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Select Relapsed/Refractory Lymphoid MalignanciesPhase 1VIJAY-1NCT06761586

A Study of AUR104 in Patients With Relapsed/Refractory Lymphoid Malignancies (VIJAY-1)

A Phase 1 study testing AUR104 in people with Select Relapsed/Refractory Lymphoid Malignancies, run by Aurigene Discovery Technologies Limited at 5 sites in India.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a multicenter, open-label, Phase 1 study of AUR104 in adult patients with select Relapsed/Refractory (R/R) Lymphoid Malignancies. The main objective of the study is to evaluate the safety and tolerability of the study drug AUR104.In this study, safety, tolerability, pharmacokinetics, pharmacodynamics, and… Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
AUR104
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
5 sitesIndia
Study dates
12 Dec 2024to 10 Feb 2026
Phase
Phase 1
Are there results?
None posted in the registry

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 and 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: For patients with CLL ≥ 50,000/μL, For patients with lymphomas ≥ 75,000/μL without bone marrow involvement and ≥ 50,000/μL with bone marrow involvement. These thresholds should be qualified without current 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) ≥ 60 mL/min (either measured or estimated by the Cockcroft-Gault formula). Cockcroft-Gault formula for estimated creatinine clearance (eCrCl):(140 - Age) × Weight (kg) × (0.85 if Female)/(72 × serum creatinine in mg/dL).
  • Ability to swallow and retain oral medications.
  • Histopathological diagnosis of Non-Hodgkin Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL) or Hodgkin disease.
  • Note:
  • 5a. The lymphoma should be either in Stage III or IV according to Lugano classification at screening.
  • 5b. The lymphomas included in this study must fall within one of the following 2017 World Health Organization categories except lymphoma mentioned in Exclusion criterion #5:
  • Mature B-cell neoplasms (excluding plasma cell neoplasms, heavy chain disease, and primary central nervous system [CNS] lymphoma).
  • Mature T- and NK-cell neoplasms.
  • Hodgkin lymphomas. 5c. The CLL should be Binet Stage C/Rai stage III or IV, as per the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines.
  • 6) In the case of patients who have lymphoid malignancies for which high-dose chemotherapy and autologous stem cell transplantation (HD-ASCT) is considered standard curative therapy, eligibility for this study requires that the disease has relapsed after HD-ASCT, or the subject is not eligible for HD-ASCT, or the subject has refused HD-ASCT.
  • 7) In the case of patients who have lymphoid malignancies for which CAR-T therapy is indicated, eligibility for this study requires that the disease has relapsed after CAR-T, or the patient is not eligible for CAR-T, or the patient has refused CAR-T, or the CAR-T is not available locally.
  • 8) Evidence of measurable disease as per Lugano Criteria for Lymphoma or evidence of measurable disease as per iwCLL Criteria for CLL.
  • Note: Patients with Small Lymphocytic Lymphoma (SLL) alone or in combination with CLL are allowed.
  • 9) Standard curative measures do not exist, and the patient must have exhausted all effective therapies available locally. At a minimum, the patients must have relapsed or refractory disease to at least 2 prior lines of systemic therapies for NHL or CLL, or Hodgkin's disease.
  • Note: Any cancer patient with access to any effective therapy locally must not be enrolled.

Who cannot join

  • 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) is allowed.
  • Presence of acute or chronic toxicity resulting from prior anti-cancer treatment, except for alopecia or nail changes that have 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 Burkitt's lymphoma, Burkitt-like lymphoma, post-transplant lymphoproliferative disease, primary mediastinal large-B cell lymphoma, cutaneous lymphomas, mycosis fungoides (MF), or Sezary syndrome (SS).
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  • Known symptomatic or untreated or recently treated (≤ 6 months of screening) central nervous system (CNS) lymphoma. Patients with previously treated (more than 6 months of screening) CNS lymphoma and are now stable and asymptomatic, from a CNS perspective, are allowed.
  • Patients with lymphoma requiring immediate cytoreductive therapy.
  • Patients with low-grade or indolent lymphoma not meeting conventional criteria for treatment.
  • Elevated Serum cardiac Troponin I or troponin T more than ULN at screening.
  • Serum magnesium and calcium levels more than 1.2 x ULN or less than 0.8 x LLN.
  • Serum Potassium more than 1.0 x ULN or less than 1.0 x LLN. Note: Patients experiencing hypokalemia are permitted to undergo treatment to attain normal potassium levels during the screening period.
  • Mean Heart Rate less than 60 at screening or Cycle 1 Day 1 (to be recorded at least 3 times at least 5 minutes apart) in ECG.
  • Left ventricular ejection fraction (LVEF) less than 50% as determined by an echocardiogram (ECHO) or Multigated Acquisition (MUGA) scan.
  • QTcF (Fridericia) interval more than 450 ms for patients on ECG at screening and/or at Cycle 1 Day 1.
  • Uncontrolled arterial hypertension defined as supine SBP of ≥ 140 mm Hg AND/OR supine DBP ≥ 90 mmHg on stable doses of three or lesser different classes of antihypertensive drugs.
  • Notes:
  • Patients taking 4 or more classes of antihypertensives are excluded. Diuretics (such as furosemide or spironolactone) are considered as one class of anti-hypertensives.
  • The blood pressure has to be recorded 3 times at least 10 minutes apart during Screening and Cycle 1 Day 1 (before dosing) in the supine position. Among these recordings, a single instance of SBP ≥140 mm Hg or DBP ≥ 90 mmHg will exclude the patient. Note: A patient excluded on these criteria can be re-screened after optimal BP management.
  • Current or past history of heart failure (NYHA Class 2 or higher)
  • Having a history of moderate to severe cardiovascular disease including unstable angina, myocardial infarction, cerebrovascular accident, or transient ischemic attack (TIA), within 1 year prior to Cycle 1 Day 1.
  • Ongoing cardiac arrhythmias or conduction blocks.
  • History of any ventricular arrhythmia including supraventricular or ventricular premature contractions.
  • Patients on drugs which are sensitive substrates of CYP3A4 and cannot be discontinued at least one week prior to Cycle 1 Day 1.
  • Use of strong CYP3A4 inhibitors or inducers within 2 weeks prior to Cycle 1 Day 1.
  • Concomitant use of any drug which is known to prolong QTc interval or use of such drugs within 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 the screening period, which is resolved adequately according to the investigator before 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).
  • Patient expected to require any other form of antineoplastic therapy or targeted therapy while in the study.
  • Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, 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 the 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 the study drug, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ or cured early-stage (Stage 1 or 2) prostate cancer.
  • Positive pregnancy test for women of childbearing potential (WOCBP) at the screening or enrollment 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

