A Phase 1 Clinical Trial of AUR106 in Patients With Relapsed Advanced Malignancies (NCT05861947) | Clinical Trial Compass
TerminatedPhase 1
A Phase 1 Clinical Trial of AUR106 in Patients With Relapsed Advanced Malignancies
Stopped: Patient recruitment problems
India21 participantsStarted 2023-08-26
Plain-language summary
A Phase I, Open Label, Dose-Escalation, First in Human (FIH) Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AUR106 in Patients with Select Relapsed Advanced Malignancies (JIVAN).
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion criteria
✓. Provide signed and dated informed consent and agree to comply with all study related activities.
✓. Male or female patients aged ≥ 18 years.
✓. Patients have to meet the following criteria:
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Patients with disease related ECOG 2 are allowed, in addition to ECOG 0 and 1).
✓. Acceptable bone marrow as described below:
✓. Acceptable organ function as described below:
✓. Ability to swallow and retain oral medications.
✓. Negative serum pregnancy test in women of childbearing potential (WOCBP).
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 the Cycle 1 Day 1 of the study.
✕. Presence of an acute or chronic toxicity resulting from prior anti-cancer 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
Optimal Biological Dose (OBD)
Timeframe: First 28 Days (Cycle 1)
2
Dose Limiting Toxicity (DLT)
Timeframe: First 28 Days (Cycle 1)
3
Pharmacokinetics: Area under the curve (AUC)
Timeframe: Day 1 and Day 15
4
Pharmacokinetics: Maximum concentration Pharmacokinetics: Maximum concentration
. Use of any investigational agent within 28 days 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) 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).
✕. Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome-related illness.
✕. Known active or chronic hepatitis B or hepatitis C infection.