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

Launched by AURIGENE DISCOVERY TECHNOLOGIES LIMITED · May 9, 2023

Keywords

ClinConnect Summary

The SHAKTI-1 clinical trial is studying a new medication called AUR107 to see if it is safe and effective for adults with relapsed advanced cancers, specifically solid tumors that have come back after previous treatments. This is a Phase 1 study, which means it is one of the first times this medication is being tested in humans. The trial is currently recruiting participants aged 18 and older who have advanced solid tumors and have already tried at least two different types of systemic therapies without success. Participants must also have acceptable health and organ function, as determined by specific blood tests and overall health assessments.

If you join this study, you will take AUR107 and be closely monitored by doctors to assess how well you tolerate the medication and any side effects you may experience. The goal is to find the right dose that is both effective and safe. Participants should also know that certain health conditions or recent treatments may prevent them from joining the study, like having active infections or undergoing major surgery recently. This trial represents a hopeful opportunity for patients who have limited treatment options left.

Gender

ALL

Eligibility criteria

• 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).