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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05308225
Recruitment Status : Recruiting
First Posted : April 4, 2022
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
Sorrento Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: STI-6129 Phase 1 Phase 2

Detailed Description:

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.

The study is designed to identify the recommended phase 2 dose (RP2D) of STI-6129 by assessing the safety, preliminary efficacy and pharmacokinetics using a conventional 3+3 study design for dose escalation in stage one and then the second stage will be an expansion study to assess preliminary efficacy.

Patients will be enrolled sequentially within each cohort and between cohorts during the dose escalation portion of the study with a 28-day cycle of treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description: To determine DLT and MTD, the design uses a 3+3 design for the dose-escalation stage.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b/2a, Open-Label, Dose-Escalation Study of the Safety and Efficacy of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With Relapsed or Refractory Multiple Myeloma
Estimated Study Start Date : September 1, 2022
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: STI-6129
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
Anti-CD38 A2 human antibody drug conjugate (ADC) containing an antibody covalently bound to a duostatin tubulin inhibitor




Primary Outcome Measures :
  1. Safety of STI-6129 [ Time Frame: Baseline through study completion at up to approximately 24 months ]
    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)


Secondary Outcome Measures :
  1. Measuring Pharmacokinetic [PK] Profile [ Time Frame: Baseline through study completion at up to approximately 24 months ]
    STI-6129 blood plasma concentrations will be measured for the total antibody plus conjugated toxin (STI 6129) and the free toxin

  2. Overall response and duration [ Time Frame: Baseline through study completion at up to approximately 24 months ]
    Response and duration determined according to the International Myeloma Working Group (IMWG) response criteria

  3. Assess preliminary efficacy [ Time Frame: Baseline through study completion at up to approximately 24 months ]
    As a measure of activity, overall response rate will be assessed according to the modified International Myeloma Working Group (IMWG) criteria.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Has any significant medical condition, abnormality, or psychiatric illness that would prevent study participation
  • Has any additional clinical history that would place the patient at an unacceptable risk if the patient participates in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05308225


Contacts
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Contact: Mike Royal, MD (858)203-4100 ext 4146 mroyal@sorrentotherapeutics.com

Locations
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United States, Ohio
Gabrail Cancer Center Recruiting
Canton, Ohio, United States, 44718
Sponsors and Collaborators
Sorrento Therapeutics, Inc.
Investigators
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Study Director: Mike Royal, MD Sorrento Therapeutics, Inc.
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Responsible Party: Sorrento Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05308225    
Other Study ID Numbers: 38ADC-RRMM-101
First Posted: April 4, 2022    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sorrento Therapeutics, Inc.:
multiple myeloma
relapsed refractory multiple myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases