A Study Evaluating the Safety and Efficacy of AUR107 in Patients With Relapsed Advanced Malignanc… (NCT05865002) | Clinical Trial Compass
RecruitingPhase 1
A Study Evaluating the Safety and Efficacy of AUR107 in Patients With Relapsed Advanced Malignancies (SHAKTI-1)
India50 participantsStarted 2023-09-05
Plain-language summary
An open-label, first-in-human, Phase 1 study in adult patients with relapsed advanced malignancies will be done to assess AUR107 safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose.
Who can participate
Age range18 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:
✓. Platelet count ≥ 100,000/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, 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 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
First cycle Dose Limiting Toxicities (DLT)
Timeframe: 28 days
2
Safety of AUR107 as measured by the number of participants with treatment-related adverse events (AE) graded according to NCI CTCAE version 5.0
Timeframe: 28 days
3
Optimal Biological Dose
Timeframe: 28 days
4
Pharmacokinetics: Maximum concentration (Cmax)
Timeframe: Day 1 and Day 15
5
Pharmacokinetics: Time to Maximum concentration (Tmax)
. Use of drugs which are moderate / strong CYP3A4 inducers and/or drugs which are predominantly metabolized by CYP3A4 within 1week or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
✕. Known symptomatic or untreated or recently treated (≤ 6 months of screening) central nervous system (CNS) metastases. Patients with previously treated (\> 6 months of screening) CNS metastases and are now stable and asymptomatic, from CNS perspective, are allowed.
✕. Major surgery ≤ 28 days from Cycle 1 Day 1 (major surgery is defined as a procedure requiring general anesthesia).
✕. Patients with leukemia, myelodysplastic syndrome, multiple myeloma, or lymphoma.
✕. Active infection requiring systemic therapy. Note: Prophylactic use of antibiotics is allowed. Any infection detected during the screening period which is resolved adequately according to investigator before the Cycle 1 Day 1, is allowed.
Maximum concentration (Cmax) administered under fasting/fed condition
Timeframe: Day 8 and Day 9
10
Time to Maximum concentration (Tmax) administered under fasting/fed condition
Timeframe: Day 8 and Day 9
11
Area under curve (AUC) administered under fasting/fed condition