NCT06249048 · Strand Therapeutics Inc.
Phase 1/2 Study of Intratumoral Injection of STX-001 in Advanced Solid Tumors as Monotherapy or in Combination With Pembrolizumab
What this study is about
Phase 1/2, where both patients and doctors know the treatment given, Multi-center, First-in-human Study of the Safety, Tolerability, how the drug moves through the body, how the drug affects the body and Anti-tumor Activity of STX-001 Delivered by Intratumoral Injection in Patients with Advanced Solid Tumors as a treatment given alone or in Combination with Pembrolizumab
View original scientific description
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
Interventions
BIOLOGICAL
STX-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.
BIOLOGICAL
Keytruda®
Pembrolizumab (Keytruda USPI 2023) is a marketed PD-1 blocking humanized monoclonal IgG4 kappa antibody.
Primary outcome measures
Number and nature of dose-limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) in patients with advanced solid tumors.
Time frame: From time of informed consent until 30 days after the last dose of investigational product (STX-001).
The occurrence of DLTs, TEAEs, and SAEs will be used to determine the maximum tolerated dose and recommended Phase 2 dose of STX-001.
Occurrence of changes from baseline in patients' clinical safety laboratory values and vital signs to assess the safety and tolerability of STX-001.
Time frame: From time of informed consent until 30 days after the last dose of investigational product (STX-001).
Collection and analysis of changes in data from baseline of patients' vital signs (temperature, pulse, respiratory rate, blood pressure, oxygen saturation via pulse oximetry) as well as clinical safety laboratory values (chemistry, hematology, coagulation, complement (Bb \& C3a), urinalysis, and lipids).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- ≥ 18 years of age at the time of screening.
- Mentally competent and able to understand and sign the informed consent form (ICF).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of ≥ 12 weeks per the Investigator.
- Body weight ˃ 40 kg.
- At least 4 weeks from any prior major surgery.
- Willing and able to provide blood samples prior to the start of this study.
- Has a tumor lesion amenable to injection, must be accessible for pre and post injection biopsy, and the patient must be willing to consent to biopsy, if deemed safe by the Investigator.
- Laboratory values (Hematology): Absolute neutrophil count ≥ 1,000 cells/mm3; Platelet count ≥ 75,000 cells/mm3; Hemoglobin ≥ 8.0 g/dL.
- Laboratory values (Renal): Serum creatinine \< 1.5 × upper limit of normal (ULN) or creatinine clearance ≥ 40 mL/min based on the Cockcroft-Gault glomerular filtration rate estimation
- Laboratory values (Coagulation): Prothrombin/Int
Where
- Scottsdale, Arizona
- Beverly Hills, California
- Cleveland, Ohio
- Pittsburgh, Pennsylvania
- Houston, Texas
- Salt Lake City, Utah
Related conditions & keywords
Frequently asked questions
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.
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.
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.
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.
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.
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.
Data: ClinicalTrials.gov · synced Oct 29, 2025 · Source of record for eligibility and locations