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

NCT05984147 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: AUR108-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 27

Brief 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.

Conditions

Relapsed Advanced Lymphomas

Keywords

Relapse Advanced Lymphomas; Diffuse large B-cell lymphoma; Follicular lymphoma; Mature T/NK-cell lymphomas; Other Hodgkin lymphoma

Outcome Measures

Primary Outcomes (9)

• 1. First cycle Dose Limiting Toxicities (DLT)

  Assess dose limiliting toxicities of AUR108

  28 Days

• Safety of AUR108 as measured by the number of participants with treatment-related adverse events (AE) graded according to NCI CTCAE version 5.0

  Number of participants with TEAEs

  Through study completion, an average of 1 year

• Pharmacokinetics Maximum Concentration (Cmax)

  Maximum Concentration of AUR108

  Day 1 and Day 17

• Pharmacokinetics: Time to Maximum concentration (Tmax)

  Tmax in hours

  Day 1 and Day 17

• Pharmacokinetics: Area under the curve (AUC)

  Area under the curve (AUC) of AUR108 in h\* ng/mL

  Day 1 and Day 17

• Pharmacokinetics: Terminal elimination half-life

  Terminal elimination half-life of AUR 108 in hours

  Day 17

• Maximum concentration (Cmax) administered under fasting/fed condition

  Compare in fast and fed conditions

  Day 8

• Time to Maximum concentration (Tmax) administered under fasting/fed condition

  Compare Tmax in fast and fed conditions

  Day 8

• Area under curve (AUC) administered under fasting/fed condition

  Compare AUC in fast and fed conditions

  Day 8

Other Outcomes (4)

• PD biomarker assessment

  Day 1, Day 2, Day 17 and Day 18

• Overall Response Rate

  Through study completion, an average of 1 year

• Duration of Response

  Through study completion, an average of 1 year

Study Arms (1)

AUR108, 50mg to 300mg

EXPERIMENTAL

Currently, planned dose levels are 50,90,150,220,300 mg will be administered in 3+/4- regimen.

Drug: AUR108

Interventions

AUR108 DRUG

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

AUR108, 50mg to 300mg

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females ≥ 18 years of age
• Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1
• Acceptable bone marrow and organ function at screening as described below:
• ANC ≥ 1000/μL (without WBC growth factor support)
• Platelet count ≥ 75,000/μL without transfusion support
• Hemoglobin ≥ 9 g/dL (Transfusion is allowed to achieve this Hb)
• Total Bilirubin ≤ 1.5 x ULN; (Patients with known Gilbert's syndrome are allowed with a Total Bilirubin ≤ 2.5 x ULN)
• AST (SGOT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases)
• ALT (SGPT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases)
• 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 \[kg\] × \[0.85 if Female\] / \[72 × serum creatinine (mg/dL)\]).
• Ability to swallow and retain oral medications
• 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.
• 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.
• 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.
• Evidence of measurable disease as per Lugano Criteria for Lymphoma (Cheson BD et al, 2014).

You may not qualify if:

• 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.
• 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.
• 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.
• Patients with cutaneous lymphomas, mycosis fungoides (MF) or Sézary syndrome (SS).
• Primary CNS lymphoma
• 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
• Patients with lymphoma that requires immediate cytoreductive therapy
• Patients with lymphoma that requires immediate cytoreductive therapy
• Patients on the drugs which are sensitive substrates of CYP2C8 and cannot be discontinued at least one week prior to Cycle 1 Day 1
• 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
• Major surgery ≤ 28 days from Cycle 1 Day 1 (major surgery is defined as a procedure requiring general anesthesia)
• 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.
• Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome-related illness

Sponsors & Collaborators

• Aurigene Discovery Technologies Limited: lead

Study Sites (27)

Omega Cancer Hospitals

Visakhapatnam, Andhra Pradesh, 530040, India

RECRUITING

Post Graduate Institute of Medical Education & Research,

Chandigarh, Chandigarh, 160012, India

RECRUITING

Cellcure Care Cancer Pvt Ltd

Ahmedabad, Gujarat, 380009, India

RECRUITING

HCC Happiness Care and Cure Multispeciality Hospital

Ahmedabad, Gujarat, 380015, India

RECRUITING

Shankus Hospital Pvt. Ltd.

Ahmedabad, Gujarat, 384110, India

RECRUITING

Unique Hospital

Surat, Gujarat, 395002, India

RECRUITING

Kiran Multi Speciality Hospital

Surat, Gujarat, 395004, India

RECRUITING

Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences

Rohtak, Haryana, 124001, India

RECRUITING

Super Specialty Hospital (G.M.C) Srinagar

Srinagar, Jammu and Kashmir, 190010, India

RECRUITING

KLES Dr Prabhakar Kore Hospital and MRC

Belagavi, Karnataka, 590010, India

RECRUITING

Amrita Institute of Medical Sciences (AIMS)

Kochi, Kerala, 682041, India

RECRUITING

Sujan Surgical Cancer Hospital and Amravati Cancer Foundation

Amravati, Maharashtra, 444606, India

RECRUITING

Dr. Bafna's Star Superspeciality Clinic & Hospital

Kolhāpur, Maharashtra, 416005, India

RECRUITING

Kolhapur Cancer Centre

Kolhāpur, Maharashtra, 416234, India

RECRUITING

Mumbai Onco Care Centre

Mumbai, Maharashtra, 400056, India

RECRUITING

All India Institute of Medical Sciences

Nagpur, Maharashtra, 441108, India

RECRUITING

HCG Manavata Cancer Centre

Nashik, Maharashtra, 422002, India

RECRUITING

Deenanath Mangeshkar Hospital & Research Center

Pune, Maharashtra, 411004, India

RECRUITING

Sahyadri Super Specialty Hospital

Pune, Maharashtra, 411006, India

RECRUITING

Sushrut Hospital

Pune, Maharashtra, 411038, India

RECRUITING

Armed Forces Medical College

Pune, Maharashtra, 41140, India

RECRUITING

Sunact Cancer Institute Pvt. Ltd

Thane, Maharashtra, 400615, India

RECRUITING

Rajiv Gandhi Cancer Institute and Research Centre

Delhi, National Capital Territory of Delhi, 110085, India

RECRUITING

All India Institute of Medical Sciences

Delhi, New Delhi, 10029, India

RECRUITING

Sparsh Hospital and Critical Care (P) Ltd.

Bhubaneswar, Odisha, 751007, India

RECRUITING

MNJ Institute of Oncology & Regional Cancer Centre

Hyderabad, Telangana, 500004, India

RECRUITING

Tata Medical Center

Kolkata, West Bengal, 700160, India

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Lymphoma, T-Cell

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Akhil Kumar

  Chief Medical Officer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suchit Kumbhare

CONTACT

+918104730078; suchit_k@aurigene.com

Suresh Oduru

CONTACT

9866225593; suresh_o@aurigene.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequential Assignment Dose Escalation "3+3" Design

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 9, 2023
• Study Start: October 19, 2023
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (27)