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New pill AUR107 enters first human tests for tough cancers

NCT ID NCT05865002

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 1 trial is testing an oral drug called AUR107 in 50 adults with advanced solid tumors that have come back after prior treatment. The study aims to find a safe dose and understand how the drug moves through the body. It is the first time AUR107 is being tested in humans, so the main focus is on safety and side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AUR107 (an oral drug)
What this could lead to
If this trial shows AUR107 is safe and well-tolerated, it could point toward a new treatment option for people with advanced cancers that have not responded to other therapies.
What could go wrong
This is a very early Phase 1 study with only 50 participants, so it is too soon to know if AUR107 will work. The main goal is safety, not effectiveness, and there may be side effects or no benefit.
Why investors are watching

Dr. Reddys Laboratories Limited, through its subsidiary Aurigene Discovery Technologies Limited, is running a first-in-human Phase 1 trial of an oral cancer drug called AUR107 in 50 patients with advanced cancers that have returned. This is an early test of safety and dosing, and for a small-cap company, the readout will show whether the drug is tolerable enough to keep developing. A clear safety signal could validate the company's pipeline, while a poor one could set the program back.

If it works: If AUR107 shows an acceptable safety profile and signs of disease control, Aurigene could advance the drug to later-stage trials. That would give Dr. Reddys a new experimental cancer asset with clinical data behind it.

If it fails: Phase 1 trials fail often, and most experimental cancer drugs never reach the market. If AUR107 proves too toxic or shows no benefit, the company would likely abandon the program, and the money and time spent on it would be lost.

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 50 people

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

Started

Sep 2023

Expected to finish

Jun 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 years and older

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 and 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 ≥ 1500/μL (without WBC growth factor support) 2. Platelet count ≥ 100,000/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) ≥ 60 mL/min (either measured or estimated by the Cockcroft-Gault formula). 4. Ability to swallow and retain oral medications. 5. Histopathological diagnosis of a solid tumor. Note: The solid tumors must be in Stage IV at screening. 6. Evidence of measurable disease per RECIST, v1.1 for solid tumors. 7. Standard curative measures do not exist, and the patient must have exhausted all effective therapies available locally. Notes: 7a. At a minimum, solid tumor patients must have received at least two lines of systemic therapies in the metastatic incurable settings (these two lines must be in the metastatic setting and not in the earlier stage of cancer). 7b. Any cancer patient with access to any effective therapy must not be enrolled Exclusion Criteria: 1. Systemic anti-cancer therapy, such as chemotherapy, biological therapy, or immunomodulatory drug therapy, received within the past 28 days or 5 half-lives, whichever is longer, from Cycle 1 Day 1 of the study. Note: Concomitant use of low-dose prednisone (up to 10 mg/day) or medroxyprogesterone is allowed. Note: Patients with CRPC (castrate-resistant prostate cancer) should continue to receive ongoing medical castration with LHRH analogs, and such patients are allowed. 2. Presence of 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) • Use of any investigational agent within 28 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1. 4. Use of drugs which are moderate / strong CYP3A4 inducers and/or drugs which are predominantly metabolized by CYP3A4 within 1week or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1. • Note: This class of drugs are also prohibited during DLT evaluation period and must be either avoided or used with caution beyond DLT evaluation period. 5. Known symptomatic or untreated or recently treated (≤ 6 months of screening) central nervous system (CNS) metastases. Patients with previously treated (\> 6 months of screening) CNS metastases and are now stable and asymptomatic, from CNS perspective, are allowed. 6. Major surgery ≤ 28 days from Cycle 1 Day 1 (major surgery is defined as a procedure requiring general anesthesia). 7. Patients with leukemia, myelodysplastic syndrome, multiple myeloma, or lymphoma. 8. Active infection requiring systemic therapy. Note: Prophylactic use of antibiotics is allowed. Any infection detected during the screening period which is resolved adequately according to investigator before the Cycle 1 Day 1, is allowed. 9. Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome-related illness. 10. Known active or chronic hepatitis B (HBsAg +ve) or hepatitis C infection (HCV antibody +ve). 11. The patient who is expected to require any other form of antineoplastic therapy or targeted therapy while on study. 12. 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. 13. Ongoing cardiac dysrhythmias requiring treatment of any grade or treatment of cardiac dysrhythmias in the past 3 months, before Cycle 1 Day 1. 14. QTc (Bazzett) interval \>460 ms on ECG at screening and/or at Cycle 1 Day 1 pre-dose. 15. 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. 16. 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 the person(s) with confirmed Covid-19 infection, at screening or Day 1 of Cycle 1. 17. Positive pregnancy test for women of childbearing potential (WOCBP) at the screening or enrolment visit. 18. Lactating women or WOCBP who are neither surgically sterilized nor willing to use reliable contraceptive methods. (hormonal contraceptive, IUD, or any double combination of the male or female condom, spermicidal gel, diaphragm, sponge, cervical cap).

