RecruitingPhase 1NCT05605119

First in Human, Dose Escalation, Dose Expansion Study of AUR105

A Phase 1, Open Label, Dose Escalation, Dose Expansion, Multicenter, First in Human (FIH) Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of Oral AUR105 in Patients With Relapsed Advanced Malignancies (SURYA-1)


Sponsor

Aurigene Discovery Technologies Limited

Enrollment

40 participants

Start Date

Nov 30, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multi-center, open-label, First in Human, Phase 1 study of AUR 105 in adult patients with advanced malignancies. The study will have two parts: a Dose Escalation Part and Dose Expansion Part.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase study testing a new investigational cancer drug called AUR105 for the first time in humans. The study is looking at safe doses and how the drug behaves in the body. It is open to adults with advanced solid tumors or lymphomas that have not responded to standard treatments. **You may be eligible if...** - You are 18 years or older - You have an advanced solid tumor or non-Hodgkin/Hodgkin lymphoma confirmed by biopsy - You have measurable disease and have received at least 2 prior lines of treatment - Your performance status is good (ECOG 0 or 1) - Your blood counts, kidney, and liver function are adequate **You may NOT be eligible if...** - You recently received other cancer treatments or investigational drugs (within 4 weeks or 5 half-lives) - You have active, uncontrolled brain metastases - You have leukemia, myelodysplastic syndrome, or multiple myeloma - You have active HIV, hepatitis B or C, or serious heart problems - 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

DRUGAUR105

Once daily


Locations(9)

HCG City Cancer Center

Vijayawada, Andhra Pradesh, India

Omega Hospitals

Visakhapatnam, Andhra Pradesh, India

Kailash Cancer Hospital and Research Centre

Vadodara, Gujarat, India

Krupamayi Hospital

Aurangabad, Maharashtra, India

Moraya Multi-Speciality Hospital

Pune, Maharasthra, India

Sparsh Hospital and Critical Care

Bhubaneswar, Odisha, India

All India Institute of Medical Sciences

Bhubaneswar, Odisha, India

IMS&SUM Hospital

Bhubaneswar, India

ALL India Institute of medical Scieneces

New Delhi, India

View Full Details on ClinicalTrials.gov

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

Visit

NCT05605119


Related Trials