Study to Assess Anti-CD38 Antibody Drug Conjugate in Relapsed or Refractory Multiple Myeloma
Status unconfirmed · Phase 1/Phase 2
Conditions studied: Multiple Myeloma
In brief
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.
Key facts
- Study ID
- NCT05308225
- Run by
- Sorrento Therapeutics, Inc.
- People needed
- 72
- Starts
- 2023-02-01
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2023-04-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
- 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
Where it is running
- NYU Lagone Health — New York, New York, United States
- Columbia University Medical Center — New York, New York, United States
- Gabrail Cancer Center — Canton, Ohio, United States
Full record on ClinicalTrials.gov
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