Tampa, FLNCT04787042Now EnrollingIRB Ready

I cannot determine the primary medical condition from the provided information. The study title only mentions "ST-067" (which appears to be an investigational drug), and the conditions listed contain only drug/treatment names (ST-067, Obinutuzumab, and pembrolizumab) rather than medical conditions. The brief summary field appears to be incomplete. Without information about the actual disease or condition being treated, I cannot extract a patient-facing medical condition. Clinical Trial in Tampa, FL

Access cutting-edge i cannot determine the primary medical condition from the provided information. the study title only mentions "st-067" (which appears to be an investigational drug), and the conditions listed contain only drug/treatment names (st-067, obinutuzumab, and pembrolizumab) rather than medical conditions. the brief summary field appears to be incomplete. without information about the actual disease or condition being treated, i cannot extract a patient-facing medical condition. treatment through this phase 1/2 clinical trial at a research site in Tampa. Study-provided care at no cost to qualified participants.

Sponsored by Simcha IL-18, Inc.

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Access i cannot determine the primary medical condition from the provided information. the study title only mentions "st-067" (which appears to be an investigational drug), and the conditions listed contain only drug/treatment names (st-067, obinutuzumab, and pembrolizumab) rather than medical conditions. the brief summary field appears to be incomplete. without information about the actual disease or condition being treated, i cannot extract a patient-facing medical condition. specialists at no cost

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All study-related i cannot determine the primary medical condition from the provided information. the study title only mentions "st-067" (which appears to be an investigational drug), and the conditions listed contain only drug/treatment names (st-067, obinutuzumab, and pembrolizumab) rather than medical conditions. the brief summary field appears to be incomplete. without information about the actual disease or condition being treated, i cannot extract a patient-facing medical condition. treatment provided free

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Check if you qualify for this i cannot determine the primary medical condition from the provided information. the study title only mentions "st-067" (which appears to be an investigational drug), and the conditions listed contain only drug/treatment names (st-067, obinutuzumab, and pembrolizumab) rather than medical conditions. the brief summary field appears to be incomplete. without information about the actual disease or condition being treated, i cannot extract a patient-facing medical condition. clinical trial in Tampa, FL

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Why Participate?

  • No-Cost Study Care

  • Local to Tampa

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Tampa site if eligible
  4. 4Begin participation

About This I cannot determine the primary medical condition from the provided information. The study title only mentions "ST-067" (which appears to be an investigational drug), and the conditions listed contain only drug/treatment names (ST-067, Obinutuzumab, and pembrolizumab) rather than medical conditions. The brief summary field appears to be incomplete. Without information about the actual disease or condition being treated, I cannot extract a patient-facing medical condition. Study in Tampa

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.

Sponsor: Simcha IL-18, Inc.

Who Can Participate

Inclusion Criteria

Male and female patients aged ≥18 years
Must provide written informed consent and any authorizations required by local law
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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.
For patients who have developed disease progression through standard therapy, or
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 following solid tumors are allowed: Melanoma, Merkel cell, RCC, urothelial, NSCLC (with no EGFR, TRK receptor, or ALK positive mutations/fusions), TNBC, SCCHN, MSI-Hi tumors, Hi TMB or mismatch repair deficient, gastric, cervical, endometrial, cutaneous squamous, small cell lung, esophageal, and HCC
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 For Phase 2, the following solid tumors are allowed: Melanoma, RCC, TNBC, NSCLC, SCCHN, and MSI-Hi tumors
Has at least 1 measurable lesion per RECIST 1.1 criteria which has not been biopsied or received prior irradiation
Has an accessible tumor for biopsy pre- and on-treatment (mandatory).

Exclusion Criteria

History of another malignancy
Known symptomatic brain metastases requiring \>10 mg/day of prednisolone or equivalent
Significant cardiovascular disease (MI, thrombotic events,) within 6 months prior to study treatmentSignificant ECG abnormalities (Phase 1a and 2 monotherapy only) including unstable cardiac arrhythmia requiring medication, second-degree atrioventricular block type II, third degree AV
Any degree of respiratory compromise (from either malignant or non-malignant disease)
Evidence of an ongoing systemic bacterial, fungal, or viral infection
Has received a live vaccine within 30 days
Major surgery within 4 weeks
Prior solid organ or bone marrow progenitor cell transplantation
Prior high dose chemotherapy requiring stem cell rescue
History of active autoimmune disorders
Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids.
Treatment with an approved, systemic anticancer therapy or an investigational agent within 4 weeks of Day 1
A positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral test within 28 days prior to dosing, unless there is Investigator-confirmed clinical recovery on or before C1D1
Subjects with adrenal insufficiency
Subjects with any chemistry or hematology laboratory values that are ≥Grade 2 Additional exclusion criteria for Phase 1 combination therapy only:
Presence of known active CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging, clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
Prior radiotherapy within 2 weeks of start of study treatment or history of radiation pneumonitis.
Presence of an active documented autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine or insulin) is not considered a form of systemic treatment and is allowed. Subjects may use topical and/or inhaled corticosteroids. However, subjects with adrenal insufficiency on replacement doses of steroids are not allowed.
Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX40, CD137), and was discontinued from that treatment due to a Grade 3 or higher irAE
Severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients. Subjects who have been retreated after such a reaction may be allowed after discussion with the Simcha Medical Monitor
History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Subjects that have received radiation therapy to the lung that is \>30Gy within 6 months of the first dose of study treatment

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Tampa?

Yes, this clinical trial (NCT04787042) has an active research site in Tampa, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

I cannot determine the primary medical condition from the provided information. The study title only mentions "ST-067" (which appears to be an investigational drug), and the conditions listed contain only drug/treatment names (ST-067, Obinutuzumab, and pembrolizumab) rather than medical conditions. The brief summary field appears to be incomplete. Without information about the actual disease or condition being treated, I cannot extract a patient-facing medical condition. Treatment Options in Tampa, FL

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