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Phase 1a and 2 Study of ST-067 for Advanced Solid Tumors

This study is testing a new treatment called ST-067, which is a modified version of a natural body protein (interleukin-18). It's being studied alone, with obinutuzumab (a drug that targets certain immune cells), and with pembrolizumab (an immunotherapy drug). The study aims to find the safest and most effective dose of ST-067 and see how well it works against various advanced solid tumors, including melanoma, kidney cancer (renal cell carcinoma), and triple-negative breast cancer. Researchers will also look at how the body handles ST-067 and its effects. You may be eligible if you are 18 or older with an advanced solid tumor. The study is currently unclear on its recruitment status.

Study design
This is a multi-phase, multi-center study with an open-label design. It plans to enroll 316 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and side effects will be checked for each participant throughout the study. Initial safety and tolerability are measured at Day 29.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04787042

Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067

Recruiting
PHASE1Ages 18+InterventionalTreatment
Simcha IL-18, Inc.
~316 participants
Updated 2024-11-15 on ClinicalTrials.gov
What's tested:ST-067Obinutuzumab 25 MG/1 ML Intravenous Solution [GAZYVA]pembrolizumab

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine the maximum tolerated dose of ST-067 in phase 1a monotherapy
Measured over Day 29
+3 more outcomes measured

Conditions

Cancer
Solid Tumor
Melanoma
Renal Cell Carcinoma
Triple-negative Breast Cancer
Non Small Cell Lung Cancer
Squamous Cell Carcinoma of the Head and Neck
Carcinoma
MSI-High

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Head and Neck Squamous Cell CarcinomaLung Non-Small Cell CarcinomaMelanomaRenal Cell CarcinomaSolid NeoplasmTriple-Negative Breast CarcinomaMRC1 wt AlleleMSI1 GeneTPM2 wt Allele

Where it's being run

6 sites across 6 states
Arizona1
Colorado1
Connecticut1
Florida1
Massachusetts1
New York1

Study leadership

  • Jeremy Barton, MD · STUDY_DIRECTOR · Simcha IL-18, Inc.

Who to contact

Beatrice McQueen, Ph.D.
[email protected]
805-300-3912
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

TNBC is diagnosed in a tumor which does not express estrogen receptor or progesterone receptor, is not human epidermal growth factor receptor 2 (HER2) 3+ on IHC or is negative by fluorescence in situ hybridization (FISH).
MSI high tumor should have mutations in 30% or more microsatellites by PCR or be negative for MSH1/2/6 or PMS-2 by IHC.
Hi-TMB high tumor has 10 mut/Mb or greater calculated from whole genome sequencing or whole exome sequencing

What this trial measures

  • Determine the maximum tolerated dose of ST-067 in phase 1a monotherapyDay 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 pembrolizumabDay 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 EventsDay 29

    AE assessed by CTCAE 5.0

  • Initial assessment of efficacy in phase 2At 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