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ST-067-001 for Solid Tumors

Verified Trial
Phase 1
Recruiting
Research Sponsored by Simcha IL-18, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Are you mobile and able to carry out light work throughout your day?
Have you been diagnosed with advanced or metastatic cancer (solid tumor) and received standard treatments?
Must not have
Have you been diagnosed with Hepatitis B, Hepatitis C, or HIV?
Have you received radiation therapy in the last two weeks or do you have radiation therapy planned?
Timeline
Screening 28 days
Treatment 24 months
Follow Up 30 days
Awards & highlights

Study Summary

This trial is testing a new cancer drug called ST-067. Phase 1a is testing how well the drug works and what the right dose is.

Who is the study for?
Adults (≥18 years) with advanced or metastatic cancer, including melanoma and lung cancer, who've progressed after standard therapy or for whom no survival-prolonging standard care is available. Participants must be able to perform light work (ECOG status of 0 or 1), have at least one measurable lesion not previously treated by biopsy or radiation, and an accessible tumor for required biopsies.Check my eligibility
What is being tested?
The trial tests ST-067 as a subcutaneous injection alone and in combination with IV infusion obinutuzumab (Gazyva®) plus pembrolizumab (Keytruda). It's a multi-phase study starting with dose escalation to assess safety and preliminary effectiveness before moving on to Phase 2.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site for ST-067, infusion-related reactions from obinutuzumab, and immune system-related adverse effects such as fatigue, skin issues, digestive disturbances from pembrolizumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can move around and do light tasks throughout the day.
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I have advanced cancer and have undergone standard treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with Hepatitis B, C, or HIV.
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I have not had radiation therapy in the last two weeks and do not have any planned.
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I do not have serious heart, breathing, adrenal gland, or autoimmune conditions.

Timeline

Screening ~ 28 days
Treatment ~ 24 months
Follow Up ~30 days
This trial's timeline: 28 days for screening, 24 months for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the maximum tolerated dose and recommended Phase 2 doese of ST-067 in phase 1a monotherapy
Evaluate the overall safety and tolerability of ST-067 in combination with pembrolizumab (Keytruda)
Number of Participants With Treatment-Related Adverse Events
+1 more
Secondary outcome measures
To characterize the PK and PD profiles of ST-067 with pembrolizumab (Keytruda)
To characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of ST-067 as a single agent
To evaluate the antitumor activity of ST-067 and ST-067 in combination with pembrolizumab (Keytruda)
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: ST-067 subcutaneous + pembrolizumab (Keytruda)Experimental Treatment2 Interventions
The Phase 1 Combination therapy is an open-label dose escalation study of ST-067 in combination with pembrolizumab (Keytruda) in subjects with solid tumors experiencing insufficient response to a checkpoint inhibitor (PD-1) therapy.The Phase 1 combination cohort will not open until the tolerability of a given ST-067 dose level has been confirmed safe in the monotherapy arm.
Group II: ST-067 subcutaneous + obinutuzumab (Gazyva) pre-treatmentExperimental Treatment2 Interventions
The starting dose for ST-067 with obinutuzumab (Gazyva) pre-treatment will be 120µg/kg. Obinutuzumab (Gazyva) will be administered at 1000 mg daily via IV infusion on 2 consecutive days, with the first dose given at least 7 days prior to first dose of SC ST-067.
Group III: ST-067 IV infusion monotherapyExperimental Treatment1 Intervention
The starting dose for the IV monotherapy dosing will be a dose that is modeled to have a maximum concentration observed that does not exceed the highest tolerated SC dose approved by the ISRC. ST-067 will be given on a weekly schedule when administered by the IV route of administration. Escalation decisions for the IV formulation will be based primarily on its emerging toxicity profile.

Find a Location

Who is running the clinical trial?

Simcha IL-18, Inc.Lead Sponsor

Media Library

ST-067 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04787042 — Phase 1
Squamous Cell Carcinoma Clinical Trial 2023: ST-067 Highlights & Side Effects. Trial Name: NCT04787042 — Phase 1
ST-067 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04787042 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research project currently welcoming new participants?

"In accordance with the clinicaltrials.gov database, this research is presently recruiting participants; it was first made accessible on August 6th 2021 and underwent its latest update July 30th 2023."

Answered by AI

Am I a viable candidate for this medical experiment?

"To be accepted into this medical experiment, prospects must have a solid tumor and fall in the age range of 18 to 9007199254740991. The researchers are recruiting a total of 316 individuals for their study."

Answered by AI

Who else is applying?

What site did they apply to?
Roswell Park Cancer Institute
Moffitt Cancer Center
Yale Cancer Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Typically responds via
Email
Phone Call
Average response time
  • < 2 Days
Most responsive sites:
  1. HonorHealth Research Institute: < 24 hours
  2. Providence Cancer Institute Franz Clinic: < 24 hours
  3. Roswell Park Cancer Institute: < 48 hours
Recent research and studies
clinicaltrials.govStudy
Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067
2021. "Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04787042.
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