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RelapsePhase 1JIVANNCT05861947

A Phase 1 Clinical Trial of AUR106 in Patients With Relapsed Advanced Malignancies

A Phase 1 study testing AUR106 in people with Relapse and Advanced Malignant Neoplasm, run by Aurigene Discovery Technologies Limited at 6 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

A Phase I, Open Label, Dose-Escalation, First in Human (FIH) Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AUR106 in Patients with Select Relapsed Advanced Malignancies (JIVAN). Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
AUR106
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
6 sitesIndia
Study dates
26 Aug 2023to 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

  • Provide signed and dated informed consent and agree to comply with all study related activities.
  • Male or female patients aged ≥ 18 years.
  • Patients have to meet the following criteria:
  • Pathological diagnosis of the following solid tumors: Non-small cell lung cancer, Gastric cancer, Urothelial cancer (includes bladder cancer and cancers of ureter / renal pelvis), Kidney cancer, Colon cancer, Esophageal cancer).
  • Standard curative or life prolonging measures do not exist, and patient must have exhausted all effective therapies, available locally. At a minimum, patients should have received at least 2 lines of therapy in the metastatic setting.
  • Standard treatment options provided to the patients are exhausted.
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  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Patients with disease related ECOG 2 are allowed, in addition to ECOG 0 and 1).
  • Acceptable bone marrow as described below:
  • ANC ≥ 1500/μL (without WBC growth factor support).
  • Platelet count ≥ 100,000/μL without transfusion support.
  • Hemoglobin ≥ 9 g/dL (Transfusion is allowed to achieve this Hb).
  • Acceptable organ function as described below:
  • 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]: eCrCl = [140 - Age] × Weight [kg] × [0.85 if Female] / [72 × serum creatinine (mg/dL)]).
  • Albumin ≥ 3.0 g/dL.
  • Ability to swallow and retain oral medications.
  • Negative serum pregnancy test in women of childbearing potential (WOCBP).
  • Women of childbearing potential and men who partner with such a woman of childbearing potential must agree to use one or more of highly effective method(s) of contraception for the duration of the study, i.e., through 28-day follow up visit, after discontinuation of study drug(s).
  • Evidence of measurable disease per RECIST, v1.1 for solid tumors (Eisenhauer et al. 2009). Measurable disease for solid tumors is defined as at least one lesion that can be accurately measured in at least 1 dimension with a minimum size of 10 mm for non-nodal lesions or 15 mm in short axis for nodal lesions.

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 the Cycle 1 Day 1 of the study.
  • Presence of an acute or chronic toxicity resulting from prior anti-cancer 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.
  • Known symptomatic or untreated or recently treated (≤ 6 months of screening) central nervous system (CNS) metastases. Patients with previously treated (> 6 months of screening) 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).
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  • Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome-related illness.
  • Known active or chronic hepatitis B or hepatitis C infection.
  • Uncontrolled congestive heart failure (New York Heart Association [NYHA] Class 2-4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, 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.
  • The QTcF (corrected QT interval Fridericia method) value in the screening ECG > 460 ms in both males and females.
  • Previous or concomitant additional malignancy, except for basal-cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the uterine cervix; 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.
  • Pregnant or lactating women.
  • Any clinically significant medical, psychiatric or social condition; or laboratory abnormality that may increase the risk of trial participation or may interfere with the informed consent process and/or with compliance with the requirements of the trial or may interfere with the interpretation of the trial results and, in the Investigator's opinion, would make the patient inappropriate for entry into this trial.
  • Patients who require concomitant administration of drugs which have a high risk of prolonging QT interval.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

India6 sites

  • All India Institute of Medical Sciences

    Bhubaneswar, Odisha, 751019

  • Sankalp Speciality Hospital

    Nashik, Maharashtra, 422009

  • Moraya Multispeciality Hospital (Ashwin Medical Foundations)

    Pune, Maharasthra, 411033

  • Unique Hospital Multispeciality and Research Institute

    Surat, Gujarat, 395002

  • Kiran Multi Super Specialty Hospital

    Surat, Gujarat, 395004

  • Omega Hospital

    Visakhapatnam, Andhra Pradesh, 530040

Other trials in India

About this study

Official title: A Phase I, Open Label, Dose-Escalation, First in Human (FIH) Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AUR106 in Patients With Select Relapsed Advanced Malignancies (JIVAN)

A Phase I, Open Label, Dose-Escalation, First in Human (FIH) Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AUR106 in Patients with Select Relapsed Advanced Malignancies (JIVAN).

Read the detailed description

This is a Phase I, Open Label, Dose-Escalation, First in Human (FIH) study in adult patients with select relapsed advanced malignancies. The safety and tolerability of oral AUR106 will be evaluated in patients with selected advanced solid tumors (Non-small cell lung cancer, Gastric cancer, Urothelial cancer, Kidney cancer, Colon cancer and Esophageal cancer), 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 safety, PK/PD and determine the Optimal Biological Dose (OBD) of AUR106, as a single agent. The Optimal Biological Dose will be selected using a totality of safety, PK and PD data.

Being tested
AUR106
Medical subject headings
Recurrence, Carcinoma, Non-Small-Cell Lung, Stomach Neoplasms, Carcinoma, Transitional Cell, Kidney Neoplasms, Colonic Neoplasms, Esophageal Neoplasms

What participants receive

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

  • AUR106Drug

    Once or twice daily

Study groups in NCT05861947
Study groupRoleWhat they receive
AUR106Experimental25mg to 100 mg, Currently planned dose levels are 25 mg QD, 50 mg QD, 25 mg BID, 50 mg BID, 100 mg BID
Receives: Drug: AUR106

What is being measured

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

  1. Optimal Biological Dose (OBD)

    To determine the Optimal Biological Dose (OBD) based on safety, pharmacokinetic, and pharmacodynamic data

    Measured: First 28 Days (Cycle 1)

  2. Dose Limiting Toxicity (DLT)

    To determine the DLT of AUR106

    Measured: First 28 Days (Cycle 1)

  3. Pharmacokinetics: Area under the curve (AUC)

    Area under the curve of AUR106

    Measured: Day 1 and Day 15

  4. Pharmacokinetics: Maximum concentration Pharmacokinetics: Maximum concentration

    Maximum concentration of AUR106

    Measured: Day 1 and Day 15

  5. Pharmacokinetics: Time to Maximum concentration

    Time to Maximum concentration of AUR106

    Measured: Day 1 and Day 15

  6. Pharmacokinetics: Terminal elimination half life

    Terminal elimination half life of AUR106

    Measured: Day 1 and Day 15

Secondary outcomes (2)

  1. Adverse Events

    Adverse Events as characterized by type, frequency, severity (as per CTCAE Version 5.0), timing, seriousness, and relationship to study therapy.

    Measured: Through study completion, an average of 1 year

  2. Laboratory abnormalities

    Number of participants with abnormal laboratory tests results

    Measured: Through study completion, an average of 1 year

Timeline

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

  1. First posted17 May 2023
  2. Study start26 Aug 2023
  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
Dose Escalation "3+3" Design
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05861947
Sponsor's protocol ID
AUR106-101
Acronym
JIVAN
Status last verified
Apr 2023
First submitted
25 Apr 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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AUR106 in people with Relapse and Advanced Malignant Neoplasm, run by Aurigene Discovery Technologies Limited at 6 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 21 inclusion and 15 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 6 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?

Optimal Biological Dose (OBD) (time frame: First 28 Days (Cycle 1)). The study lists 6 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 NCT05861947.

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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