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

NCT04503265 Phase 1/Phase 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.

Details

Lead sponsor	AtlasMedx, Incorporated
Phase	Phase 1/Phase 2
Status	RECRUITING
Enrolment	122
Start date	2020-08-12
Completion	2026-10

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

Primary outcomes

• Determine the Maximum Tolerated Dose (MTD) — Approximately 12 months
  The highest dose is defined at which no more than 1 of 6 evaluable participants has had a Dose Limiting Toxicity (DLT) according to NCI CTCAE V5.0 criteria and determination by Investigator and Data and Safety Monitoring Committee.
• Determine the Recommended Phase 2 Dose (RP2D) for AMXI-5001 as monotherapy — Approximately 12 months
  The RP2D is based upon the review of all available data including safety, pharmacokinetic, preliminary anti-tumor activity, and MTD.
• Characterize safety profile of AMXI-5001 — Approximately 24 months
  The safety profile of AMXI-5001 is defined by the incidence of treatment emergent adverse events, laboratory abnormalities, and ECG measurements.

Countries

United States