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

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:
4. ANC ≥ 1500/μL (without WBC growth factor support)
5. Platelet count ≥ 100,000/μL without transfusion support
6. Hemoglobin ≥ 9 g/dL (Transfusion is allowed to achieve this Hb)
7. Total Bilirubin ≤ 1.5 x ULN; (Patients with known Gilbert's syndrome are allowedwith a Total Bilirubin ≤ 2.5 x ULN)
8. AST (SGOT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases)
9. ALT (SGPT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases)
10. Creatinine clearance (CrCl) ≥ 60 mL/min (either measured or estimated by theCockcroft-Gault formula).
11. Ability to swallow and retain oral medications.
12. Histopathological diagnosis of a solid tumor. Note: The solid tumors must be in StageIV at screening.
13. Evidence of measurable disease per RECIST, v1.1 for solid tumors.
14. Standard curative measures do not exist, and the patient must have exhausted alleffective therapies available locally. Notes: 7a. At a minimum, solid tumor patients must have received at least two lines of systemictherapies in the metastatic incurable settings (these two lines must be in the metastaticsetting 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, orimmunomodulatory 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 medroxyprogesteroneis allowed. Note: Patients with CRPC (castrate-resistant prostate cancer) should continue toreceive ongoing medical castration with LHRH analogs, and such patients are allowed.
2. Presence of acute or chronic toxicity resulting from prior anticancer treatment, withthe exception of alopecia or nail changes, that has not resolved to Grade ≤ 1, asdetermined by NCI CTCAE v 5.0.
3. Definitive Radiotherapy within the last 21 days of Cycle 1 Day 1 (limited fieldpalliative radiation is allowed and no restrictions during the screening period orduring the trial) • Use of any investigational agent within 28 days or 5 half-lives (whichever islonger) prior to Cycle 1 Day 1.
4. Use of drugs which are moderate / strong CYP3A4 inducers and/or drugs which arepredominantly 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 mustbe either avoided or used with caution beyond DLT evaluation period.
5. Known symptomatic or untreated or recently treated (≤ 6 months of screening) centralnervous system (CNS) metastases. Patients with previously treated (> 6 months ofscreening) 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 procedurerequiring general anesthesia).
7. Patients with leukemia, myelodysplastic syndrome, multiple myeloma, or lymphoma.
8. Active infection requiring systemic therapy. Note: Prophylactic use of antibiotics isallowed. Any infection detected during the screening period which is resolvedadequately according to investigator before the Cycle 1 Day 1, is allowed.
9. Known to be human immunodeficiency virus (HIV) positive or have an acquiredimmunodeficiency 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 ortargeted therapy while on study.
12. Uncontrolled congestive heart failure (New York Heart Association [NYHA] Class 2-4),angina, myocardial infarction, cerebrovascular accident, coronary/peripheral arterybypass graft surgery, or transient ischemic attack, or pulmonary embolism within 3months prior to Cycle 1 Day 1.
13. Ongoing cardiac dysrhythmias requiring treatment of any grade or treatment of cardiacdysrhythmias 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, symptomaticcongestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiacarrhythmia, active peptic ulcer disease or significant gastritis, active bleedingdiatheses, presence of any major medical illness (e.g., renal, hepatic, hematologic,gastrointestinal, endocrine, pulmonary, or psychiatric illness/social situations orclinically significant laboratory / ECG abnormalities at screening, any or acombination of illnesses, which, in the opinion of the PI, may either put the patientat risk because of participation in the study or influence the results or thepatient's ability to participate in the study.
16. Current swab-positive or suspected (under investigation) Covid-19 infection or feverand other signs or symptoms suggestive of Covid-19 infection with recent contact ofthe 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 screeningor enrolment visit.
18. Lactating women or WOCBP who are neither surgically sterilized nor willing to usereliable contraceptive methods. (hormonal contraceptive, IUD, or any doublecombination of the male or female condom, spermicidal gel, diaphragm, sponge, cervicalcap).