RecruitingPhase 1NCT06761586

A Study of AUR104 in Patients With Relapsed/Refractory Lymphoid Malignancies (VIJAY-1)

A Phase 1, Open Label, Dose Escalation, Multicenter Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Oral AUR104 in Patients With Select Relapsed/Refractory Lymphoid Malignancies (VIJAY-1)


Sponsor

Aurigene Discovery Technologies Limited

Enrollment

42 participants

Start Date

Dec 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, open-label, Phase 1 study of AUR104 in adult patients with select Relapsed/Refractory (R/R) Lymphoid Malignancies. The main objective of the study is to evaluate the safety and tolerability of the study drug AUR104.In this study, safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AUR104 will be evaluated in dose escalation manner.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called AUR104 in people with blood cancers — including chronic lymphocytic leukemia (CLL) and various lymphomas — that have come back after treatment or stopped responding. **You may be eligible if...** - You are 18 or older - You have a relapsed or treatment-resistant lymphoid cancer (such as CLL, follicular lymphoma, diffuse large B-cell lymphoma, or related blood cancers) - You are in reasonably good health (ECOG 0–1) - Your blood counts and organ function meet required levels **You may NOT be eligible if...** - Your blood counts are too low (severe anemia, low platelets, or low white blood cells) - Your liver function is significantly impaired - You have active uncontrolled infections - You have conditions that would make the study unsafe for you 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

DRUGAUR104

Once or twice a day


Locations(5)

Kiran Multi Super Speciality Hospital and Research Centre

Surat, Gujarat, India

Sunshine Global Hospitals

Surat, Gujarat, India

Adwaita Cancer Hospital & ICU

Surat, Gujarat, India

Kolhapur Cancer Centre Pvt. Ltd.

Kolhāpur, Maharashtra, India

MMFHA Joshi Hospital

Pune, Maharashtra, India

View Full Details on ClinicalTrials.gov

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NCT06761586