneswar, Odisha, 751007
Dr. Ghanashyam Biswas, 9937500878, drgbiswas@gmail.com
- Recruiting
Post Graduate Institute of Medical Education & Research,
Chandigarh, Chandigarh, 160012
Gaurav Prakash, 9914209678, drgp04@gmail.com
- Recruiting
Rajiv Gandhi Cancer Institute and Research Centre
Delhi, National Capital Territory of Delhi, 110085
Narendra Agrawal, MBBS, 9868764808, narendra_ag1@rediffmail.com
- Recruiting
All India Institute of Medical Sciences
Delhi, New Delhi, 10029
Dr Deepam Pushpam, 9650629370, deepampushpam@gmail.com
- Recruiting
MNJ Institute of Oncology & Regional Cancer Centre
Hyderabad, Telangana, 500004
Dr. P. K. Chaithanya, MBBS, 8897199994, mnjiorccchaithanya@gmail.com
- Recruiting
Amrita Institute of Medical Sciences (AIMS)
Kochi, Kerala, 682041
Neeraj Siddhartan, MBBS, 9946047464, neerajsidharthan@aims.amrita.edu
- Recruiting
Dr. Bafna's Star Superspeciality Clinic & Hospital
Kolhāpur, Maharashtra, 416005
Dr Varun Bafna, DNB (Hematology), 9066565353, drvarunbafna6@gmail.com
Dr Varun Bafna, DNB (Hematology)
- Recruiting
Kolhapur Cancer Centre
Kolhāpur, Maharashtra, 416234
Yogesh Anap, MBBS, 9420635556, yogesh.anap1@gmail.com
- Recruiting
Tata Medical Center
Kolkata, West Bengal, 700160
Arijit Nag, MBBS, 9051121161, javvidmd@gmail.com
- Recruiting
Mumbai Onco Care Centre
Mumbai, Maharashtra, 400056
Ashish Joshi, MBBS, 9324378234, ashjoshi44@mocindia.co.in
- Recruiting
All India Institute of Medical Sciences
Nagpur, Maharashtra, 441108
Vishvdeep Khushoo, MBBS, 9903559446, vkhushoo@gmail.com
- Recruiting
HCG Manavata Cancer Centre
Nashik, Maharashtra, 422002
Dr. Rajesh Nagarkar, 9823061929, drraj@manavatacancercentre.com
- Recruiting
Deenanath Mangeshkar Hospital & Research Center
Pune, Maharashtra, 411004
Chetan Deshmukh, MBBS, 9850811449, drchetandeshmukh@gmail.com
- Recruiting
Sahyadri Super Specialty Hospital
Pune, Maharashtra, 411006
Dr Shashikant Apte, MBBS,MD, 9822404983, shashikant.apte@gmail.com
Dr Shashikant Apte, MBBS,MD
- Recruiting
Sushrut Hospital
Pune, Maharashtra, 411038
Dr. P.K. Chaithanya, 9552544910, drpreshma@gmail.com
- Recruiting
Armed Forces Medical College
Pune, Maharashtra, 41140
Dr Uday Yanamandra, MBBS,MD, 8195035551, udayj2@gmail.com
Dr Uday Yanamandra, MBBS,MD
- Recruiting
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
Rohtak, Haryana, 124001
Dr Sudhir Atri, MBBS,DM, 9315895272, ssmantri74@yahoo.com
Dr Sudhir Atri, MBBS,DM
- Recruiting
Super Specialty Hospital (G.M.C) Srinagar
Srinagar, Jammu and Kashmir, 190010
Javvid Muzamil, MBBS, 7006787372, javvidmd@gmail.com
- Recruiting
Unique Hospital
Surat, Gujarat, 395002
Dr. Ankit Patel, 9825404202, drankitoncologist@gmail.com
- Recruiting
Kiran Multi Speciality Hospital
Surat, Gujarat, 395004
Dr. Anshul Agarwal, 8657068668, drankitoncologist@gmail.com
- Recruiting
Sunact Cancer Institute Pvt. Ltd
Thane, Maharashtra, 400615
Dr Ashay Karpe, MBBS, 9029083054, ashayoncology@gmail.com
Dr Ashay Karpe, MBBS
- Recruiting
Omega Cancer Hospitals
Visakhapatnam, Andhra Pradesh, 530040
Dr Bellala Ravishankar, 9849123256, dr.bellalaravishankar@gmail.com
About this study
Official title: A Phase 1, Open Label, Dose Escalation, Dose Expansion, Multicenter Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of Oral AUR108 in Patients With Relapsed Advanced Lymphomas(ASHA-1)
An open-label, first-in-human, Phase 1 study in adult patients with relapsed advanced lymphomas will be done to assess AUR108 safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose.