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Conditions

The condition(s) this trial relates to.

colon carcinoma colonic neoplasm esophageal cancer Esophageal Neoplasms gastric cancer gastric neoplasm kidney cancer non-small cell lung carcinoma urothelial carcinoma

As listed by the trial registrant

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

Relapsed malignant solid neoplasm

How to take part

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

  1. The places running it

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

  2. 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 ↗

  3. 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

    New Delhi, New Delhi, 110029, India

  • Apollo Cancer Hospital

    RECRUITING

    Hyderabad, Telangana, 500033, India

  • Apollo Hospital International Limited

    RECRUITING

    Ahmedabad, Gujarat, 382428, India

  • BP Poddar Hospital & Medical Research Ltd

    RECRUITING

    Kolkata, West Bengal, 700053, India

  • Basavatarakam Indo American Cancer Hospital & Research Institute

    RECRUITING

    Hyderabad, Telangana, 500034, India

  • Cancure Day Care Centre

    RECRUITING

    Navi Mumbai, Maharashtra, 400703, India

  • Chittaranjan National Cancer Institute

    RECRUITING

    Kolkata, West Bengal, 9830115905, India

  • Cytecare Hospitals Pvt. Ltd

    RECRUITING

    Bangalore, Karnataka, 560064, India

  • Grant Medical Foundation Ruby Hall Clinic

    RECRUITING

    Pune, Maharashtra, 411001, India

  • HCG City Cancer Centre

    NOT_YET_RECRUITING

    Vijayawada, Andhra Pradesh, 520002, India

  • HCG Manavata Cancer Centre

    RECRUITING

    Nashik, Maharashtra, 422002, India

  • Healthcare Global Enterprises Ltd

    RECRUITING

    Bangalore, Karnataka, 560027, India

  • Jawaharlal Institute of postgraduate medical education and research

    RECRUITING

    Puducherry, Puducherry, 605006, India

  • K R Hospital

    RECRUITING

    Mysore, Karnataka, 570001, India

  • KLEs Dr. Prabhakar Kore Hospital & Medical Research Center

    RECRUITING

    Bangalore, Karnataka, 590010, India

  • Kims-Kingsway Hospitals

    RECRUITING

    Nagpur, Maharashtra, 440001, India

  • Kiran Hospital Multi Super Speciality Hospital & Research Centre

    RECRUITING

    Surat, Gujarat, 395004, India

  • Kolhapur Cancer Centre

    RECRUITING

    Kolhāpur, Maharashtra, 416234, India

  • Krupamayi Hospital

    RECRUITING

    Aurangabad, Maharashtra, 431001, India

  • MMFHA Joshi Hospital

    ACTIVE_NOT_RECRUITING

    Pune, Maharashtra, 411004, India

  • Max Super Speciality Hospital

    RECRUITING

    New Delhi, New Delhi, 110017, India

  • Novo Solitaire Care

    RECRUITING

    Pune, Maharashtra, 411014, India

  • Omega Hospital

    RECRUITING

    Visakhapatnam, Andhra Pradesh, 530040, India

  • Onco-Life Cancer Centre

    RECRUITING

    Pune, Maharashtra, 530040, India

  • Post-Graduate Institute of Medical Education and Research(PGIMER)

    RECRUITING

    Chandigarh, Chandigarh, 160012, India

  • Pt.B.D Sharma PGIMS Rohtak

    RECRUITING

    Rohtak, Haryana, 124001, India

  • Rhythm Heart And Critical Care

    RECRUITING

    Nagpur, Maharashtra, 440012, India

  • Soham Hospital

    RECRUITING

    Nashik, Maharashtra, 422001, India

  • Sparsh Hospital & Critical care(P) LTD

    RECRUITING

    Bhubaneswar, Odisha, 751007, India

  • Sri Shankara Cancer Hospital and Research Centre

    ACTIVE_NOT_RECRUITING

    Bangalore, Karnataka, 560004, India

  • Sunact Cancer Institute Pvt Ltd

    RECRUITING

    Thane, Maharashtra, 400615, India

  • Tata Medical Center

    RECRUITING

    Kolkata, West Bengal, 700160, India

  • The Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)

    RECRUITING

    Navi Mumbai, Maharashtra, 410210, India

  • Treat Me Hospital

    RECRUITING

    Nagpur, Maharashtra, 440015, India

  • Unique Hospital Multispeciality and Research Institute

    RECRUITING

    Surat, Gujarat, 395002, India

  • Universal Superspeciality Hospital

    RECRUITING

    Surat, Gujarat, 395001, India

  • Vydehi Institute of Medical Sciences and Research Centre

    RECRUITING

    Bangalore, Karnataka, 560066, India

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