RecruitingPhase 1NCT05984147

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

A Phase 1, Open Label, Dose Escalation, Dose Expansion, Multicenter Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of Oral AUR108 in Patients With Relapsed Advanced Lymphomas(ASHA-1)

Sponsor

Aurigene Discovery Technologies Limited

Enrollment

40 participants

Start Date

Oct 19, 2023

Study Type

INTERVENTIONAL

Conditions

Relapsed Advanced Lymphomas

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

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called AUR108 in people with relapsed or refractory Hodgkin or non-Hodgkin lymphoma (blood cancers affecting lymph nodes). The goal is to evaluate how safe and effective AUR108 is as a treatment option. **You may be eligible if:** - You are 18 or older with a confirmed diagnosis of Hodgkin or non-Hodgkin lymphoma at advanced stage (Stage III or IV) - Your lymphoma has relapsed or did not respond to prior treatment - Your blood counts and organ function meet minimum requirements - You are able to swallow oral medications **You may NOT be eligible if:** - You have not yet received standard treatment that could potentially cure your disease (such as stem cell transplant) if it is appropriate for your case - You have active brain metastases or uncontrolled central nervous system disease - You have active autoimmune disease or are on immunosuppressive therapy - You are pregnant or breastfeeding 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAUR108

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

Locations(27)

Omega Cancer Hospitals

Visakhapatnam, Andhra Pradesh, India

Post Graduate Institute of Medical Education & Research,

Chandigarh, Chandigarh, India

Cellcure Care Cancer Pvt Ltd

Ahmedabad, Gujarat, India

HCC Happiness Care and Cure Multispeciality Hospital

Ahmedabad, Gujarat, India

Shankus Hospital Pvt. Ltd.

Ahmedabad, Gujarat, India

Unique Hospital

Surat, Gujarat, India

Kiran Multi Speciality Hospital

Surat, Gujarat, India

Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences

Rohtak, Haryana, India

Super Specialty Hospital (G.M.C) Srinagar

Srinagar, Jammu and Kashmir, India

KLES Dr Prabhakar Kore Hospital and MRC

Belagavi, Karnataka, India

Amrita Institute of Medical Sciences (AIMS)

Kochi, Kerala, India

Sujan Surgical Cancer Hospital and Amravati Cancer Foundation

Amravati, Maharashtra, India

Dr. Bafna's Star Superspeciality Clinic & Hospital

Kolhāpur, Maharashtra, India

Kolhapur Cancer Centre

Kolhāpur, Maharashtra, India

Mumbai Onco Care Centre

Mumbai, Maharashtra, India

All India Institute of Medical Sciences

Nagpur, Maharashtra, India

HCG Manavata Cancer Centre

Nashik, Maharashtra, India

Deenanath Mangeshkar Hospital & Research Center

Pune, Maharashtra, India

Sahyadri Super Specialty Hospital

Pune, Maharashtra, India

Sushrut Hospital

Pune, Maharashtra, India

Armed Forces Medical College

Pune, Maharashtra, India

Sunact Cancer Institute Pvt. Ltd

Thane, Maharashtra, India

Rajiv Gandhi Cancer Institute and Research Centre

Delhi, National Capital Territory of Delhi, India

All India Institute of Medical Sciences

Delhi, New Delhi, India

Sparsh Hospital and Critical Care (P) Ltd.

Bhubaneswar, Odisha, India

MNJ Institute of Oncology & Regional Cancer Centre

Hyderabad, Telangana, India

Tata Medical Center

Kolkata, West Bengal, India

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05984147

Related Trials

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

NCT0675545019 locations