A Study Evaluating the Safety and Efficacy of AUR108 in Patients With Relapsed Advanced Lymphomas… (NCT05984147) | Clinical Trial Compass
RecruitingPhase 1
A Study Evaluating the Safety and Efficacy of AUR108 in Patients With Relapsed Advanced Lymphomas (ASHA-1)
India40 participantsStarted 2023-10-19
Plain-language summary
An open-label, first-in-human, Phase 1 study in adult patients with relapsed advanced lymphomas will be done to assess AUR108 safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion criteria
✓. Males or 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:
✓. Platelet count ≥ 75,000/μL without 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)
Exclusion criteria
✕. Systemic anti-cancer therapy, such as chemotherapy, or biological therapy, immunomodulatory drug therapy, received within the past 28 days or 5 half-lives, whichever is longer, from the Cycle 1 Day 1 of the study.
✕. Presence of an acute or chronic toxicity resulting from prior anticancer treatment, with the exception of alopecia or nail changes, that has 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
1. First cycle Dose Limiting Toxicities (DLT)
Timeframe: 28 Days
2
Safety of AUR108 as measured by the number of participants with treatment-related adverse events (AE) graded according to NCI CTCAE version 5.0
Timeframe: Through study completion, an average of 1 year
3
Pharmacokinetics Maximum Concentration (Cmax)
Timeframe: Day 1 and Day 17
4
Pharmacokinetics: Time to Maximum concentration (Tmax)
Timeframe: Day 1 and Day 17
5
Pharmacokinetics: Area under the curve (AUC)
Timeframe: Day 1 and Day 17
6
Pharmacokinetics: Terminal elimination half-life
Timeframe: Day 17
7
Maximum concentration (Cmax) administered under fasting/fed condition
Timeframe: Day 8
8
Time to Maximum concentration (Tmax) administered under fasting/fed condition
✕. Known symptomatic or untreated or recently treated (≤ 6 months of screening) central nervous system (CNS) lymphoma. Patients with previously treated (\> 6 months of screening) CNS lymphoma and are now stable and asymptomatic, from CNS perspective, are allowed
✕. Patients with lymphoma that requires immediate cytoreductive therapy
9
Area under curve (AUC) administered under fasting/fed condition