Recruiting
Phase 1
Phase 2

STI-6129

Sponsor:

Sorrento Therapeutics, Inc.

Code:

NCT04316442

Conditions

Light Chain (AL) Amyloidosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

STI-6129

Study Details

Brief summary:

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.

Conditions

Light Chain (AL) Amyloidosis

Study ID

NCT04316442

Start date

Apr 1, 2021

Status verified date

Jan, 2023

Completion date

Dec, 2024

Anticipated

Primary completion date

Sep, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Confirmed diagnosis of AL amyloidosis by tissue biopsy of an involved organ, or a surrogate site such as abdominal fat demonstrating amyloid deposition by mass spectrometry
  • The presence of a monoclonal light chain protein in serum
  • Relapsed or refractory AL amyloidosis is defined as patients who have received ≥ 2 lines of treatment. Patients must have received at least one proteasome inhibitor during their prior therapy. Patients who have received prior daratumumab treatment or prior stem cell transplantation remain eligible. Patients may have relapsed with disease progression or have been refractory to their last prior line of treatment. Progression of disease that develops > 60 days after the last dose of a treatment regimen in a patient who achieved at least a partial response (PR) defines a relapse. Refractory systemic AL amyloidosis 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
  • Measurable disease defined as the finding by serum-free light chain (FLC) assay that the difference between the involved and uninvolved FLC (dFLC) is ≥ 50 mg/L
  • Pulse oximetry ≥ 92% on room air
  • ECOG performance status of 0, 1, or 2
  • Willing to comply with the study schedule and all other protocol requirements
  • Females of childbearing potential (FCBP) must have 2 negative pregnancy tests prior to treatment. All heterosexually active FCBP and all heterosexually active male patients must agree to use effective methods of birth control throughout the study

Exclusion Criteria:

  • Isolated vascular amyloid in a bone marrow biopsy or a plasmacytoma specimen or isolated soft tissue involvement (localized AL amyloidosis)
  • Presence of non-AL amyloidosis
  • A diagnosis of multiple myeloma
  • A diagnosis of other malignancies if the malignancy has required therapy within the last 3 years or is not in complete remission. Exceptions are non-metastatic basal cell or squamous cell carcinomas of the skin or prostate cancer that does not require treatment
  • Treatment with an allogeneic hematopoietic stem cell transplantation (HSCT) within 6 months prior to the planned infusion of STI-6129, or active graft-versus-host disease (GVHD) following the allogeneic transplant, or a requirement for currently receiving immunosuppressive therapy following the allogeneic transplant
  • Revised Mayo Clinic AL amyloidosis stage > 3
  • New York Heart Association (NYHA) class > 2
  • Left ventricular ejection fraction (LVEF) < 40%
  • Patients with mean left ventricular wall thickness ≥ 12 mm and/or intraventricular septal thickness > 25 mm by echocardiogram in the absence of hypertension or valvular heart disease
  • Patients with NT-proBNP ≥ 1800 ng/L or BNP ≥ 400 ng/L, or cTNT ≥ 0.025 μg/L will be excluded in the dose-escalation stage of the study and can only be included in the PK and expansion stages after evaluation by cardiology and discussion with the principle investigator regarding the risk associated with the treatment
  • Abnormal baseline hematological laboratory results at Screening:

  • Hemoglobin < 8.0 g/dL
  • Platelet count < 50,000/μL
  • Absolute neutrophil count (ANC) < 1000/μL
  • Abnormal baseline chemistry laboratory results at Screening:

  • Serum creatinine ≥ 2.0 mg/dL or estimated creatinine clearance < 60 mL/min (using the Cockcroft-Gault equation)
  • Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3x the upper limit of normal (ULN) or serum total bilirubin > 1.5x ULN (except for patients in whom hyperbilirubinemia is attributed to Gilbert's Syndrome)
  • INR or aPTT > 1.5x ULN within 1 week prior to the infusion of STI-6129, unless on a stable dose of an anticoagulant
  • Pregnant or breastfeeding
  • Active bacterial, viral, or fungal infection within 72 hours of the infusion of STI-6129; patients with ongoing use of prophylactic antibiotics, antifungal agents, or antiviral agents remain eligible as long as there is no evidence of active infection
  • Have human immunodeficiency virus (HIV) infection, human T-cell leukemia virus type 1 (HTLV1) infection, or hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia or are at risk for HBV reactivation (at risk for HBV reactivation is defined as being HBs antigen positive, or anti-HBc-antibody positive), or are positive for HBV deoxyribonucleic acid (DNA). HCV ribonucleic acid (RNA) must be undetectable by laboratory test
  • QTcF > 470 msec on a baseline ECG
  • Any condition including the presence of laboratory abnormalities that places the patient at unacceptable risk if the patient was to participate in the study

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: STI-6129 infusion

Intravenous infusion to be given with prophylaxis for infusion reactions if necessary.

Interventions

STI-6129

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

Primary outcome measure

  • Safety and tolerability of STI-6129 in AL amyloidosis patients [ Time Frame: Baseline through study completion at up to 14 months ]

Central Contacts and Locations

Central contacts

Ying Yan, MD MS

858-203-4100yyan@sorrentotherapeutics.com

Mike Royal, MD JD MBA

858-203-4100mroyal@sorrentotherapeutics.com

Locations

City of Hope National Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Anju Nair

972-997-8000annair@coh.org

Principal Investigator:

Michael Rosenzweig, MD

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Melissa Difuntorum

617-638-8434melissa.difuntorum@bmc.org

Principal Investigator:

Vaishali Sanchorawala, MD

Barbara Ann Karmanos Cancer Institute Wertz Clinic

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Silva Pregja

313-576-8766pregjas@karmanos.org

Principal Investigator:

Jeffrey Zonder, MD

Froedtert Hospital & the Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Althea Thomas

414-805-2588athomas@mcw.edu

Nicholas Mohrdieck

414-805-6402nmohrdieck@mcw.edu

Principal Investigator:

Anita D'Souza, MD

More Information

Sponsor

Sorrento Therapeutics, Inc.

Last update posted

Jan 17, 2023

Last verified

Jan, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Sorrento Therapeutics, Inc. on 2023-01-17.