ST-067-001 for Solid Tumors
Trial Summary
What is the purpose of this trial?
This trial is testing a new drug called ST-067 on patients with certain types of cancer that have not responded to previous treatments. The goal is to find the safest and most effective dose and to see how well it works against these cancers.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are on ongoing immunosuppressive therapy or have received systemic anticancer therapy within 4 weeks of starting the trial.
What data supports the effectiveness of the treatment ST-067, Decoy-Resistant IL-18, when used with immunotherapy for advanced cancers?
Research shows that a similar treatment using a combination of IL-12 and Decoy-Resistant IL-18 can enhance the body's immune response against tumors, especially when injected directly into the tumor. This combination helps activate specific immune cells that attack cancer cells, suggesting potential effectiveness for ST-067 in advanced cancers.12345
Is the combination of ST-067 (Decoy-Resistant IL-18) and immunotherapy safe for humans?
What makes the drug ST-067 unique for treating advanced cancers?
ST-067, also known as Decoy-Resistant IL-18, is unique because it is engineered to resist inhibition by IL-18BP, a decoy receptor that limits the effectiveness of traditional IL-18 therapies. This allows ST-067 to enhance the immune system's ability to fight tumors by promoting the activity of specific immune cells, such as CD8+ T cells and natural killer cells, which are crucial for attacking cancer cells.356910
Research Team
Jeremy Barton, MD
Principal Investigator
Simcha IL-18, Inc.
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase 1a Dose Escalation
Determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of ST-067, administered by subcutaneous (SC) or intravenous (IV) dosing, with or without obinutuzumab pre-treatment.
Phase 1 Combination Therapy
Dose escalation in combination with pembrolizumab to determine MTD using mTPI design.
Phase 2 Expansion
Evaluate the preliminary efficacy of ST-067 administered at the RP2D in various solid tumors using a Simon 2 stage design.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- ST-067 (Other)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Simcha IL-18, Inc.
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University