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Recruiting Phase 1

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

NCT05984147 · tracked via the Priya Life Science India tracker
Phase
Phase 1
Started
2023-10-19
Last updated
2026-04-17

Condition(s) studied

Relapsed Advanced Lymphomas

Investigational drug(s) / intervention(s)

AUR108

AUR108: 3 Days dosing, and 4 days no dose in a week

Study summary

An open-label, first-in-human, Phase 1 study in adult patients with relapsed advanced lymphomas will be done to assess AUR108 safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose.

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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: 1. ANC ≥ 1000/μL (without WBC growth factor support) 2. Platelet count ≥ 75,000/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) ≥ 30 mL/min (either measured or estimated by the Cockcroft-Gault formula). (Cockcroft-Gault formula for estimated creatinine clearance \[eCrCl\]: eCrCl = \[140- Age\] × Weight \[kg\] × \[0.85 if Female\] / \[72 × serum creatinine (mg/dL)\]). 4. Ability to swallow and retain oral medications 5. Histo-pathological diagnosis of a Non-Hodgkin lymphoma orHodgkin Lymphoma. Note: The lymphoma should be either in Stage III or IV according to Lugano classification (Cheson BD et al, 2014) at screening. 6. In the case of subjects who have lymphoma for which high-dose chemotherapy and autologous stem cell transplantation (HDASCT) is considered a standard curative therapy, eligibility for this study requires that the subject's disease has relapsed after HDASCT, that the subject is not eligible for HD-ASCT, or that the subject has refused HD-ASCT. 7. In the case of subjects who have lymphoma for which CAR-T therapy is considered a standard therapy, eligibility for this study requires that the subjects disease has relapsed after CAR-T, or that the subject has refused CAR-T, or that the CAR-T therapy is not accessible to the patient. 8. Evidence of measurable disease as per Lugano Criteria for Lymphoma (Cheson BD et al, 2014). 9. Standard curative measures do not exist, and patient must have exhausted all effective therapies, available locally. 1. At a minimum, the patients must have received at least 2 prior lines of systemic therapies. These systemic therapies could be either in the stage II, III or IV. 2. 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, 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). 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) central nervous system (CNS) lymphoma. Patients with previously treated (\> 6 months of screening) CNS lymphoma and are now stable and asymptomatic, from CNS perspective, are allowed 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 be discontinued 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 one week prior to Cycle 1 Day 1 12. Major surgery ≤ 28 days from Cycle 1 Day 1 (major surgery is defined as a procedure requiring general anesthesia) 13. Active infection requiring systemic therapy. Note: Prophylactic use of antibiotics is allowed. Any infection detected during screening period which is resolved adequately according to investigator before the Cycle 1 Day 1, is allowed. 14. Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency 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 or targeted therapy while on study. 17. 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 18. Ongoing cardiac dysrhythmias requiring treatment of any grade or treatment of cardiac dysrhythmias 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, 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 21. 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 person(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 cancer of the cervix in situ and the disease under study. 23. Positive pregnancy test for women of child-bearing potential (WOCBP) at the screening or enrolment visit 24. Lactating women or WOCBP who are neither surgically sterilized nor willing to use reliable contraceptive methods (hormonal contraceptive, IUD, or any double combination of male or female condom, spermicidal gel, diaphragm, sponge, cervical cap).

Primary outcome measure(s)

  • 1. First cycle Dose Limiting Toxicities (DLT) — 28 Days
    Assess dose limiliting toxicities of AUR108
  • Safety of AUR108 as measured by the number of participants with treatment-related adverse events (AE) graded according to NCI CTCAE version 5.0 — Through study completion, an average of 1 year
    Number of participants with TEAEs
  • Pharmacokinetics Maximum Concentration (Cmax) — Day 1 and Day 17
    Maximum Concentration of AUR108
  • Pharmacokinetics: Time to Maximum concentration (Tmax) — Day 1 and Day 17
    Tmax in hours
  • Pharmacokinetics: Area under the curve (AUC) — Day 1 and Day 17
    Area under the curve (AUC) of AUR108 in h\* ng/mL
  • Pharmacokinetics: Terminal elimination half-life — Day 17
    Terminal elimination half-life of AUR 108 in hours
  • Maximum concentration (Cmax) administered under fasting/fed condition — Day 8
    Compare in fast and fed conditions
  • Time to Maximum concentration (Tmax) administered under fasting/fed condition — Day 8
    Compare Tmax in fast and fed conditions
  • Area under curve (AUC) administered under fasting/fed condition — Day 8
    Compare AUC in fast and fed conditions

Trial sites (27)

FacilityCityRegionStatus
Omega Cancer Hospitals Visakhapatnam Andhra Pradesh Recruiting
Post Graduate Institute of Medical Education & Research, Chandigarh Chandigarh Recruiting
Cellcure Care Cancer Pvt Ltd Ahmedabad Gujarat Recruiting
HCC Happiness Care and Cure Multispeciality Hospital Ahmedabad Gujarat Recruiting
Shankus Hospital Pvt. Ltd. Ahmedabad Gujarat Recruiting
Unique Hospital Surat Gujarat Recruiting
Kiran Multi Speciality Hospital Surat Gujarat Recruiting
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences Rohtak Haryana Recruiting
Super Specialty Hospital (G.M.C) Srinagar Srinagar Jammu and Kashmir Recruiting
KLES Dr Prabhakar Kore Hospital and MRC Belagavi Karnataka Recruiting
Amrita Institute of Medical Sciences (AIMS) Kochi Kerala Recruiting
Sujan Surgical Cancer Hospital and Amravati Cancer Foundation Amravati Maharashtra Recruiting
Dr. Bafna's Star Superspeciality Clinic & Hospital Kolhāpur Maharashtra Recruiting
Kolhapur Cancer Centre Kolhāpur Maharashtra Recruiting
Mumbai Onco Care Centre Mumbai Maharashtra Recruiting
All India Institute of Medical Sciences Nagpur Maharashtra Recruiting
HCG Manavata Cancer Centre Nashik Maharashtra Recruiting
Deenanath Mangeshkar Hospital & Research Center Pune Maharashtra Recruiting
Sahyadri Super Specialty Hospital Pune Maharashtra Recruiting
Sushrut Hospital Pune Maharashtra Recruiting
Armed Forces Medical College Pune Maharashtra Recruiting
Sunact Cancer Institute Pvt. Ltd Thane Maharashtra Recruiting
Rajiv Gandhi Cancer Institute and Research Centre Delhi National Capital Territory of Delhi Recruiting
All India Institute of Medical Sciences Delhi New Delhi Recruiting
Sparsh Hospital and Critical Care (P) Ltd. Bhubaneswar Odisha Recruiting
MNJ Institute of Oncology & Regional Cancer Centre Hyderabad Telangana Recruiting
Tata Medical Center Kolkata West Bengal Recruiting
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 NCT05984147 on ClinicalTrials.gov ↗ ← All trials in India