RecruitingPhase 1Phase 2NCT06249048

Phase 1/2 Study of Intratumoral Injection of STX-001 in Advanced Solid Tumors as Monotherapy or in Combination With Pembrolizumab

A Phase 1/2, Open-label, Multi-center, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of STX-001 Delivered by Intratumoral Injection in Patients With Advanced Solid Tumors as a Monotherapy or in Combination With Pembrolizumab


Sponsor

Strand Therapeutics Inc.

Enrollment

108 participants

Start Date

May 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Phase 1/2, Open-label, Multi-center, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of STX-001 Delivered by Intratumoral Injection in Patients with Advanced Solid Tumors as a Monotherapy or in Combination with Pembrolizumab. The study now includes a monotherapy cohort targeting visceral lesions and a separate Phase 2 monotherapy cohort for advanced melanoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study tests a new drug called STX-001 injected directly into tumors, either alone or combined with an immunotherapy drug called pembrolizumab. STX-001 is designed to activate the immune system inside the tumor to fight the cancer. This is for people with advanced solid tumors. **You may be eligible if...** - You are 18 or older and weigh more than 40 kg - You have an advanced solid tumor that is accessible for injection and biopsy - Your cancer has not responded to standard treatment or no standard treatment is available - You are in good overall condition - Your blood counts and organ function meet required levels **You may NOT be eligible if...** - Your tumor cannot be safely injected or biopsied - You have active autoimmune disease - You have had major surgery in the past 4 weeks - You are pregnant or breastfeeding - You have active uncontrolled infection or significant heart disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALSTX-001

STX-001 encapsulates a self-replicating RNA encoded for IL-12, contained within an LNP for intratumoral injection. Injections may be administered into multiple lesions according to protocol-defined procedures.

BIOLOGICALKeytruda®

Pembrolizumab (Keytruda USPI 2023) is a marketed PD-1 blocking humanized monoclonal IgG4 kappa antibody.


Locations(7)

HonorHealth Research and Innovation Institute

Scottsdale, Arizona, United States

NextGen Oncology

Beverly Hills, California, United States

Cleveland Clinic

Cleveland, Ohio, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Huntsman Cancer Institute - University of Utah

Salt Lake City, Utah, United States

Melanoma Institute Australia

Wollstonecraft, Australia

View Full Details on ClinicalTrials.gov

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NCT06249048


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