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

NCT06761586 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: AUR104-101
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Select Relapsed/Refractory Lymphoid Malignancies

Keywords

Relapsed/Refractory Lymphoid Malignancies; Non-Hodgkin Lymphoma (NHL); Chronic Lymphocytic Leukemia (CLL); Hodgkin Lymphoma (HL)

Outcome Measures

Primary Outcomes (7)

• First cycle DLT

  Assess dose limiting toxicities of AUR104

  28 days (Cycle 1)

• Frequency of Adverse Events

  Adverse Events will be assessed by NCI CTCAE v 5.0

  Throughout the study, an average of 1 year

• Frequency of Serious Adverse Events

  Serious Adverse Events will be assessed by NCI CTCAE v 5.0

  Throughout the study, an average of 1 year

• Pharmacokinetics: Area under the curve (AUC)

  Area under the curve of AUR104

  Cycle 1 Day 1 and Day 9 (Cohorts 1, 2, and 3); Cycle 1 Day 5 (only Cohort 3) (Each cycle is 28 days)

• Pharmacokinetics: Maximum plasma concentration (Cmax)

  Maximum plasma concentration of AUR104

  Cycle 1 Day 1 and Day 9 (Cohorts 1, 2, and 3); Cycle 1 Day 5 (only Cohort 3) (Each cycle is 28 days)

• Pharmacokinetics: Time to Maximum plasma concentration (Tmax)

  Time to Maximum plasma concentration of AUR104

  Cycle 1 Day 1 and Day 9 (Cohorts 1, 2, and 3); Cycle 1 Day 5 (only Cohort 3) (Each cycle is 28 days)

• Pharmacokinetics: Terminal elimination half-life (t½)

  Terminal elimination half-life of AUR104

  Cycle 1 Day 1 and Day 9 (Cohorts 1, 2, and 3); Cycle 1 Day 5 (only Cohort 3) (Each cycle is 28 days)

Other Outcomes (5)

• Exploratory Endpoint: Changes in the expression of genes

  Cycle 1 Day 1, Day 2, Day 15, and Cycle 2 Day 1 (Cohort 1 & 2); Cycle 1 Day 1, Day 6, Day 15, and Cycle 2 Day 1 (Cohort 3) (Each cycle is 28 days)

• Exploratory Endpoint: Changes in the expression of cytokines

  Cycle 1 Day 1, Day 2, Day 15, and Cycle 2 Day 1 (Cohort 1 & 2); Cycle 1 Day 1, Day 6, Day 15, and Cycle 2 Day 1 (Cohort 3) (Each cycle is 28 days) (Each cycle is 28 days)

• Efficacy assessment: Overall response rates (ORR)

  Through study completion, an average of 1 year

Study Arms (1)

AUR104 5mg & 20 mg Tablets

EXPERIMENTAL

Currently planned dose levels are 20 mg QD, 10 mg BID and 15 mg BID.

Drug: AUR104

Interventions

AUR104 DRUG

Once or twice a day

AUR104 5mg & 20 mg Tablets

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females ≥ 18 years of age.
• Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
• Acceptable bone marrow and organ function at screening as described below:
• ANC ≥ 1000/μL (without WBC growth factor support)
• Platelet count: For patients with CLL ≥ 50,000/μL, For patients with lymphomas ≥ 75,000/μL without bone marrow involvement and ≥ 50,000/μL with bone marrow involvement. These thresholds should be qualified without current transfusion support.
• Hemoglobin ≥ 9 g/dL (Transfusion is allowed to achieve this Hb).
• Total Bilirubin ≤ 1.5 x ULN (Patients with known Gilbert's syndrome are allowed with a Total Bilirubin ≤ 2.5 x ULN).
• AST (SGOT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases).
• ALT (SGPT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases).
• Creatinine clearance (CrCl) ≥ 60 mL/min (either measured or estimated by the Cockcroft-Gault formula). Cockcroft-Gault formula for estimated creatinine clearance (eCrCl):(140 - Age) × Weight (kg) × (0.85 if Female)/(72 × serum creatinine in mg/dL).
• Ability to swallow and retain oral medications.
• Histopathological diagnosis of Non-Hodgkin Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL) or Hodgkin disease.
• Note:
• a. The lymphoma should be either in Stage III or IV according to Lugano classification at screening.
• Mature B-cell neoplasms (excluding plasma cell neoplasms, heavy chain disease, and primary central nervous system \[CNS\] lymphoma).

You may not qualify if:

• Systemic anti-cancer therapy, such as chemotherapy, biological therapy, or immunomodulatory drug therapy, received within the past 28 days or 5 half-lives, whichever is longer, from Cycle 1 Day 1 of the study.
• Note: Concomitant use of low-dose prednisone (up to 10 mg/day) is allowed.
• Presence of acute or chronic toxicity resulting from prior anti-cancer treatment, except for alopecia or nail changes that have not resolved to Grade ≤ 1, as determined by NCI CTCAE v 5.0.
• Definitive Radiotherapy within the last 21 days of Cycle 1 Day 1 (limited field palliative radiation is allowed and no restrictions during the screening period or during the trial).
• Use of any investigational agent within 28 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
• Patients with Burkitt's lymphoma, Burkitt-like lymphoma, post-transplant lymphoproliferative disease, primary mediastinal large-B cell lymphoma, cutaneous lymphomas, mycosis fungoides (MF), or Sezary syndrome (SS).
• Known symptomatic or untreated or recently treated (≤ 6 months of screening) central nervous system (CNS) lymphoma. Patients with previously treated (more than 6 months of screening) CNS lymphoma and are now stable and asymptomatic, from a CNS perspective, are allowed.
• Patients with lymphoma requiring immediate cytoreductive therapy.
• Patients with low-grade or indolent lymphoma not meeting conventional criteria for treatment.
• Elevated Serum cardiac Troponin I or troponin T more than ULN at screening.
• Serum magnesium and calcium levels more than 1.2 x ULN or less than 0.8 x LLN.
• Serum Potassium more than 1.0 x ULN or less than 1.0 x LLN. Note: Patients experiencing hypokalemia are permitted to undergo treatment to attain normal potassium levels during the screening period.
• Mean Heart Rate less than 60 at screening or Cycle 1 Day 1 (to be recorded at least 3 times at least 5 minutes apart) in ECG.
• Left ventricular ejection fraction (LVEF) less than 50% as determined by an echocardiogram (ECHO) or Multigated Acquisition (MUGA) scan.
• QTcF (Fridericia) interval more than 450 ms for patients on ECG at screening and/or at Cycle 1 Day 1.

Sponsors & Collaborators

• Aurigene Discovery Technologies Limited: lead

Study Sites (5)

Kiran Multi Super Speciality Hospital and Research Centre

Surat, Gujarat, 395004, India

Location

Sunshine Global Hospitals

Surat, Gujarat, 395007, India

Location

Adwaita Cancer Hospital & ICU

Surat, Gujarat, 395009, India

Location

Kolhapur Cancer Centre Pvt. Ltd.

Kolhāpur, Maharashtra, 416234, India

Location

MMFHA Joshi Hospital

Pune, Maharashtra, 411004, India

Location

MeSH Terms

Conditions

Recurrence; Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell; Hodgkin Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequential Assignment Dose Escalation Design

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: January 7, 2025
• Study Start: December 12, 2024
• Primary Completion: February 10, 2026
• Study Completion: February 10, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (5)