RecruitingPhase 1NCT06755450

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

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)

Sponsor

Aurigene Discovery Technologies Limited

Enrollment

40 participants

Start Date

Jan 15, 2025

Study Type

INTERVENTIONAL

Conditions

Relapsed Advanced Lymphomas

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)

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new investigational drug in patients with non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), or Hodgkin disease — blood cancers — to evaluate its safety, how the body processes it, and how it affects the cancer. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of NHL, CLL, or Hodgkin disease - Your lymphoma is at an advanced stage (stage III or IV) or your CLL requires treatment - You are in good health (ECOG 0–1) and can swallow pills - Your blood counts and organ function are within required ranges **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have active, uncontrolled infections - Your platelet count, kidney, or liver function falls below acceptable thresholds - You have had certain prior treatments that disqualify participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAUR112

Once daily

Locations(19)

Sir Sayajirao General Hospital (SSG)

Vadodara, Gujarat, India

National Cancer Institute , All India Institute of Medical Sciences

Jhajjar, Haryana, India

Health Care Global Enterprises

Bangalore, Karnataka, India

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

Bangalore, Karnataka, India

Jeevan Amrut Hematology Center, Aurangabad

Aurangabad, Maharashtra, India

HCG Cancer Centre

Nagpur, Maharashtra, India

Sahyadri Hospital Private Limited

Pune, Maharashtra, India

Novo Solitaire Care

Pune, Maharashtra, India

Armed Forces Medical College

Pune, Maharashtra, India

Onco Life Cancer, Centre, Satara

Satara, Maharashtra, India

Sunact Cancer Institute Pvt. Ltd

Thane, Maharashtra, India

Siddharth Gupta Memorial Hospital,

Wardha, Maharashtra, India

Tata Memorial Hospital

Parel, Mumbai, India

AIIMS, New Delhi

New Delhi, New Delhi, India

Max Super Specialty Hospital

Sāket, New Delhi, India

AIIMS, Bhubaneswar

Bhubaneswar, Odisha, India

Somani Hospital

Jaipur, Rajasthan, India

AIIMS, Rishikesh

Rishikesh, Uttarakhand, India

Tata Medical Centre

Kolkata, West Bengal, India

View Full Details on ClinicalTrials.gov

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NCT06755450

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