A Phase I/II, Open Label, Multi-center, Non-randomized Dose Escalation and Dose Expansion Study of AMXI-5001 in Patients With Advanced Malignancies

Trial ID: NCT04503265

Interventional - Phase 1/2 - Recruiting

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.

Conditions

• Advanced Malignant Neoplasm
• Breast Cancer
• Ovarian Cancer
• Homologous Recombination Deficiency
• Prostate Cancer
• Pancreatic Cancer

Interventions

• AMXI-5001:Dose Escalation Phase I
• AMXI-5001:Dose Expansion Phase II

Eligibility

Inclusion criteria

• (Key Factors):
• 1. Has pathologically confirmed advanced or metastatic malignancy characterized by one or more of the following:
• 1. Patient is intolerant of existing therapy(ies) known to provide clinical benefit for their condition
• 2. Malignancy is refractory to existing therapy(ies) known to potentially provide clinical benefit
• 3. Malignancy has progressed after standard therapy
• 2. Has evaluable or measurable tumor(s) in dose escalation by standard radiological and/or laboratory assessments as applicable to their malignancy.
• 3. Eastern Co-operative Oncology Group (ECOG) PS 0-1
• 4. Participant must be 18 years of age or older
• 5. Able to understand and sign consent

Exclusion criteria

• (Key Factors):
• 1. Receiving cancer treatment at the time of enrollment
• 2. Any clinically significant disease or condition affecting a major organ system
• 3. Significant cardiovascular disease or electrocardiogram (ECG) abnormalities
• 4. Use of a strong inhibitor or inducer of CYP3A4 within 7 days prior to start of study therapy and throughout the study (e.g., some antibiotics, antifungals, anticonvulsants, grapefruit)
• 5. Has had a previous (within 2 years) or has a current malignancy other than the target cancer

Sponsor

AtlasMedx, Incorporated

Source: ClinicalTrials.gov

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