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

Primary Purpose

Multiple Myeloma

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
STI-6129
Sponsored by
Sorrento Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring multiple myeloma, relapsed refractory multiple myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NYU Lagone Health
  • Columbia University Medical Center
  • Gabrail Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

STI-6129

Arm Description

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Measuring Pharmacokinetic [PK] Profile
STI-6129 blood plasma concentrations will be measured for the total antibody plus conjugated toxin (STI 6129) and the free toxin
Overall response and duration
Response and duration determined according to the International Myeloma Working Group (IMWG) response criteria
Assess preliminary efficacy
As a measure of activity, overall response rate will be assessed according to the modified International Myeloma Working Group (IMWG) criteria.

Full Information

First Posted
March 15, 2022
Last Updated
April 10, 2023
Sponsor
Sorrento Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05308225
Brief Title
Study to Assess Anti-CD38 Antibody Drug Conjugate in Relapsed or Refractory Multiple Myeloma
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorrento Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
multiple myeloma, relapsed refractory multiple myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
To determine DLT and MTD, the design uses a 3+3 design for the dose-escalation stage.
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STI-6129
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
STI-6129
Intervention Description
Anti-CD38 A2 human antibody drug conjugate (ADC) containing an antibody covalently bound to a duostatin tubulin inhibitor
Primary Outcome Measure Information:
Title
Safety of STI-6129
Description
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)
Time Frame
Baseline through study completion at up to approximately 24 months
Secondary Outcome Measure Information:
Title
Measuring Pharmacokinetic [PK] Profile
Description
STI-6129 blood plasma concentrations will be measured for the total antibody plus conjugated toxin (STI 6129) and the free toxin
Time Frame
Baseline through study completion at up to approximately 24 months
Title
Overall response and duration
Description
Response and duration determined according to the International Myeloma Working Group (IMWG) response criteria
Time Frame
Baseline through study completion at up to approximately 24 months
Title
Assess preliminary efficacy
Description
As a measure of activity, overall response rate will be assessed according to the modified International Myeloma Working Group (IMWG) criteria.
Time Frame
Baseline through study completion at up to approximately 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajshekar Chakraborty, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Kaminetzky, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Lagone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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