NCT04787042 · Simcha IL-18, Inc.
Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067
What this study is about
This is a multiphase, conducted at multiple hospitals study, which includes a Phase 1a where both patients and doctors know the treatment given, gradually increasing doses treatment given alone study of ST-067 given as an SC injection with or without obinutuzumab \[Gazyva®\] pre-treatment, by IV infusion, and in combination with pembrolizumab.
View original scientific description
This is a multiphase, multicenter study, which includes a Phase 1a open-label, dose escalation monotherapy study of ST-067 given as an SC injection with or without obinutuzumab \[Gazyva®\] pre-treatment, by IV infusion, and in combination with pembrolizumab. A Phase 2 monotherapy arm is also planned; the exact design of the Phase 2 study elements with respect to formulation and pre-treatment will be determined after completion of the Phase 1 study portion of the trial.
Interventions
BIOLOGICAL
ST-067
ST-067 is an engineered variant of human interleukin-18.
BIOLOGICAL
Obinutuzumab 25 MG/1 ML Intravenous Solution [GAZYVA]
Obinutuzumab is a humanized anti-CD20 monoclonal antibody of the IgG1 subclass. It recognizes a specific epitope of the CD20 molecule found on B-cells.
BIOLOGICAL
pembrolizumab
Pembrolizumab is a potent humanized immunoglobulin G4 monoclonal antibody.
Primary outcome measures
Determine the maximum tolerated dose of ST-067 in phase 1a monotherapy
Time frame: Day 29
Patients will be enrolled at a dose level that is predicted to be the MTD
Evaluate the overall safety and tolerability of ST-067 in combination with pembrolizumab
Time frame: Day 29
In patients experiencing insufficient response to a checkpoint inhibitor (PD-1) therapy administered alone or in combination.
Number of Participants With Treatment-Related Adverse Events
Time frame: Day 29
AE assessed by CTCAE 5.0
Initial assessment of efficacy in phase 2
Time frame: At 8 weeks
Investigator-assessed ORR, defined as either a complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on computed tomography (CT) or magnetic resonance imaging (MRI) scans
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male and female patients aged ≥18 years 2. Must provide written informed consent and any authorizations required by local law 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 4. Have histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumor For Phase 1a, the following solid tumors are allowed: Melanoma, Merkel cell, RCC, urothelial, NSCLC,TNBC, SCCHN, microsatellite instability high, high tumor mutation burden (Hi TMB) or mismatch repair deficient, gastric, cervical, endometrial, cutaneous squamous, small cell lung, esophageal, hepatocellular carcinoma and platinum resistant ovarian cancer. 1. For patients who have developed disease progression through standard therapy, or 2. For patients whom standard of care therapy that prolongs survival is unavailable or unsuitable (according to the investigator and after consultation with the Medical Monitor) For Phase 1 combination therapy dose escalation, the
Where
- Scottsdale, Arizona
- Denver, Colorado
- New Haven, Connecticut
- Tampa, Florida
- Boston, Massachusetts
- Buffalo, New York
Collaborators
Merck Sharp & Dohme LLC
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 15, 2024 · Source of record for eligibility and locations