A Study Evaluating the Safety and Efficacy of AUR107 in Patients With Relapsed Advanced Malignancies (SHAKTI-1)

April 14, 2026 updated by: Aurigene Discovery Technologies Limited

A Phase 1, Open Label, Dose Escalation, Dose Expansion, Multicenter, First in Human Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Oral AUR107 in Patients With Relapsed Advanced Malignancies (SHAKTI-1)

An open-label, first-in-human, Phase 1 study in adult patients with relapsed advanced malignancies will be done to assess AUR107 safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase I, Open Label, Dose-Escalation, First-in-Human study in adult patients with select relapsed advanced malignancies. The safety and tolerability of oral AUR107 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 the safety, pharmacokinetics/pharmacodynamics, and determine the Optimal Biological Dose of AUR107 as a single agent. The Optimal Biological Dose will be selected using a totality of safety, PK, and PD data.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
    • Andhra Pradesh
      • Vijayawada, Andhra Pradesh, India, 520002
        • Not yet recruiting
        • HCG City Cancer Centre
        • Contact:
      • Visakhapatnam, Andhra Pradesh, India, 530040
        • Recruiting
        • Omega Hospital
        • Contact:
    • Chandigarh
      • Chandigarh, Chandigarh, India, 160012
        • Recruiting
        • Post-Graduate Institute of Medical Education and Research(PGIMER)
        • Contact:
        • Principal Investigator:
          • Dr Gaurav Prakash
    • Gujarat
      • Ahmedabad, Gujarat, India, 382428
        • Recruiting
        • Apollo Hospital International Limited
        • Contact:
        • Principal Investigator:
          • Dr Velu Nair
      • Surat, Gujarat, India, 395002
        • Recruiting
        • Unique Hospital Multispeciality and Research Institute
        • Contact:
      • Surat, Gujarat, India, 395001
        • Recruiting
        • Universal Superspeciality Hospital
        • Contact:
        • Principal Investigator:
          • Dr Amme Patel, MBBS
      • Surat, Gujarat, India, 395004
        • Recruiting
        • Kiran Hospital Multi Super Speciality Hospital & Research Centre
        • Contact:
        • Principal Investigator:
          • Dr Priyanka Das
    • Haryana
      • Rohtak, Haryana, India, 124001
        • Recruiting
        • Pt.B.D Sharma PGIMS Rohtak
        • Contact:
        • Principal Investigator:
          • Dr Sudhir Kumar Antri, MBBS
    • Karnataka
      • Bangalore, Karnataka, India, 560027
        • Recruiting
        • Healthcare Global Enterprises Ltd
        • Contact:
        • Principal Investigator:
          • Dr Nataraj KS
      • Bangalore, Karnataka, India, 560066
        • Recruiting
        • Vydehi Institute of Medical Sciences and Research Centre
        • Contact:
      • Bangalore, Karnataka, India, 560004
        • Active, not recruiting
        • Sri Shankara Cancer Hospital and Research Centre
      • Bangalore, Karnataka, India, 560064
        • Recruiting
        • Cytecare Hospitals Pvt. Ltd
        • Contact:
        • Principal Investigator:
          • Dr Harish P
      • Bangalore, Karnataka, India, 590010
        • Recruiting
        • KLEs Dr. Prabhakar Kore Hospital & Medical Research Center
        • Contact:
        • Principal Investigator:
          • Dr Rohan Bhise
      • Mysore, Karnataka, India, 570001
        • Recruiting
        • K R Hospital
        • Contact:
    • Maharashtra
      • Aurangabad, Maharashtra, India, 431001
        • Recruiting
        • Krupamayi Hospital
        • Contact:
      • Kolhāpur, Maharashtra, India, 416234
      • Nagpur, Maharashtra, India, 440001
        • Recruiting
        • KIMS-Kingsway Hospitals
        • Contact:
        • Principal Investigator:
          • Dr Riya Ballikar
      • Nagpur, Maharashtra, India, 440012
        • Recruiting
        • Rhythm Heart And Critical Care
        • Contact:
        • Principal Investigator:
          • Dr Rahul Darshan Arora, MBBS
      • Nagpur, Maharashtra, India, 440015
        • Recruiting
        • Treat Me Hospital
        • Contact:
        • Principal Investigator:
          • Dr Shriram Kane, MBBS
      • Nashik, Maharashtra, India, 422002
        • Recruiting
        • HCG Manavata Cancer Centre
        • Contact:
        • Principal Investigator:
          • Dr Raj Nagarkar Vasanthrao
      • Nashik, Maharashtra, India, 422001
        • Recruiting
        • Soham Hospital
        • Contact:
        • Principal Investigator:
          • Dr Nilesh Wasekar, MBBS
      • Navi Mumbai, Maharashtra, India, 400703
        • Recruiting
        • Cancure Day Care Centre
        • Contact:
        • Principal Investigator:
          • Dr Shishir N Shetty
      • Navi Mumbai, Maharashtra, India, 410210
