A Study of AUR104 in Patients With Relapsed/Refractory Lymphoid Malignancies (VIJAY-1) (NCT06761586) | Clinical Trial Compass
TerminatedPhase 1
A Study of AUR104 in Patients With Relapsed/Refractory Lymphoid Malignancies (VIJAY-1)
Stopped: Patient recruitment problems
India9 participantsStarted 2024-12-12
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion criteria
✓. 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:
✓. Ability to swallow and retain oral medications.
✓. Histopathological diagnosis of Non-Hodgkin Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL) or Hodgkin disease.
Exclusion criteria
✕. 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.
✕. 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).
What they're measuring
1
First cycle DLT
Timeframe: 28 days (Cycle 1)
2
Frequency of Adverse Events
Timeframe: Throughout the study, an average of 1 year
3
Frequency of Serious Adverse Events
Timeframe: Throughout the study, an average of 1 year
4
Pharmacokinetics: Area under the curve (AUC)
Timeframe: Cycle 1 Day 1 and Day 9 (Cohorts 1, 2, and 3); Cycle 1 Day 5 (only Cohort 3) (Each cycle is 28 days)
5
Pharmacokinetics: Maximum plasma concentration (Cmax)
Timeframe: Cycle 1 Day 1 and Day 9 (Cohorts 1, 2, and 3); Cycle 1 Day 5 (only Cohort 3) (Each cycle is 28 days)
6
Pharmacokinetics: Time to Maximum plasma concentration (Tmax)
Timeframe: Cycle 1 Day 1 and Day 9 (Cohorts 1, 2, and 3); Cycle 1 Day 5 (only Cohort 3) (Each cycle is 28 days)
✕. 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.