Status:
TERMINATED
ST-067 and Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Simcha Therapeutics
Conditions:
Recurrent Multiple Myeloma
Refractory Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase Ib trial tests the safety, side effects and best dose of ST-067 in combination with teclistamab and how well it works in treating patients with multiple myeloma that has come back after a p...
Detailed Description
OUTLINE: This is a dose-escalation study of ST-067 in combination with teclistamab followed by a dose-expansion study. Patients receive ST-067 subcutaneously (SC) on days 1, 8, 15 and 22 of cycle 1, ...
Eligibility Criteria
Inclusion
- Multiple myeloma, as defined by the presence of at least one International Myeloma Working Group (IMWG) MM-defining event
- Measurable disease as defined by IMWG criteria, requiring one or more of the following:
- Serum M-protein ≥ 0.5 g/dL
- Urine M-protein ≥ 200 mg/24h
- Involved serum free light chain ratio ≥ 10 mg/dL with abnormal kappa/lambda ratio
- Measurable plasmacytoma, defined as ≥ 1 lesion with cross-sectional diameter ≥ 2 centimeters)
- Bone marrow plasma cell percentage ≥ 30%
- Eligibility to receive commercial tec per the Food and Drug Administration (FDA) package insert. This requires (1) at least 4 prior lines of therapy including a proteasome inhibitor (PI), immune modulatory imide drug (IMID), and CD38 monoclonal antibody (mAb); and (2) refractoriness, intolerance, or ineligibility (as deemed by the patient's treating physician) to other established therapies known to provide clinical benefit in MM
- If the FDA package insert for tec is changed to allow for its use in earlier lines of therapy, the above-mentioned stipulations still apply until a protocol modification is approved
- Age ≥ 18 at study screening
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- Anticipated survival of \> 3 months
- Estimated glomerular filtration rate (eGFR) ≥ 40 mL/min using the Modification of Diet in Renal Disease equation
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) both ≤ 3 x the lab's upper limit of normal (ULN)
- Total bilirubin ≤ 2 x ULN
- Platelets ≥ 25,000/μL at screening (no more than 1 transfusion in the 7-day period leading up to screening labs)
- Hemoglobin ≥ 7 g/dL at screening (no more than 1 transfusion in the 7-day period leading up to screening labs)
- Absolute neutrophil count (ANC) ≥ 1000 cells/mm\^3 at screening (no more than one administration of growth factor in the 7-day period leading up to screening labs)
- For patients of reproductive potential only: Willingness to use an effective contraceptive method before, during, and for at least 5 months after the last dose of study therapy
- Ability to understand and provide informed consent as well as willingness to comply with study requirements including visits and biopsies
Exclusion
- History of prior BCMA-directed therapy in the past 12 months
- History of another primary malignancy that has not been in remission for at least 1 year
- However, the following diagnoses are eligible for inclusion: non-melanoma skin cancer, localized prostate cancer, superficial bladder cancer, cervical carcinoma in situ, or any prior malignancy with an estimated \> 90% 1-year cure rate per sponsor-investigator
- Any condition requiring systemic treatment with corticosteroids (\> 10mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study drug administration. This includes active cytokine release syndrome (CRS), active graft-versus-host disease, or autoimmune conditions
- Inhaled or topical steroids are allowed, as are replacement corticosteroids for adrenal insufficiency
- Concurrent use of other anti-MM agents or therapies, including investigational drugs, within 7 days of Cycle 1 Day 1
- Corticosteroids for other purposes, including for pain control, are allowed during the screening period but must also be stopped ≥ 7 days prior to Cycle 1 Day 1
- Similarly, focal radiation therapy for palliative purposes is permitted during the screening period but must also be completed ≥ 7 days prior to Cycle 1 Day 1
- Known central nervous system (CNS) involvement of MM at time of study screening
- Known active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at time of study screening
- Current pregnancy or breastfeeding, or planned pregnancy or breastfeeding within the next 12 months
- Corrected QT (QTc) interval (Bazett formula) ≥ 500 milliseconds on screening electrocardiogram (ECG)
- Uncontrolled or concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Key Trial Info
Start Date :
December 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2025
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT06588660
Start Date
December 18 2024
End Date
February 14 2025
Last Update
July 29 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109