Actively Recruiting
Study Evaluating Safety Pharmacokinetics and Pharmacodynamics of AUR112 in Patients With Relapsed Advanced Lymphoma
Led by Aurigene Discovery Technologies Limited · Updated on 2026-01-13
40
Participants Needed
19
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study Evaluating Safety Pharmacokinetics and Pharmacodynamics of AUR112 in Patients With Relapsed Advanced Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- ECOG performance status of 0 or 1
- Acceptable bone marrow and organ function including ANC ≥ 1000/µL, platelet counts as specified, hemoglobin ≥ 9 g/dL, bilirubin ≤ 1.5 x ULN (or ≤ 2.5 x ULN if Gilbert's syndrome), AST and ALT ≤ 3 x ULN (or ≤ 5 x ULN with liver metastases), and creatinine clearance ≥ 60 mL/min
- Ability to swallow and retain oral medications
- Histopathological diagnosis of Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, or Hodgkin disease in advanced stages
- Lymphoma stage III or IV per Lugano classification or CLL at Binet Stage C/Rai stage III or IV
- Relapsed disease after high-dose chemotherapy and autologous stem cell transplantation or ineligible/refused transplant
- Relapsed disease after CAR-T therapy or ineligible/refused CAR-T or CAR-T not available locally
- Evidence of measurable disease as per criteria
- Relapsed or refractory to at least 2 prior systemic therapies and exhausted effective local treatments
- Patients with progressive or symptomatic disease requiring treatment as per guidelines
You will not qualify if you...
- Anti-cancer therapy within 28 days or 5 half-lives before study start, except low dose prednisone up to 10 mg/day
- Unresolved toxicities from prior treatments above Grade 1 except alopecia or nail changes
- Radiotherapy within 21 days before study start, except limited palliative radiation
- Use of investigational agents within 28 days or 5 half-lives before study
- Diagnosis of Burkitt's lymphoma, Burkitt-like lymphoma, posttransplant lymphoproliferative disease, primary mediastinal large-B cell lymphoma, cutaneous lymphomas, mycosis fungoides, or Sezary syndrome
- Known symptomatic or untreated CNS lymphoma within 6 months
- Lymphoma requiring immediate cytoreductive therapy
- Low-grade or indolent lymphoma not meeting treatment criteria
- Use of certain drugs inhibiting P-gp, BCRP, or UGT1A1 that cannot be stopped before study
- Major surgery within 28 days before study
- Active infection requiring systemic therapy at study start
- HIV positive or AIDS-related illness
- Active or chronic hepatitis B or C infection
- Expected to need other antineoplastic or targeted therapy during study
- Uncontrolled serious cardiovascular or medical conditions
- Current suspected or confirmed COVID-19 infection
- History of another primary cancer within 5 years except certain skin or cervical cancers
- Positive pregnancy test or not using reliable contraception if of child-bearing potential or partner to such an individual
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Sir Sayajirao General Hospital (SSG)
Vadodara, Gujarat, India, 390001
Active, Not Recruiting
2
National Cancer Institute , All India Institute of Medical Sciences
Jhajjar, Haryana, India, 124105
Actively Recruiting
3
Health Care Global Enterprises
Bangalore, Karnataka, India, 560027
Active, Not Recruiting
4
Srinivasam Cancer Care Multi Speciality Hospitals India Pvt Ltd. , Bangalore 560072.
Bangalore, Karnataka, India, 560027
Actively Recruiting
5
Jeevan Amrut Hematology Center, Aurangabad
Aurangabad, Maharashtra, India, 431001
Actively Recruiting
6
HCG Cancer Centre
Nagpur, Maharashtra, India, 440026
Actively Recruiting
7
Sahyadri Hospital Private Limited
Pune, Maharashtra, India, 410014
Actively Recruiting
8
Novo Solitaire Care
Pune, Maharashtra, India, 411014
Actively Recruiting
9
Armed Forces Medical College
Pune, Maharashtra, India, 411040
Not Yet Recruiting
10
Onco Life Cancer, Centre, Satara
Satara, Maharashtra, India, 415519
Actively Recruiting
11
Sunact Cancer Institute Pvt. Ltd
Thane, Maharashtra, India, 400 615
Actively Recruiting
12
Siddharth Gupta Memorial Hospital,
Wardha, Maharashtra, India, 442107
Actively Recruiting
13
Tata Memorial Hospital
Parel, Mumbai, India, 400012
Actively Recruiting
14
AIIMS, New Delhi
New Delhi, New Delhi, India, 110029
Active, Not Recruiting
15
Max Super Specialty Hospital
Sāket, New Delhi, India, 110017
Active, Not Recruiting
16
AIIMS, Bhubaneswar
Bhubaneswar, Odisha, India, 751019
Actively Recruiting
17
Somani Hospital
Jaipur, Rajasthan, India, 302019
Active, Not Recruiting
18
AIIMS, Rishikesh
Rishikesh, Uttarakhand, India, 249203
Actively Recruiting
19
Tata Medical Centre
Kolkata, West Bengal, India, 700160
Active, Not Recruiting
Research Team
S
Suchit D Kumbhare
CONTACT
S
Suresh O
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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