        • Recruiting
        • The Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
        • Contact:
        • Principal Investigator:
          • Dr Anbarasan Sekar
      • Pune, Maharashtra, India, 411001
        • Recruiting
        • Grant Medical Foundation Ruby Hall Clinic
        • Contact:
      • Pune, Maharashtra, India, 411014
        • Recruiting
        • Novo Solitaire Care
        • Contact:
        • Principal Investigator:
          • Dr Mohite Aniket Balasaheb, MBBS
      • Pune, Maharashtra, India, 411004
        • Active, not recruiting
        • MMFHA Joshi Hospital
      • Pune, Maharashtra, India, 530040
        • Recruiting
        • Onco-Life Cancer Centre
        • Contact:
        • Principal Investigator:
          • Dr Sarang Waghmare, MBBS
      • Thane, Maharashtra, India, 400615
        • Recruiting
        • Sunact Cancer Institute Pvt Ltd
        • Contact:
        • Principal Investigator:
          • Dr Vijay Patil
    • New Delhi
      • New Delhi, New Delhi, India, 110017
        • Recruiting
        • Max Super Speciality Hospital
        • Contact:
        • Principal Investigator:
          • Dr Rayaz Ahmed
      • New Delhi, New Delhi, India, 110029
        • Recruiting
        • All India Institute of Medical Sciences
        • Contact:
    • Odisha
      • Bhubaneswar, Odisha, India, 751007
        • Recruiting
        • Sparsh Hospital & Critical care(P) LTD
        • Contact:
        • Principal Investigator:
          • Dr Ghanashyam Biswas
    • Puducherry
      • Puducherry, Puducherry, India, 605006
        • Recruiting
        • Jawaharlal Institute of Postgraduate Medical Education and Research
        • Contact:
        • Principal Investigator:
          • Dr Biswajeet Dubasi
    • Telangana
      • Hyderabad, Telangana, India, 500034
        • Recruiting
        • Basavatarakam Indo American Cancer Hospital & Research Institute
        • Contact:
        • Principal Investigator:
          • Dr Pallavi Suresh jajupallavi794@gmail.com
      • Hyderabad, Telangana, India, 500033
        • Recruiting
        • Apollo Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Dr Padmaja Lokireddy
    • West Bengal
      • Kolkata, West Bengal, India, 700160
        • Recruiting
        • Tata Medical Center
        • Contact:
        • Principal Investigator:
          • Dr Jeevan Kumar, MBBS
      • Kolkata, West Bengal, India, 700053
        • Recruiting
        • BP Poddar Hospital & Medical Research Ltd
        • Contact:
        • Principal Investigator:
          • Dr Prashant Pandey
      • Kolkata, West Bengal, India, 9830115905
        • Recruiting
        • Chittaranjan National Cancer Institute
        • Contact:
        • Principal Investigator:
          • Dr Kalyan Kusum Mukherjee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AUR107, 5mg to 200mg
Currently, planned dose levels are 5 mg QD, 10 mg QD, 20 mg QD, 40 mg QD, 60 mg QD, 90 mg QD, 135 mg QD, and 200 mg QD
Drug: AUR107
Once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First cycle Dose Limiting Toxicities (DLT)
Time Frame: 28 days
Assess dose limiliting toxicities of AUR107
28 days
Safety of AUR107 as measured by the number of participants with treatment-related adverse events (AE) graded according to NCI CTCAE version 5.0
Time Frame: 28 days
The assessment of safety was based on the frequency of deaths, AEs, SAEs, AEs leading to discontinuation of study drug, and abnormalities in specific clinical laboratory assessments. AEs and laboratory values will be graded for severity according to the NCI CTCAE version 5.0.
28 days
Optimal Biological Dose
Time Frame: 28 days
Determine optimal Biological dose
28 days
Pharmacokinetics: Maximum concentration (Cmax)
Time Frame: Day 1 and Day 15
Maximum concentration of AUR107
Day 1 and Day 15
Pharmacokinetics: Time to Maximum concentration (Tmax)
Time Frame: Day 1 and Day 15
Tmax in hours
Day 1 and Day 15
Pharmacokinetics: Area under the curve (AUC)
Time Frame: Day 1 and Day 15
Area under the curve (AUC) of AUR 107 in h* mcg/mL
Day 1 and Day 15
Pharmacokinetics: Mean Residence Time (MRT)
Time Frame: Day 1 and Day 15
Average time the drugs stays in the body
Day 1 and Day 15
Pharmacokinetics: Terminal elimination half-life
Time Frame: Day 1 and Day 15
Terminal elimination half-life of AUR 107 in hours
Day 1 and Day 15
Maximum concentration (Cmax) administered under fasting/fed condition
Time Frame: Day 8 and Day 9
Compare in fast and fed conditions
Day 8 and Day 9
Time to Maximum concentration (Tmax) administered under fasting/fed condition
Time Frame: Day 8 and Day 9
Compare Tmax in fast and fed conditions
Day 8 and Day 9
Area under curve (AUC) administered under fasting/fed condition
Time Frame: Day 8 and Day 9
Compare AUC in fast and fed conditions
Day 8 and Day 9

