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Clinical Trials in India / NCT05865002
Recruiting Phase 1

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

NCT05865002 · tracked via the Priya Life Science India tracker
Sponsor
Aurigene Discovery Technologies Limited
Phase
Phase 1
Started
2023-09-05
Last updated
2026-04-17

Condition(s) studied

Relapsed Malignant Solid Neoplasm

Investigational drug(s) / intervention(s)

AUR107

AUR107: Once daily

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (37)

FacilityCityRegionStatus
HCG City Cancer Centre Vijayawada Andhra Pradesh Not Yet Recruiting
Omega Hospital Visakhapatnam Andhra Pradesh Recruiting
Post-Graduate Institute of Medical Education and Research(PGIMER) Chandigarh Chandigarh Recruiting
Apollo Hospital International Limited Ahmedabad Gujarat Recruiting
Universal Superspeciality Hospital Surat Gujarat Recruiting
Unique Hospital Multispeciality and Research Institute Surat Gujarat Recruiting
Kiran Hospital Multi Super Speciality Hospital & Research Centre Surat Gujarat Recruiting
Pt.B.D Sharma PGIMS Rohtak Rohtak Haryana Recruiting
Sri Shankara Cancer Hospital and Research Centre Bangalore Karnataka Active Not Recruiting
Healthcare Global Enterprises Ltd Bangalore Karnataka Recruiting
Cytecare Hospitals Pvt. Ltd Bangalore Karnataka Recruiting
Vydehi Institute of Medical Sciences and Research Centre Bangalore Karnataka Recruiting
KLEs Dr. Prabhakar Kore Hospital & Medical Research Center Bangalore Karnataka Recruiting
K R Hospital Mysore Karnataka Recruiting
Krupamayi Hospital Aurangabad Maharashtra Recruiting
Kolhapur Cancer Centre Kolhāpur Maharashtra Recruiting
Kims-Kingsway Hospitals Nagpur Maharashtra Recruiting
Rhythm Heart And Critical Care Nagpur Maharashtra Recruiting
Treat Me Hospital Nagpur Maharashtra Recruiting
Soham Hospital Nashik Maharashtra Recruiting
HCG Manavata Cancer Centre Nashik Maharashtra Recruiting
Cancure Day Care Centre Navi Mumbai Maharashtra Recruiting
The Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) Navi Mumbai Maharashtra Recruiting
Grant Medical Foundation Ruby Hall Clinic Pune Maharashtra Recruiting
MMFHA Joshi Hospital Pune Maharashtra Active Not Recruiting
Novo Solitaire Care Pune Maharashtra Recruiting
Onco-Life Cancer Centre Pune Maharashtra Recruiting
Sunact Cancer Institute Pvt Ltd Thane Maharashtra Recruiting
Max Super Speciality Hospital New Delhi New Delhi Recruiting
All India Institute of Medical Sciences New Delhi New Delhi Recruiting
Sparsh Hospital & Critical care(P) LTD Bhubaneswar Odisha Recruiting
Jawaharlal Institute of postgraduate medical education and research Puducherry Puducherry Recruiting
Apollo Cancer Hospital Hyderabad Telangana Recruiting
Basavatarakam Indo American Cancer Hospital & Research Institute Hyderabad Telangana Recruiting
BP Poddar Hospital & Medical Research Ltd Kolkata West Bengal Recruiting
Tata Medical Center Kolkata West Bengal Recruiting
Chittaranjan National Cancer Institute Kolkata West Bengal Recruiting

More Aurigene Discovery Technologies Limited trials in India

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05865002 on ClinicalTrials.gov ↗ ← All trials in India