5 sites in 1 country.

5 sites in 1 country

India5 sites

  • Kolhapur Cancer Centre Pvt. Ltd.

    Kolhāpur, Maharashtra, 416234

  • MMFHA Joshi Hospital

    Pune, Maharashtra, 411004

  • Kiran Multi Super Speciality Hospital and Research Centre

    Surat, Gujarat, 395004

  • Sunshine Global Hospitals

    Surat, Gujarat, 395007

  • Adwaita Cancer Hospital & ICU

    Surat, Gujarat, 395009

Other trials in India

About this study

Official title: A Phase 1, Open Label, Dose Escalation, Multicenter Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Oral AUR104 in Patients With Select Relapsed/Refractory Lymphoid Malignancies (VIJAY-1)

This is a multicenter, open-label, Phase 1 study of AUR104 in adult patients with select Relapsed/Refractory (R/R) Lymphoid Malignancies. The main objective of the study is to evaluate the safety and tolerability of the study drug AUR104.In this study, safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AUR104 will be evaluated in dose escalation manner.

Read the detailed description

This is a multicenter, open-label, Phase 1 study of AUR104 in adult patients with select Relapsed/Refractory (R/R) Lymphoid Malignancies. The dose escalation will be conducted in a rule-based manner in patients who do not have any available curative treatment options and have exhausted all effective therapies available locally. At a minimum, the patients must have relapsed or refractory disease to at least 2 prior lines of systemic therapies for NHL or CLL, or Hodgkin's disease. The main objective of the study is to evaluate the safety and tolerability of the study drug AUR104. In this study, safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AUR104 will be evaluated in dose escalation manner.

Being tested
AUR104
Keywords
Relapsed/Refractory Lymphoid Malignancies, Non-Hodgkin Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Hodgkin Lymphoma (HL)
Medical subject headings
Recurrence, Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AUR104Drug

    Once or twice a day

Study groups in NCT06761586
Study groupRoleWhat they receive
AUR104 5mg & 20 mg TabletsExperimentalCurrently planned dose levels are 20 mg QD, 10 mg BID and 15 mg BID.
Receives: Drug: AUR104

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. First cycle DLT

    Assess dose limiting toxicities of AUR104

    Measured: 28 days (Cycle 1)

  2. Frequency of Adverse Events

    Adverse Events will be assessed by NCI CTCAE v 5.0

    Measured: Throughout the study, an average of 1 year

  3. Frequency of Serious Adverse Events

    Serious Adverse Events will be assessed by NCI CTCAE v 5.0

    Measured: Throughout the study, an average of 1 year

  4. Pharmacokinetics: Area under the curve (AUC)

    Area under the curve of AUR104

    Measured: Cycle 1 Day 1 and Day 9 (Cohorts 1, 2, and 3); Cycle 1 Day 5 (only Cohort 3) (Each cycle is 28 days)

  5. Pharmacokinetics: Maximum plasma concentration (Cmax)

    Maximum plasma concentration of AUR104

    Measured: Cycle 1 Day 1 and Day 9 (Cohorts 1, 2, and 3); Cycle 1 Day 5 (only Cohort 3) (Each cycle is 28 days)

  6. Pharmacokinetics: Time to Maximum plasma concentration (Tmax)

    Time to Maximum plasma concentration of AUR104

    Measured: Cycle 1 Day 1 and Day 9 (Cohorts 1, 2, and 3); Cycle 1 Day 5 (only Cohort 3) (Each cycle is 28 days)

  7. Pharmacokinetics: Terminal elimination half-life (t½)

    Terminal elimination half-life of AUR104

    Measured: Cycle 1 Day 1 and Day 9 (Cohorts 1, 2, and 3); Cycle 1 Day 5 (only Cohort 3) (Each cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2025
  2. Study start12 Dec 2024
  3. Primary completion10 Feb 2026
  4. Study completion10 Feb 2026

Why it stopped: Patient recruitment problems

Resources

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 Design
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06761586
Sponsor's protocol ID
AUR104-101
Acronym
VIJAY-1
Status last verified
Apr 2026
First submitted
12 Dec 2024
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AUR104 in people with Select Relapsed/Refractory Lymphoid Malignancies, run by Aurigene Discovery Technologies Limited at 5 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 24 inclusion and 36 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: stopped early, 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 5 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?

The study was stopped early (reason given: Patient recruitment problems). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

First cycle DLT (time frame: 28 days (Cycle 1)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06761586.

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.

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