Phase 1b Study of ST-067 (Decoy-Resistant IL-18) With Teclistamab in Multiple Myeloma

Description

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 period of improvement (relapsed) or that has not responded to previous treatment (refractory). ST-067 is an engineered variant of the human cytokine interleukin-18 that may help the immune system kill cancer cells. Teclistamab is a bispecific antibody that can bind to two different antigens at the same time. Teclistamab binds to B-cell maturation antigen (BCMA), a protein found on some B-cells and myeloma cells, and CD3 on T-cells (a type of white blood cell) and may interfere with the ability of cancer cells to grow and spread. Giving ST-067 in combination with teclistamab may be safe, tolerable and/or effective in treating patients with relapsed or refractory multiple myeloma.OUTLINE: This is a dose-escalation study of ST-067 in combination with teclistamab followed by a dose-expansion st

Trial Eligibility

Inclusion Criteria: * 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 Criteria: * 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, including investigational drugs, within 7 days of study screening * Known central nervous system (CNS) involvement of MM at time of study screening * 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

Study Info

Interventions

Locations Recruiting

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