ST-067 and Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma

NCT06588660 | Terminated Phase 1 DMC FDA Drug

• 3 other identifiers: RG1123948NCI-2024-0723620589
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Recurrent Multiple Myeloma; Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (4)

• Monotherapy dose-limiting toxicities (DLT) rates

  Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded using American Society for Transplantation and Cellular Therapy (ASTCT) criteria, while other toxicities will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. DLT rates at each dose level will be estimated by isotonic regression by applying the pooled adjacent violators algorithm.

  Up to 28 days (cycle 1)

• Combination therapy DLT rates

  CRS and ICANS will be graded using ASTCT criteria, while other toxicities will be graded using CTCAE v 5.0. DLT rates at each dose level will be estimated by isotonic regression by applying the pooled adjacent violators algorithm.

  Up to 28 days (cycle 2)

• Optimal biological dose (OBD)

  OBD will be determined based on a composite of clinical information, including safety, tolerability, optimal biological effects without undesirable clinical effects, and biological response data.

  Up to 28 days

• Incidence of adverse events (AEs)

  The types, frequencies and severity of AEs will be analyzed. CRS and ICANS will be graded using ASTCT criteria, while other toxicities will be graded using CTCAE v 5.0.

  Up to 30 days after last dose of ST-067

Secondary Outcomes (5)

• Overall response rate (ORR)

  At months 1 and 3

• Minimal residual disease (MRD) negativity

  At 1 month after initiation of teclistamab

• Duration of response (DOR)

  Up to 5 years

• Progression-free survival (PFS)

  From first dose of teclistamab to disease progression or death up to 5 years

• Overall survival (OS)

  From first dose of teclistamab to death up to 5 years

Study Arms (1)

Treatment (ST-067, teclistamab)

EXPERIMENTAL

Patients receive ST-067 SC on days 1, 8, 15 and 22 of cycle 1, on days 8, 15 and 22 of cycle 2, then on days 1 and 15 of subsequent cycles. Patients also receive teclistamab SC on days 1, 3, 5, 15 and 22 of cycle 2 then on days 1, 8, 15, and 22 or days 1 and 15 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection throughout the trial and bone marrow aspiration and biopsy during screening and on study.

Biological: Vevoctadekin; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Other: Medical Chart Review; Drug: Teclistamab; Procedure: Biospecimen Collection

Interventions

Vevoctadekin BIOLOGICAL

Given SC

Also known as: Engineered IL-18 Variant ST-067, Engineered Interleukin-18 Variant ST-067, ST 067, ST-067, ST067

Treatment (ST-067, teclistamab)

Bone Marrow Aspiration PROCEDURE

Undergo bone marrow aspiration and biopsy

Treatment (ST-067, teclistamab)

Bone Marrow Biopsy PROCEDURE

Undergo bone marrow aspiration and biopsy

Also known as: Biopsy of Bone Marrow, Biopsy, Bone Marrow

Treatment (ST-067, teclistamab)

Medical Chart Review OTHER

Ancillary studies

Also known as: Chart Review

Treatment (ST-067, teclistamab)

Teclistamab DRUG

Given SC

Also known as: JNJ 64007957, JNJ-64007957, JNJ64007957, Teclistamab-cqyv, Tecvayli

Treatment (ST-067, teclistamab)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection

Treatment (ST-067, teclistamab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Washington: lead
• Simcha Therapeutics: collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Rahul Banerjee, MD

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: December 18, 2024
• Primary Completion: February 14, 2025
• Study Completion: February 14, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)