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory endpoint: Identification of gene expression profiles
Time Frame: Day 1, Day 2, and Day 15
Pharmacodynamic marker: Gene Expression profile as assessed by RNA analysis
Day 1, Day 2, and Day 15
Exploratory endpoint- Efficacy assessments, Overall Response Rate
Time Frame: Through study completion, an average of 1 year
Efficacy assessments-Overall Response Rate
Through study completion, an average of 1 year
Exploratory endpoint- Efficacy assessments, Duration of Response
Time Frame: Through study completion, an average of 1 year
Efficacy assessments- Duration of Response
Through study completion, an average of 1 year
Exploratory endpoint- Efficacy assessments, Progression Free Survival (PFS)
Time Frame: Through study completion, an average of 1 year
Efficacy assessments- Progression Free Survival (PFS)
Through study completion, an average of 1 year
Median Change from Baseline to End of Treatment in Tumor-Specific Markers, CA-125 in ovarian cancer
Time Frame: Through study completion, an average of 1 year
Change in Tumor Specific Markers - CA-125 in ovarian cancer
Through study completion, an average of 1 year
Median Change from Baseline to End of Treatment in Tumor-Specific Markers, PSA in Castrate Resistant Prostate Cancer
Time Frame: Through study completion, an average of 1 year
Change in Tumor Specific Markers - PSA in Castrate Resistant Prostate Cancer
Through study completion, an average of 1 year
Median Change from Baseline to End of Treatment in Tumor-Specific Markers, CEA in colorectal cancer
Time Frame: Through study completion, an average of 1 year
Change in Tumor Specific Markers - CEA in colorectal cancer
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aurigene Discovery Technologies Limited

Investigators

  • Principal Investigator: Akhil Kumar, Aurigene Oncology Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2023

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

April 28, 2023

First Submitted That Met QC Criteria

May 9, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUR107-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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