A Study Evaluating the Safety and Efficacy of AUR108 in Patients With Relapsed Advanced Lymphomas (ASHA-1)

Inclusion Criteria:

1. Males or 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 ≥ 1000/μL (without WBC growth factor support)
5. Platelet count ≥ 75,000/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) ≥ 30 mL/min (either measured or estimated by theCockcroft-Gault formula). (Cockcroft-Gault formula for estimated creatinineclearance [eCrCl]: eCrCl = [140- Age] × Weight [kg] × [0.85 if Female] / [72 ×serum creatinine (mg/dL)]).
11. Ability to swallow and retain oral medications
12. Histo-pathological diagnosis of a Non-Hodgkin lymphoma orHodgkin Lymphoma. Note: Thelymphoma should be either in Stage III or IV according to Lugano classification (Cheson BD et al, 2014) at screening.
13. In the case of subjects who have lymphoma for which high-dose chemotherapy andautologous stem cell transplantation (HDASCT) is considered a standard curativetherapy, eligibility for this study requires that the subject's disease has relapsedafter HDASCT, that the subject is not eligible for HD-ASCT, or that the subject hasrefused HD-ASCT.
14. In the case of subjects who have lymphoma for which CAR-T therapy is considered astandard therapy, eligibility for this study requires that the subjects disease hasrelapsed after CAR-T, or that the subject has refused CAR-T, or that the CAR-T therapyis not accessible to the patient.
15. Evidence of measurable disease as per Lugano Criteria for Lymphoma (Cheson BD et al, 2014).
16. Standard curative measures do not exist, and patient must have exhausted all effectivetherapies, available locally.
17. At a minimum, the patients must have received at least 2 prior lines of systemictherapies. These systemic therapies could be either in the stage II, III or IV.
18. Any cancer patient with access to any effective therapy must not be enrolled.

Exclusion Criteria:

1. Systemic anti-cancer therapy, such as chemotherapy, or biological therapy,immunomodulatory drug therapy, received within the past 28 days or 5 half-lives,whichever is longer, from the Cycle 1 Day 1 of the study. Note: Concomitant use of low dose prednisone (up to 10 mg/day) is allowed.
2. Presence of an acute or chronic toxicity resulting from prior anticancer treatment,with the 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).
4. Use of any investigational agent within 28 days or 5 half-lives (whichever is longer)prior to Cycle 1 Day 1.
5. Patients with cutaneous lymphomas, mycosis fungoides (MF) or Sézary syndrome (SS).
6. Primary CNS lymphoma
7. Known symptomatic or untreated or recently treated (≤ 6 months of screening) centralnervous system (CNS) lymphoma. Patients with previously treated (> 6 months ofscreening) CNS lymphoma and are now stable and asymptomatic, from CNS perspective, areallowed
8. Patients with lymphoma that requires immediate cytoreductive therapy
9. Patients with lymphoma that requires immediate cytoreductive therapy
10. Patients on the drugs which are sensitive substrates of CYP2C8 and cannot bediscontinued at least one week prior to Cycle 1 Day 1
11. Patients on the drugs which are sensitive substrates of either Poglycoprotein (P-gp)or breast cancer resistance protein (BCRP) and cannot be discontinued at least oneweek prior to Cycle 1 Day 1
12. Major surgery ≤ 28 days from Cycle 1 Day 1 (major surgery is defined as a procedurerequiring general anesthesia)
13. Active infection requiring systemic therapy. Note: Prophylactic use of antibiotics isallowed. Any infection detected during screening period which is resolved adequatelyaccording to investigator before the Cycle 1 Day 1, is allowed.
14. Known to be human immunodeficiency virus (HIV) positive or have an acquiredimmunodeficiency syndrome-related illness
15. Known active or chronic hepatitis B (HbsAg +ve) or hepatitis C infection (HCV antibody +ve)
16. The patient who is expected to require any other form of antineoplastic therapy ortargeted therapy while on study.
17. 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
18. Ongoing cardiac dysrhythmias requiring treatment of any grade or treatment of cardiacdysrhythmias in past 3 months, before Cycle 1 Day 1.
19. QTc (Bazzett) interval >460 ms on ECG at screening and/or at Cycle 1 Day 1 pre-dose.
20. 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
21. Current swab-positive or suspected (under investigation) Covid-19 infection or feverand other signs or symptoms suggestive of Covid-19 infection with recent contact ofperson(s) with confirmed Covid-19 infection, at screening or Cycle 1 Day 1.
22. History of another primary malignancy within 5 years prior to starting study drug,except for adequately treated basal or squamous cell carcinoma of the skin or cancerof the cervix in situ and the disease under study.
23. Positive pregnancy test for women of child-bearing potential (WOCBP) at the screeningor enrolment visit
24. Lactating women or WOCBP who are neither surgically sterilized nor willing to usereliable contraceptive methods (hormonal contraceptive, IUD, or any double combinationof male or female condom, spermicidal gel, diaphragm, sponge, cervical cap).