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A Phase I/II, Open Label, Multi-center, Non-randomized Dose Escalation and Dose Expansion Study of AMXI-5001 in Patients with Advanced Malignancies
ATLAS-101 is a Phase I/II clinical trial of AMXI-5001 in adult participants with advanced malignancies who have previously failed other therapies. The study has two phases. The purpose of Phase I (Dose Escalation) is to confirm the appropriate treatment dose and Phase II (Dose Expansion) is to characterize the safety and efficacy of AMXI-5001.
The primary objectives of this study are: To evaluate the safety and tolerability of AMXI-5001 To describe any dose-limiting toxicity (DLT) To determine the maximum tolerated dose (MTD) or highest protocol-defined doses (in the absence of exceeding the MTD) To determine the Recommended Phase 2 Dose (RP2D) for AMXI-5001 as monotherapy The secondary objectives of this study are: To determine the preliminary efficacy of AMXI-5001 in tumors with BRCA mutation, either germ line or somatic, after progression on PARP inhibitors To assess the pharmacokinetics of AMXI-5001
Inclusion Criteria (Key Factors):
Exclusion Criteria (Key Factors):