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

NCT05865002 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: AUR107-101
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 37

Brief Summary

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.

Conditions

Relapsed Malignant Solid Neoplasm

Keywords

Relapse malignant neoplasm; Non small cell lung cancer; Gastric cancer; Colon cancer; Esophageal cancer; Kidney cancer

Outcome Measures

Primary Outcomes (11)

• First cycle Dose Limiting Toxicities (DLT)

  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

  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

  Determine optimal Biological dose

  28 days

• Pharmacokinetics: Maximum concentration (Cmax)

  Maximum concentration of AUR107

  Day 1 and Day 15

• Pharmacokinetics: Time to Maximum concentration (Tmax)

  Tmax in hours

  Day 1 and Day 15

• Pharmacokinetics: Area under the curve (AUC)

  Area under the curve (AUC) of AUR 107 in h\* mcg/mL

  Day 1 and Day 15

• Pharmacokinetics: Mean Residence Time (MRT)

  Average time the drugs stays in the body

  Day 1 and Day 15

• Pharmacokinetics: Terminal elimination half-life

  Terminal elimination half-life of AUR 107 in hours

  Day 1 and Day 15

• Maximum concentration (Cmax) administered under fasting/fed condition

  Compare in fast and fed conditions

  Day 8 and Day 9

• Time to Maximum concentration (Tmax) administered under fasting/fed condition

  Compare Tmax in fast and fed conditions

  Day 8 and Day 9

• Area under curve (AUC) administered under fasting/fed condition

  Compare AUC in fast and fed conditions

  Day 8 and Day 9

Other Outcomes (7)

• Exploratory endpoint: Identification of gene expression profiles

  Day 1, Day 2, and Day 15

• Exploratory endpoint- Efficacy assessments, Overall Response Rate

  Through study completion, an average of 1 year

• Exploratory endpoint- Efficacy assessments, Duration of Response

  Through study completion, an average of 1 year

Study Arms (1)

AUR107, 5mg to 200mg

EXPERIMENTAL

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

Interventions

AUR107 DRUG

Once daily

AUR107, 5mg to 200mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≥ 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)
• 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).
• Ability to swallow and retain oral medications.
• Histopathological diagnosis of a solid tumor. Note: The solid tumors must be in Stage IV at screening.
• Evidence of measurable disease per RECIST, v1.1 for solid tumors.
• Standard curative measures do not exist, and the patient must have exhausted all effective therapies available locally.
• Notes:

You may not qualify if:

• 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.
• 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.
• 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.
• 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.
• 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.
• Major surgery ≤ 28 days from Cycle 1 Day 1 (major surgery is defined as a procedure requiring general anesthesia).
• Patients with leukemia, myelodysplastic syndrome, multiple myeloma, or lymphoma.
• 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.
• 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).
• The patient who is expected to require any other form of antineoplastic therapy or targeted therapy while on study.

Sponsors & Collaborators

• Aurigene Discovery Technologies Limited: lead

Study Sites (37)

HCG City Cancer Centre

Vijayawada, Andhra Pradesh, 520002, India

NOT YET RECRUITING

Omega Hospital

Visakhapatnam, Andhra Pradesh, 530040, India

RECRUITING

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

Chandigarh, Chandigarh, 160012, India

RECRUITING

Apollo Hospital International Limited

Ahmedabad, Gujarat, 382428, India

RECRUITING

Universal Superspeciality Hospital

Surat, Gujarat, 395001, India

RECRUITING

Unique Hospital Multispeciality and Research Institute

Surat, Gujarat, 395002, India

RECRUITING

Kiran Hospital Multi Super Speciality Hospital & Research Centre

Surat, Gujarat, 395004, India

RECRUITING

Pt.B.D Sharma PGIMS Rohtak

Rohtak, Haryana, 124001, India

RECRUITING

Sri Shankara Cancer Hospital and Research Centre

Bangalore, Karnataka, 560004, India

ACTIVE NOT RECRUITING

Healthcare Global Enterprises Ltd

Bangalore, Karnataka, 560027, India

RECRUITING

Cytecare Hospitals Pvt. Ltd

Bangalore, Karnataka, 560064, India

RECRUITING

Vydehi Institute of Medical Sciences and Research Centre

Bangalore, Karnataka, 560066, India

RECRUITING

KLEs Dr. Prabhakar Kore Hospital & Medical Research Center

Bangalore, Karnataka, 590010, India

RECRUITING

K R Hospital

Mysore, Karnataka, 570001, India

RECRUITING

Krupamayi Hospital

Aurangabad, Maharashtra, 431001, India

RECRUITING

Kolhapur Cancer Centre

Kolhāpur, Maharashtra, 416234, India

RECRUITING

Kims-Kingsway Hospitals

Nagpur, Maharashtra, 440001, India

RECRUITING

Rhythm Heart And Critical Care

Nagpur, Maharashtra, 440012, India

RECRUITING

Treat Me Hospital

Nagpur, Maharashtra, 440015, India

RECRUITING

Soham Hospital

Nashik, Maharashtra, 422001, India

RECRUITING

HCG Manavata Cancer Centre

Nashik, Maharashtra, 422002, India

RECRUITING

Cancure Day Care Centre

Navi Mumbai, Maharashtra, 400703, India

RECRUITING

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

Navi Mumbai, Maharashtra, 410210, India

RECRUITING

Grant Medical Foundation Ruby Hall Clinic

Pune, Maharashtra, 411001, India

RECRUITING

MMFHA Joshi Hospital

Pune, Maharashtra, 411004, India

ACTIVE NOT RECRUITING

Novo Solitaire Care

Pune, Maharashtra, 411014, India

RECRUITING

Onco-Life Cancer Centre

Pune, Maharashtra, 530040, India

RECRUITING

Sunact Cancer Institute Pvt Ltd

Thane, Maharashtra, 400615, India

RECRUITING

Max Super Speciality Hospital

New Delhi, New Delhi, 110017, India

RECRUITING

All India Institute of Medical Sciences

New Delhi, New Delhi, 110029, India

RECRUITING

Sparsh Hospital & Critical care(P) LTD

Bhubaneswar, Odisha, 751007, India

RECRUITING

Jawaharlal Institute of postgraduate medical education and research

Puducherry, Puducherry, 605006, India

RECRUITING

Apollo Cancer Hospital

Hyderabad, Telangana, 500033, India

RECRUITING

Basavatarakam Indo American Cancer Hospital & Research Institute

Hyderabad, Telangana, 500034, India

RECRUITING

BP Poddar Hospital & Medical Research Ltd

Kolkata, West Bengal, 700053, India

RECRUITING

Tata Medical Center

Kolkata, West Bengal, 700160, India

RECRUITING

Chittaranjan National Cancer Institute

Kolkata, West Bengal, 9830115905, India

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Stomach Neoplasms; Colonic Neoplasms; Esophageal Neoplasms; Kidney Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Akhil Kumar

  Aurigene Oncology Limited

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suchit Kumbhare

CONTACT

+91 8104730078; suchit_k@aurigene.com

Suresh Oduru

CONTACT

+91 9866225593; suresh_o@aurigene.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose Escalation "3+3" Design

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 18, 2023
• Study Start: September 5, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (37)