Read the detailed description
This is a Phase I, Open Label, Dose-Escalation, First-in-Human study in adult patients with select relapsed advanced lymphomas. The safety and tolerability of oral AUR108 will be evaluated in patients with Non-Hodgkin lymphoma and Hodgkin lymphoma who do not have any available curative or life-prolonging treatment options and have exhausted all effective locally available therapies. The traditional 3+3 design for dose escalation will be used to evaluate the safety, pharmacokinetics/pharmacodynamics, and determine the Optimal Biological Dose of AUR108 as a single agent. The Optimal Biological Dose will be selected using a totality of safety, PK, and PD data.
- Conditions
- Relapsed Advanced Lymphomas
- Being tested
- AUR108
- Keywords
- Relapse Advanced Lymphomas, Diffuse large B-cell lymphoma, Follicular lymphoma, Mature T/NK-cell lymphomas, Other Hodgkin lymphoma
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AUR108Drug
3 Days dosing, and 4 days no dose in a week
| Study group | Role | What they receive |
|---|---|---|
| AUR108, 50mg to 300mg | Experimental | Currently, planned dose levels are 50,90,150,220,300 mg will be administered in 3+/4- regimen. Receives: Drug: AUR108 |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. First cycle Dose Limiting Toxicities (DLT)
Assess dose limiliting toxicities of AUR108
Measured: 28 Days
Safety of AUR108 as measured by the number of participants with treatment-related adverse events (AE) graded according to NCI CTCAE version 5.0
Number of participants with TEAEs
Measured: Through study completion, an average of 1 year
Pharmacokinetics Maximum Concentration (Cmax)
Maximum Concentration of AUR108
Measured: Day 1 and Day 17
Pharmacokinetics: Time to Maximum concentration (Tmax)
Tmax in hours
Measured: Day 1 and Day 17
Pharmacokinetics: Area under the curve (AUC)
Area under the curve (AUC) of AUR108 in h* ng/mL
Measured: Day 1 and Day 17
Pharmacokinetics: Terminal elimination half-life
Terminal elimination half-life of AUR 108 in hours
Measured: Day 17
Maximum concentration (Cmax) administered under fasting/fed condition
Compare in fast and fed conditions
Measured: Day 8
Time to Maximum concentration (Tmax) administered under fasting/fed condition
Compare Tmax in fast and fed conditions
Measured: Day 8
Area under curve (AUC) administered under fasting/fed condition
Compare AUC in fast and fed conditions
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start19 Oct 2023
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Advanced LymphomasStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Sequential Assignment Dose Escalation "3+3" Design
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aurigene Discovery Technologies Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Akhil Kumar, Principal investigator, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984147
- Sponsor's protocol ID
- AUR108-101
- Acronym
- ASHA-1
- Status last verified
- Jan 2026
- First submitted
- 20 Jul 2023
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Dose Escalation, Dose Expansion, Multicenter Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of Oral AUR108 in Patients With Relapsed Advanced Lymphomas(ASHA-1)
- ClinicalTrials.gov ID
- NCT05984147
- Acronym / sponsor ID
- ASHA-1 / AUR108-101
- Conditions
- Relapsed Advanced Lymphomas
- Keywords
- Relapse Advanced Lymphomas, Diffuse large B-cell lymphoma, Follicular lymphoma, Mature T/NK-cell lymphomas, Other Hodgkin lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aurigene Discovery Technologies LimitedIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 9 Aug 2023 (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.
