NCT05692908

An Open-Label Study of the Safety of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With AL Amyloidosis

An Open-Label, Dose-Escalation Study of the Safety of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With Relapsed or Refractory Systemic AL Amyloidosis

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sorrento Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 open-label, dose escalation trial designed to identify the recommended phase 2 dose of STI-6129 by assessing the safety, preliminary efficacy, and immunogenicity in subjects with relapsed or refractory systemic AL Amyloidosis

Detailed description

This study is an open-label, dose-finding, to identify the recommended phase 2 dose (RP2D) of STI-6129 by assessing the safety, and pharmacokinetics for the treatment of RRAL which is defined as the development of disease progression during therapy with an anti-AL amyloidosis treatment regimen or within 60 days of the last dose of an anti-AL amyloidosis treatment regimen or the achievement of less than a PR after ≥ 2 cycles. The trial is the dose-escalation study. A standard dose escalation 3+3 will be utilized to identify dose-limiting toxiticy (DLTs) and a safe maximum tolerated dose (MTD) of STI-6129 in patients with R/R systemic AL amyloidosis. A total of 6 dosing cohorts are planned from 0.88 mg/kg to 3.68 mg/kg. Approximate dosing increments between cohorts are 1.33x up to the maximum planned dose level.

Conditions

• Light Chain (AL) Amyloidosis

Interventions

Type	Name	Description
BIOLOGICAL	STI-6129	Four cycles of intravenous infusion of STI-6129 will be given (one infusion every four weeks).

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-09-01
• Completion: 2024-11-01
• First posted: 2023-01-20
• Last updated: 2023-04-28

Regulatory

• FDA-regulated drug study