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):
- Has pathologically confirmed advanced or metastatic malignancy characterized by one or more of the following: a. Patient is intolerant of existing therapy(ies) known to provide clinical benefit for their condition b. Malignancy is refractory to existing therapy(ies) known to potentially provide clinical benefit c. Malignancy has progressed after standard therapy
- Has evaluable or measurable tumor(s) in dose escalation by standard radiological and/or laboratory assessments as applicable to their malignancy.
- Eastern Co-operative Oncology Group (ECOG) PS 0-1
- Must be 18 years of age or older
- Other criteria may apply
- Exclusion Criteria (Key Factors):
- Receiving cancer treatment at the time of enrollment
- Any clinically significant disease or condition affecting a major organ system
- Significant cardiovascular disease or electrocardiogram (ECG) abnormalities
- Use of a strong inhibitor or stong inducer of CYP3A4 within 7 days prior to start of study therapy and throughout the study (e.g., some antibiotics, antifungals, anticonvulsants, grapefruit)
- Has had a previous (within 2 years) or has a current malignancy other than the target cancer
- Other exclusions may apply
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