Study to Assess Anti-CD38 Antibody Drug Conjugate in Relapsed or Refractory Multiple Myeloma

NCT05308225 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 38ADC-RRMM-101
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 3

Brief Summary

This is a two-stage phase 1b/2a, open-label, multicenter, dose-escalation study of STI-6129 administered intravenously once in a 4-week cycle in subjects with relapsed or refractory multiple myeloma.

Conditions

Multiple Myeloma

Keywords

multiple myeloma; relapsed refractory multiple myeloma

Outcome Measures

Primary Outcomes (1)

• Safety of STI-6129

  Safety as assessed by incidence of adverse events (AEs), severe AEs (SAEs), DLTs, neurotoxicity and laboratory abnormalities using the Common Terminology Criteria for Adverse Events (CTCAE Version 5)

  Baseline through study completion at up to approximately 24 months

Secondary Outcomes (3)

• Measuring Pharmacokinetic [PK] Profile

  Baseline through study completion at up to approximately 24 months

• Overall response and duration

  Baseline through study completion at up to approximately 24 months

• Assess preliminary efficacy

  Baseline through study completion at up to approximately 24 months

Study Arms (1)

STI-6129

EXPERIMENTAL

Seven dosing cohorts will be evaluated: 0.67 mg/kg, 0.88 mg/kg, 1.18 mg/kg, 1.56 mg/kg, 2.08 mg/kg, 2.77 mg/kg, 3.68 mg/kg where STI-6129 will be intravenously administered once as part of a 4-week treatment cycle.

Biological: STI-6129

Interventions

STI-6129 BIOLOGICAL

Anti-CD38 A2 human antibody drug conjugate (ADC) containing an antibody covalently bound to a duostatin tubulin inhibitor

STI-6129

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have relapsed or refractory multiple myeloma (RRMM) after having received prior lines of anti-myeloma treatments, including being refractory to a proteasome inhibitor, immunomodulatory agent and an anti-CD38 monoclonal antibody
• Measurable disease as defined by one of the following: abnormal serum or M-protein levels; abnormal serum free light chain (FLC) assay; ≥ 30% clonal plasma cells in the bone marrow aspirate or biopsy sample
• Pulse oximetry ≥ 92% on room air
• Eastern Cooperative Oncology Group (ECOG) performance of 0 - 2
• Be willing and able to comply with the study schedule and all study requirements
• Willing to follow contraception guidelines

You may not qualify if:

• Prior systemic anti-tumor therapy or an investigational drug within 5 half-lives or 4 weeks of D1, whichever is shorter, preceding the first dose of study drug
• Prior treatment with allogeneic hematopoietic stem cell transplantation within 6 months, has active graft versus host disease following transplant or currently receiving immunosuppressive therapy following transplant
• Diagnosis of other malignancies if the malignancy required therapy in the last 3 years or is not in complete remission
• Current history of CTCAE Grade 3 muscle paresis or ocular disorders that are Grade 3 or 2
• Has any clinically significant low baseline lab results for hemoglobin, platelet counts, and neutrophil counts at screening
• Abnormal INR or aPTT, unless on a stable dose of an anticoagulant
• Has ≥ Grade 3 neuropathy or Grade 2 neuropathy with associated pain
• Has any clinically significant baseline lab results for creatinine clearance, serum aspartate aminotransferase, alanine aminotransferase, total bilirubin
• New York Heart Association Class \> 2
• Left ventricular ejection fraction \< 40%
• Prolonged QTcF interval on a 12-lead electrocardiogram
• Has active COVID-19 infection, and not present with symptoms within 4 weeks of study drug
• Has an active bacterial, viral, or fungal infection
• Has known HIV or acquired immunodeficiency syndrome-related illness, acute or history of chronic hepatitis B or C
• Is currently pregnant or breast feeding or planning on either during the study

Sponsors & Collaborators

• Sorrento Therapeutics, Inc.: lead

Study Sites (3)

NYU Lagone Health

New York, New York, 10016, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Rajshekar Chakraborty, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• David Kaminetzky, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: To determine DLT and MTD, the design uses a 3+3 design for the dose-escalation stage.

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: April 4, 2022
• Study Start: February 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

US (3)