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NCT04787042RECRUITINGIRB Ready

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

Sponsored by Simcha IL-18, Inc.

Quick Self-Assessment

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Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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 \[Gazyvaยฎ\] 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.

Who Can Participate

Inclusion Criteria

Male and female patients aged โ‰ฅ18 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

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

316 participants

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Gender

ALL

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Sponsor

Simcha IL-18, Inc.

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Scottsdale

Arizona

Location available
View Scottsdale location page
RECRUITING

Denver

Colorado

Location available
View Denver location page
RECRUITING

New Haven

Connecticut

Location available
View New Haven location page
RECRUITING

Tampa

Florida

Location available
View Tampa location page
RECRUITING

Boston

Massachusetts

Location available
View Boston location page
RECRUITING

Buffalo

New York

Location available
View Buffalo location page

Frequently Asked Questions

Q: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.

Q: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.

Q: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.

Q: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.

Q: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.

Q: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.

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

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for 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 in Scottsdale?

Join others in Arizona exploring innovative treatment options through clinical research

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 Scottsdale, Arizona

If you're searching for 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 in Scottsdale, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Scottsdale, Denver, New Haven and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with 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.. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Arizona
Now Enrolling
Up to 316 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for 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.?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for 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.

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions 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

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT04787042. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.