RecruitingPhase 1NCT05607199

A First in Human Study of AUR 103 Calcium to Evaluate Safety, Pharmacokinetics and Pharmacodynamics

A Phase I, Open Label, Dose-Escalation, First in Human (FIH) Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AUR103 Calcium in Patients With Relapsed Advanced Malignancies( BHARAT-1)


Sponsor

Aurigene Discovery Technologies Limited

Enrollment

80 participants

Start Date

Sep 16, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

A Phase I, Open Label, Dose-Escalation, First in Human (FIH) study evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AUR103 Calcium in patients with relapsed advanced malignancies (BHARAT-1).


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This is the first human study of a new drug called AUR103, testing its safety, how the body processes it, and early signs of whether it works. It is open to adults with advanced solid tumors (Part 1) or acute myeloid leukemia (Part 2). **You may be eligible if...** - You are 18 years or older - You have a confirmed solid tumor (Part 1) that has not responded to at least 2 prior lines of treatment, OR - You have acute myeloid leukemia (Part 2) meeting specific criteria - You are willing and able to comply with all study visits and procedures **You may NOT be eligible if...** - You have not yet tried at least 2 standard therapies - You have significant organ dysfunction, active infections, or serious heart conditions - You are pregnant or breastfeeding (check with your doctor for full exclusion details) 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

DRUGAUR103

Twice Daily


Locations(5)

Unique Hospital

Surat, Gujarat, India

Kiran Multi Super Specialty Hospital

Surat, Gujarat, India

K R Hospital

Mysore, Karnataka, India

Grant Medical Foundation Ruby Hall Clinic

Pune, Maharashtra, India

All India Institute of Medical Sciences

Delhi, India

View Full Details on ClinicalTrials.gov

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NCT05607199


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