An open-label, first-in-human, Phase 1 study in adult patients with relapsed advanced lymphomas will be done to assess AUR108 safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose.
Detailed description
This is a Phase I, Open Label, Dose-Escalation, First-in-Human study in adult patients with select relapsed advanced lymphomas. The safety and tolerability of oral AUR108 will be evaluated in patients with Non-Hodgkin lymphoma and Hodgkin lymphoma who do not have any available curative or life-prolonging treatment options and have exhausted all effective locally available therapies. The traditional 3+3 design for dose escalation will be used to evaluate the safety, pharmacokinetics/pharmacodynamics, and determine the Optimal Biological Dose of AUR108 as a single agent. The Optimal Biological Dose will be selected using a totality of safety, PK, and PD data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sequential Assignment Dose Escalation "3+3" Design
| Arm | Type | Receives |
|---|---|---|
| AUR108, 50mg to 300mg | Experimental | Drug: AUR108Currently, planned dose levels are 50,90,150,220,300 mg will be administered in 3+/4- regimen. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Males or females ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1
- Acceptable bone marrow and organ function at screening as described below:
- Ability to swallow and retain oral medications
- Histo-pathological diagnosis of a Non-Hodgkin lymphoma orHodgkin Lymphoma. Note: The lymphoma should be either in Stage III or IV according to Lugano classification (Cheson BD et al, 2014) at screening.
Key exclusion criteria (25 listed)
- Systemic anti-cancer therapy, such as chemotherapy, or biological therapy, 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 low dose prednisone (up to 10 mg/day) is allowed.
- Presence of an acute or chronic toxicity resulting from prior anticancer treatment, with the exception of alopecia or nail changes, that has not resolved to Grade ≤ 1, as determined by NCI CTCAE v 5.0.
- Definitive Radiotherapy within the last 21 days of Cycle 1 Day 1 (limited field palliative radiation is allowed and no restrictions during the screening period or during the trial).
- Use of any investigational agent within 28 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
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 |
|---|---|---|
| AUR1083 Days dosing, and 4 days no dose in a week | Drug | AUR108, 50mg to 300mg |
Primary outcome
1. First cycle Dose Limiting Toxicities (DLT)
Time frame: 28 Days
Assess dose limiliting toxicities of AUR108
Safety of AUR108 as measured by the number of participants with treatment-related adverse events (AE) graded according to NCI CTCAE version 5.0
Time frame: Through study completion, an average of 1 year
Number of participants with TEAEs
Pharmacokinetics Maximum Concentration (Cmax)
Time frame: Day 1 and Day 17
Maximum Concentration of AUR108
Pharmacokinetics: Time to Maximum concentration (Tmax)
Time frame: Day 1 and Day 17
Tmax in hours
Pharmacokinetics: Area under the curve (AUC)
Time frame: Day 1 and Day 17
Area under the curve (AUC) of AUR108 in h* ng/mL
Pharmacokinetics: Terminal elimination half-life
Time frame: Day 17
Terminal elimination half-life of AUR 108 in hours
Maximum concentration (Cmax) administered under fasting/fed condition
Time frame: Day 8
Compare in fast and fed conditions
Time to Maximum concentration (Tmax) administered under fasting/fed condition
Time frame: Day 8
Compare Tmax in fast and fed conditions
Area under curve (AUC) administered under fasting/fed condition
Time frame: Day 8
Compare AUC in fast and fed conditions
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 17 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Akhil Kumar principal investigator
Chief Medical Officer
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AUR108 in people with Relapsed Advanced Lymphomas, run by Aurigene Discovery Technologies Limited at 27 sites in India.
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 18 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in India. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Suchit Kumbhare (+918104730078, suchit_k@aurigene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. First cycle Dose Limiting Toxicities (DLT) (time frame: 28 Days). The study lists 9 primary outcomes in all. 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 17 Apr 2026.