Study Evaluating Safety Pharmacokinetics and Pharmacodynamics of AUR112 in Patients With Relapsed Advanced Lymphoma

NCT06755450 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: AUR112-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 19

Brief Summary

A Phase 1, Open Label, Dose Escalation, Multicenter, First-in-Human (FIH) Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of Oral AUR112 in Patients with Relapsed Advanced Lymphoma (ADITI-1)

Conditions

Relapsed Advanced Lymphomas

Keywords

Non-Hodgkin Lymphoma (NHL); Hodgkin Lymphoma; Relapse Advanced Lymphomas

Outcome Measures

Primary Outcomes (11)

• First cycle Dose Limiting Toxicities (DLT).

  Number of participants with dose limiting toxicities (DLT) taking AUR112

  28 days (Cycle 1)

• Safety of AUR112 as measured by the number of participants with treatment related adverse events (AE) graded according to NCI CTCAE version 5.0

  The assessment of safety was based on the frequency of deaths, adverse event (AE), serious adverse event (SAE)s leading to discontinuation of study drug, and abnormalities in specific laboratory assessments. AEs and laboratory values will be graded for severity according to NCI CTCAE version 5.0

  28 days

• To determine the doses to be recommended for evaluation in future studies.

  Determine selected dose(s) to be studied in future clinical trials

  28 days

• Pharmacokinetics: Maximum concentration (Cmax)

  Maximum concentration of AUR112

  [Time Frame: Day 1 and Day 15]

• Pharmacokinetics: Time to Maximum concentration (Tmax)

  Tmax in hours

  [Time Frame: Day 1 and Day 15]

• Pharmacokinetics: Area under the curve (AUC)

  Area under the curve (AUC) of AUR 112 in h\* mcg/mL

  [Time Frame: Day 1 and Day 15]

• Pharmacokinetics: Mean Residence Time (MRT)

  Average time the drugs stays in the body

  [Time Frame: Day 1 and Day 15]

• Pharmacokinetics: Terminal elimination half-life

  Terminal elimination half-life of AUR 112 in hours

  [Time Frame: Day 1 and Day 15]

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

  Compare in fast and fed conditions

  [Time Frame: Day 8 and Day 9]

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

  Compare Tmax in fast and fed conditions

  [Time Frame: Day 8 and Day 9]

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

  Compare AUC in fast and fed conditions

  [Time Frame: Day 8 and Day 9]

Other Outcomes (5)

• Exploratory endpoint: Expression of cytokines

  [Time Frame: Day 1, Day 2, and Day 15]

• Exploratory endpoint: Gene expression profile

  [Time Frame: Day 1, Day 2, and Day 15]

• Exploratory endpoint- Efficacy assessments, Overall Response Rate

  [Time Frame: Through study completion, an average of 1 year]

Study Arms (1)

AUR112

EXPERIMENTAL

Experimental: AUR112, 100mg to 1200mg Currently, six (6) planned dose levels are 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, and 1200 mg once daily (QD). AUR112: Once daily

Drug: AUR112

Interventions

AUR112 DRUG

Once daily

AUR112

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 and 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: For patients with CLL ≥ 50,000/μL; For patients with lymphomas ≥ 75,000/μL without bone marrow involvement and ≥ 50,000/μL with bone marrow involvement. These thresholds should be qualified without platelet transfusion support.
• Hemoglobin ≥ 9 g/dL (RBC 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) ≥ 60 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
• Histopathological diagnosis of Non-Hodgkin Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL) or Hodgkin disease. Note:
• Mature B-cell neoplasms (excluding plasma cell neoplasms, heavy chain disease, and primary central nervous system \[CNS\] lymphoma).
• Mature T- and NK-cell neoplasms.
• Hodgkin lymphomas 5c. The CLL should be Binet Stage C/Rai stage III or IV, as per the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines (Hallek et al. 2018).

You may not qualify if:

• 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 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. 1
• 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 Burkitt's lymphoma, Burkitt-like lymphoma, posttransplant lymphoproliferative disease, primary mediastinal large-B cell lymphoma, cutaneous lymphomas, mycosis fungoides (MF), or Sezary syndrome (SS).
• 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 low-grade lymphoma or indolent lymphoma that does not meet conventional criteria (Jeong SH, 2022) for requiring treatment.
• Patients on drugs which are inhibitors of P-gp or BCRP or UGT1A1 and when these drugs cannot be discontinued from at least one week prior to Cycle 1 Day 1. Note: These drugs will be prohibited during Cycle 1 of therapy.
• 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.
• Known active or chronic hepatitis B (HBsAg +ve) or hepatitis C infection (HCV antibody +ve).
• The patient who is expected to require any other form of antineoplastic therapy or targeted therapy while on study
• 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.

Sponsors & Collaborators

• Aurigene Discovery Technologies Limited: lead

Study Sites (19)

Sir Sayajirao General Hospital (SSG)

Vadodara, Gujarat, 390001, India

ACTIVE NOT RECRUITING

National Cancer Institute , All India Institute of Medical Sciences

Jhajjar, Haryana, 124105, India

RECRUITING

Health Care Global Enterprises

Bangalore, Karnataka, 560027, India

ACTIVE NOT RECRUITING

Srinivasam Cancer Care Multi Speciality Hospitals India Pvt Ltd. , Bangalore 560072.

Bangalore, Karnataka, 560027, India

RECRUITING

Jeevan Amrut Hematology Center, Aurangabad

Aurangabad, Maharashtra, 431001, India

RECRUITING

HCG Cancer Centre

Nagpur, Maharashtra, 440026, India

RECRUITING

Sahyadri Hospital Private Limited

Pune, Maharashtra, 410014, India

RECRUITING

Novo Solitaire Care

Pune, Maharashtra, 411014, India

RECRUITING

Armed Forces Medical College

Pune, Maharashtra, 411040, India

NOT YET RECRUITING

Onco Life Cancer, Centre, Satara

Satara, Maharashtra, 415519, India

RECRUITING

Sunact Cancer Institute Pvt. Ltd

Thane, Maharashtra, 400 615, India

RECRUITING

Siddharth Gupta Memorial Hospital,

Wardha, Maharashtra, 442107, India

RECRUITING

Tata Memorial Hospital

Pārel, Mumbai, 400012, India

RECRUITING

AIIMS, New Delhi

New Delhi, New Delhi, 110029, India

ACTIVE NOT RECRUITING

Max Super Specialty Hospital

Saket, New Delhi, 110017, India

ACTIVE NOT RECRUITING

AIIMS, Bhubaneswar

Bhubaneswar, Odisha, 751019, India

RECRUITING

Somani Hospital

Jaipur, Rajasthan, 302019, India

ACTIVE NOT RECRUITING

AIIMS, Rishikesh

Rishikesh, Uttarakhand, 249203, India

RECRUITING

Tata Medical Centre

Kolkata, West Bengal, 700160, India

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Hodgkin Disease

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Akhil Kumar

  Aurigene Oncology Limited

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suchit D Kumbhare

CONTACT

+91- 8104730078; suchit_k@aurigene.com

Suresh O

CONTACT

+91-9866225593; 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 Design

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 1, 2025
• Study Start: January 15, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 15, 2028
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (19)