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New pill aims to tame advanced lymphomas in early trial

NCT ID NCT05984147

Disease control Sponsor: Aurigene Discovery Technologies Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tests an experimental oral drug called AUR108 in adults with relapsed advanced lymphomas. The main goals are to check the drug's safety, find the right dose, and see how the body processes it. About 40 participants will take the pill, and researchers will monitor side effects and drug levels in the blood.

Why investors are watching

Dr. Reddy's Laboratories, through its subsidiary Aurigene Discovery Technologies, is running a first-in-human Phase 1 trial of an oral drug called AUR108 in patients with relapsed advanced lymphomas. For a small-cap company, this early-stage readout matters because it is the first test of whether the drug is safe and tolerable in people, and a clear result could shape the drug's future development path.

If it works: A positive safety and tolerability result could allow Aurigene to move AUR108 into later-stage testing, potentially adding a new oncology asset to Dr. Reddy's pipeline. It could also validate the company's research approach in a competitive field.

If it fails: Phase 1 trials often fail because the drug proves unsafe or poorly tolerated, and this one is no exception. A failure or delay could set back the program and raise questions about the value of Aurigene's early-stage research.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Males or females ≥ 18 years of age 2. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1 3. Acceptable bone marrow and organ function at screening as described below: 1. ANC ≥ 1000/μL (without WBC growth factor support) 2. Platelet count ≥ 75,000/μL without transfusion support 3. Hemoglobin ≥ 9 g/dL (Transfusion is allowed to achieve this Hb) 4. Total Bilirubin ≤ 1.5 x ULN; (Patients with known Gilbert's syndrome are allowed with a Total Bilirubin ≤ 2.5 x ULN) 5. AST (SGOT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases) 6. ALT (SGPT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases) 7. 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 \[kg\] × \[0.85 if Female\] / \[72 × serum creatinine (mg/dL)\]). 4. Ability to swallow and retain oral medications 5. 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. 6. 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. 7. 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. 8. Evidence of measurable disease as per Lugano Criteria for Lymphoma (Cheson BD et al, 2014). 9. Standard curative measures do not exist, and patient must have exhausted all effective therapies, available locally. 1. 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. 2. Any cancer patient with access to any effective therapy must not be enrolled. Exclusion Criteria: 1. 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. 2. 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. 3. 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). 4. Use of any investigational agent within 28 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1. 5. Patients with cutaneous lymphomas, mycosis fungoides (MF) or Sézary syndrome (SS). 6. Primary CNS lymphoma 7. 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 8. Patients with lymphoma that requires immediate cytoreductive therapy 9. Patients with lymphoma that requires immediate cytoreductive therapy 10. Patients on the drugs which are sensitive substrates of CYP2C8 and cannot be discontinued at least one week prior to Cycle 1 Day 1 11. 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 12. Major surgery ≤ 28 days from Cycle 1 Day 1 (major surgery is defined as a procedure requiring general anesthesia) 13. 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. 14. Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome-related illness 15. Known active or chronic hepatitis B (HbsAg +ve) or hepatitis C infection (HCV antibody +ve) 16. The patient who is expected to require any other form of antineoplastic therapy or targeted therapy while on study. 17. 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 18. Ongoing cardiac dysrhythmias requiring treatment of any grade or treatment of cardiac dysrhythmias in past 3 months, before Cycle 1 Day 1. 19. QTc (Bazzett) interval \>460 ms on ECG at screening and/or at Cycle 1 Day 1 pre-dose. 20. 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 21. 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. 22. 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. 23. Positive pregnancy test for women of child-bearing potential (WOCBP) at the screening or enrolment visit 24. 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).

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Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma follicular lymphoma Hodgkins lymphoma non-Hodgkin lymphoma T-cell non-Hodgkin lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsed advanced lymphomas

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    27 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • All India Institute of Medical Sciences

    RECRUITING

    Nagpur, Maharashtra, 441108, India

  • All India Institute of Medical Sciences

    RECRUITING

    Delhi, New Delhi, 10029, India

  • Amrita Institute of Medical Sciences (AIMS)

    RECRUITING

    Kochi, Kerala, 682041, India

  • Armed Forces Medical College

    RECRUITING

    Pune, Maharashtra, 41140, India

  • Cellcure Care Cancer Pvt Ltd

    RECRUITING

    Ahmedabad, Gujarat, 380009, India

  • Deenanath Mangeshkar Hospital & Research Center

    RECRUITING

    Pune, Maharashtra, 411004, India

  • Dr. Bafna's Star Superspeciality Clinic & Hospital

    RECRUITING

    Kolhāpur, Maharashtra, 416005, India

  • HCC Happiness Care and Cure Multispeciality Hospital

    RECRUITING

    Ahmedabad, Gujarat, 380015, India

  • HCG Manavata Cancer Centre

    RECRUITING

    Nashik, Maharashtra, 422002, India

  • KLES Dr Prabhakar Kore Hospital and MRC

    RECRUITING

    Belagavi, Karnataka, 590010, India

  • Kiran Multi Speciality Hospital

    RECRUITING

    Surat, Gujarat, 395004, India

    Contact Email: •••••@•••••

  • Kolhapur Cancer Centre

    RECRUITING

    Kolhāpur, Maharashtra, 416234, India

  • MNJ Institute of Oncology & Regional Cancer Centre

    RECRUITING

    Hyderabad, Telangana, 500004, India

  • Mumbai Onco Care Centre

    RECRUITING

    Mumbai, Maharashtra, 400056, India

  • Omega Cancer Hospitals

    RECRUITING

    Visakhapatnam, Andhra Pradesh, 530040, India

  • Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences

    RECRUITING

    Rohtak, Haryana, 124001, India

  • Post Graduate Institute of Medical Education & Research,

    RECRUITING

    Chandigarh, Chandigarh, 160012, India

  • Rajiv Gandhi Cancer Institute and Research Centre

    RECRUITING

    Delhi, National Capital Territory of Delhi, 110085, India

  • Sahyadri Super Specialty Hospital

    RECRUITING

    Pune, Maharashtra, 411006, India

  • Shankus Hospital Pvt. Ltd.

    RECRUITING

    Ahmedabad, Gujarat, 384110, India

  • Sparsh Hospital and Critical Care (P) Ltd.

    RECRUITING

    Bhubaneswar, Odisha, 751007, India

  • Sujan Surgical Cancer Hospital and Amravati Cancer Foundation

    RECRUITING

    Amravati, Maharashtra, 444606, India

  • Sunact Cancer Institute Pvt. Ltd

    RECRUITING

    Thane, Maharashtra, 400615, India

  • Super Specialty Hospital (G.M.C) Srinagar

    RECRUITING

    Srinagar, Jammu and Kashmir, 190010, India

  • Sushrut Hospital

    RECRUITING

    Pune, Maharashtra, 411038, India

  • Tata Medical Center

    RECRUITING

    Kolkata, West Bengal, 700160, India

  • Unique Hospital

    RECRUITING

    Surat, Gujarat, 395002, India

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