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 range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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 cutaneous lymphomas, mycosis fungoides (MF) or Sézary syndrome (SS).
. Primary CNS lymphoma
. 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
Time to Maximum concentration (Tmax) administered under fasting/fed condition
Timeframe: Day 8
9
Area under curve (AUC) administered under fasting/fed condition