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A Study Evaluating the Safety and Efficacy of AUR107 in Patients With Relapsed Advanced Malignancies (SHAKTI-1)
Study Purpose
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.
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
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).Trial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
Arms
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
Interventions
Drug: - AUR107
Once daily
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
International Sites
Status
Not yet recruiting
Address
HCG City Cancer Centre
Vijayawada, Andhra Pradesh, 520002
Site Contact
Dr Lakshmi Priyadarshini
[email protected]
+91 9966030988
Status
Recruiting
Address
Omega Hospital
Visakhapatnam, Andhra Pradesh, 530040
Site Contact
Dr. Bellala Ravishankar
[email protected]
+91 9849123256
Status
Recruiting
Address
Unique Hospital Multispeciality and Research Institute
Surat, Gujarat, 395002
Site Contact
Dr. Ankit Patel
[email protected]
+91 9825404202
Status
Recruiting
Address
Vydehi Institute of Medical Sciences and Research Centre
Bangalore, Karnataka, 560066
Site Contact
Shashidhar V Karpurmath, MBBS
[email protected]
8861085629
Status
Recruiting
Address
K R Hospital
Mysore, Karnataka, 570001
Site Contact
Dr. Mukesh S
[email protected]
+91 9886873788
Status
Recruiting
Address
Grant Medical Foundation Ruby Hall Clinic
Pune, Maharashtra, 411001
Site Contact
Dr. Minish Jain
[email protected]
+91 9823133390
Status
Recruiting
Address
Krupamayi Hospital
Aurangabad, Maharastra, 431001
Site Contact
Dr Viraj Vijay Borgaonkar
[email protected]
+91 9673073555
Status
Recruiting
Address
All India Institute of Medical Sciences
New Delhi, , 110029
Site Contact
Dr. Deepam Pushpam
[email protected]
+91 9650629370
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