Status:
ACTIVE_NOT_RECRUITING
Study to Assess Anti-CD38 Antibody Drug Conjugate in Relapsed or Refractory Multiple Myeloma
Lead Sponsor:
Sorrento Therapeutics, Inc.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05308225
Start Date
February 1 2023
End Date
July 1 2026
Last Update
April 12 2023
Active Locations (3)
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1
NYU Lagone Health
New York, New York, United States, 10016
2
Columbia University Medical Center
New York, New York, United States, 10032
3
Gabrail Cancer Center
Canton, Ohio, United States, 44718