Clinical trialNCT04316442UnknownPhase 1/PHASE2Interventional

Study of the Safety and Efficacy of STI-6129 in Patients With Relapsed or Refractory Systemic AL Amyloidosis

SponsorSorrento Therapeutics, Inc.Enrollment60Light Chain (AL) Amyloidosis

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The STI-6129-001 study is a three-stage, multicenter, open-label, dose-finding, phase 1b/2a trial. It is designed primarily to identify the recommended phase 2 dose (RP2D) of STI-6129 by assessing the safety, preliminary efficacy and pharmacokinetics of this anti-CD38-Duostatin 5.2 antibody-drug conjugate (ADC) for the treatment of relapsed or refractory systemic AL amyloidosis. The patients that will be treated with STI-6129 in this trial are relapsed or refractory systemic AL amyloidosis patients who have received prior lines of treatment.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Anita D'Souza, MD
Froedtert Hospital & the Medical College of Wisconsin
Principal Investigator
clinicaltrials.gov ↗
Jeffrey Zonder, MD
Barbara Ann Karmanos Cancer Institute Wertz Clinic
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗
Michael Rosenzweig, MD
City of Hope National Medical Center
Principal Investigator
clinicaltrials.gov ↗
Vaishali Sanchorawala, MD
Boston Medical Center
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

4 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

City of Hope National Medical Center
Duarte, California, United States
Michael Rosenzweig, MD
Recruiting
Boston Medical Center
Boston, Massachusetts, United States
Vaishali Sanchorawala, MD
Recruiting
Barbara Ann Karmanos Cancer Institute Wertz Clinic
Detroit, Michigan, United States
Jeffrey Zonder, MD →
Recruiting
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Anita D'Souza, MD
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

STI-6129

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 1 Apr 2021
Primary completion: 30 Sept 2024
Completion: 31 Dec 2024
Last update posted: 17 Jan 2023
Registered enrollment: 60
Registry id: NCT04316442

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.