NCT04671251

Phase 1b Study of AEVI-007 in Subjects With Relapsed or Refractory Multiple Myeloma

A Multicenter, Open-Label, Dose-Escalation Phase 1b Study of AEVI-007 in Subjects With Relapsed or Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Avalo Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, dose-escalation Phase 1b study of AEVI-007 in subjects with relapsed or refractory Multiple Myeloma. The objectives of the study are to evaluate the safety, pharmacokinetics and pharmacodynamics of AEVI-007.

Detailed description

This was a multicenter, open-label, dose-escalation, sequential groups Phase 1b clinical study in subjects with R/R multiple myeloma. The study utilized a "3+3" design. Three subjects were enrolled at each dose, starting with the initial dose of 4 mg/kg. If there were no DLTs, escalation to the next cohort took place. If there was 1 DLT, then the cohort was to be expanded to 6. If there were no further DLTs, then escalation to the next dose took place. If there were 2 DLTs in the initial 3 subjects, or 2 in the expanded cohort of 6 subjects, then the maximally tolerated dose (MTD) had been exceeded and dose escalation stopped. The dose prior to the dose where DLT was observed was then the RP2D. To allow safety assessment, the dosing of subjects within each dose level was staggered, with at least 24 hours between each subject.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	AEVI-007	50 mg of AEVI-007 and will be reconstituted with 1.2 mL of water for injection.

Timeline

• Start date: 2020-12-15
• Primary completion: 2022-03-30
• Completion: 2022-03-30
• First posted: 2020-12-17
• Last updated: 2024-02-29

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study