NCT05584709

Study to Access Anti-CD38 Anibody Drug in Patients With Advanced Solid Tumors

A Phase 1B, Open-Label, Dose-Escalation Study of the Safety and Efficacy of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Sorrento Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a Phase 1b, single-center, open-label, dose-finding trial designed to identify the Recommended Phase 2 Dose (RP2D) of STI 6129 by assessing the safety, preliminary efficacy, and immunogenicity in subjects with any advanced solid tumor. The patients that will be treated with STI-6129 in this trial are advanced solid tumor patients who have received prior lines of treatment.

Detailed description

The study is a sequential cohort ascending dose (3+3 methodology after a sentinel at the 0,25 mg/kg level) study to confirm safety and identify DLTs in the study population and determine the maximum tolerated dose (MTD) and the RP2D. The range of proposed doses includes optimal doses identified in parallel safety studies of STI-6129 for the treatment of relapsed/refractory systemic amyloid light chain (AL) amyloidosis that are currently ongoing (a three-stage, multicenter, open-label, dose -finding, Phase 1 trial to identify the RP2D). STI-6129 will be given as an intravenous (IV) infusion. Each patient enrolled will received repeated 4-week cycles of STI-6129 (Q4W) Total duration will vary according to patient response. After the treatment period, patients will be monitored for up to 2 years.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	STI-6129	Repeated 4-week intravenous infusion cycles of STI-6129 will be given. (one infusion every four weeks).

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-08-01
• Completion: 2025-10-01
• First posted: 2022-10-18
• Last updated: 2023-01-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study