RecruitingPhase 1NCT05865002

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

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)

Sponsor

Aurigene Discovery Technologies Limited

Enrollment

50 participants

Start Date

Sep 5, 2023

Study Type

INTERVENTIONAL

Conditions

Relapsed Malignant Solid Neoplasm

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (SHAKTI-1) tests AUR107, a new oral drug, in people with advanced solid tumors (stage IV) that have come back or stopped responding to all available treatments. **You may be eligible if...** - You are 18 years or older - You have a confirmed stage IV solid tumor - Your cancer has progressed after at least two lines of standard treatment for metastatic disease - There is no other available treatment option that is likely to help - You are in good general health (ECOG 0 or 1) with adequate organ function - You are able to swallow pills **You may NOT be eligible if...** - You have recently received other anti-cancer therapy (chemotherapy, immunotherapy, etc.) - There is still an effective treatment available that you have not yet tried - You have serious infections, active brain metastases, or significant organ dysfunction - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAUR107

Once daily

Locations(37)

HCG City Cancer Centre

Vijayawada, Andhra Pradesh, India

Omega Hospital

Visakhapatnam, Andhra Pradesh, India

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

Chandigarh, Chandigarh, India

Apollo Hospital International Limited

Ahmedabad, Gujarat, India

Universal Superspeciality Hospital

Surat, Gujarat, India

Unique Hospital Multispeciality and Research Institute

Surat, Gujarat, India

Kiran Hospital Multi Super Speciality Hospital & Research Centre

Surat, Gujarat, India

Pt.B.D Sharma PGIMS Rohtak

Rohtak, Haryana, India

Sri Shankara Cancer Hospital and Research Centre

Bangalore, Karnataka, India

Healthcare Global Enterprises Ltd

Bangalore, Karnataka, India

Cytecare Hospitals Pvt. Ltd

Bangalore, Karnataka, India

Vydehi Institute of Medical Sciences and Research Centre

Bangalore, Karnataka, India

KLEs Dr. Prabhakar Kore Hospital & Medical Research Center

Bangalore, Karnataka, India

K R Hospital

Mysore, Karnataka, India

Krupamayi Hospital

Aurangabad, Maharashtra, India

Kolhapur Cancer Centre

Kolhāpur, Maharashtra, India

Kims-Kingsway Hospitals

Nagpur, Maharashtra, India

Rhythm Heart And Critical Care

Nagpur, Maharashtra, India

Treat Me Hospital

Nagpur, Maharashtra, India

Soham Hospital

Nashik, Maharashtra, India

HCG Manavata Cancer Centre

Nashik, Maharashtra, India

Cancure Day Care Centre

Navi Mumbai, Maharashtra, India

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

Navi Mumbai, Maharashtra, India

Grant Medical Foundation Ruby Hall Clinic

Pune, Maharashtra, India

MMFHA Joshi Hospital

Pune, Maharashtra, India

Novo Solitaire Care

Pune, Maharashtra, India

Onco-Life Cancer Centre

Pune, Maharashtra, India

Sunact Cancer Institute Pvt Ltd

Thane, Maharashtra, India

Max Super Speciality Hospital

New Delhi, New Delhi, India

All India Institute of Medical Sciences

New Delhi, New Delhi, India

Sparsh Hospital & Critical care(P) LTD

Bhubaneswar, Odisha, India

Jawaharlal Institute of postgraduate medical education and research

Puducherry, Puducherry, India

Apollo Cancer Hospital

Hyderabad, Telangana, India

Basavatarakam Indo American Cancer Hospital & Research Institute

Hyderabad, Telangana, India

BP Poddar Hospital & Medical Research Ltd

Kolkata, West Bengal, India

Tata Medical Center

Kolkata, West Bengal, India

Chittaranjan National Cancer Institute

Kolkata, West Bengal, India

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05865002