Actively Recruiting
Phase 1/2 Study of Intratumoral Injection of STX-001 in Advanced Solid Tumors as Monotherapy or in Combination With Pembrolizumab
Led by Strand Therapeutics Inc. · Updated on 2025-10-29
108
Participants Needed
7
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 1/2 Study of Intratumoral Injection of STX-001 in Advanced Solid Tumors as Monotherapy or in Combination With Pembrolizumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at screening
- Mentally competent and able to provide informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy of at least 12 weeks
- Body weight at least 40 kg
- At least 4 weeks since major surgery
- Willing and able to provide blood samples
- Has a tumor lesion suitable for injection and biopsy and consents to biopsy if safe
- Hematology labs: neutrophils ≥ 1,000 cells/mm3, platelets ≥ 75,000 cells/mm3, hemoglobin ≥ 8.0 g/dL
- Renal labs: serum creatinine < 1.5 times upper limit of normal or creatinine clearance ≥ 40 mL/min
- Coagulation labs: PT/INR or prothrombin time < 1.5 times upper limit of normal; aPTT ≤ 1.5 times upper limit unless on anticoagulation
- Liver labs: AST and ALT < 2 times upper limit of normal; bilirubin ≤ 2 times upper limit (or ≤ 5 times upper limit for all patients)
- Histologically or cytologically confirmed advanced or metastatic solid tumor with disease progression or intolerance to prior therapy for Phase 1
- For Phase 2 TNBC cohort: confirmed triple-negative breast cancer not suitable for curative treatment, prior taxane or anthracycline therapy, measurable disease beyond injected lesion
- For Phase 2 melanoma cohort: confirmed advanced melanoma (excluding uveal melanoma) not suitable for curative treatment, prior checkpoint inhibitor therapy with resistance or intolerance, measurable disease beyond injected lesion
You will not qualify if you...
- History of primary immune deficiency
- History of autoimmune disease requiring immunosuppression (except hypothyroidism)
- History of Grade 3 or higher immune-related adverse events without Medical Monitor approval
- History of solid organ transplant on immunosuppressive medications
- Cardiovascular events within past 12 months: arterial thrombosis, stroke, transient ischemic attack
- Symptomatic congestive heart failure (NYHA II-IV) or cardiac arrhythmia requiring treatment within past 12 months
- Myocardial infarction or unstable angina within 6 months before Cycle 1 Day 1
- QTcF prolongation > 470 ms in women and > 450 ms in men
- Prior radiation therapy to injected tumor lesion
- Active use of systemic anticoagulants
- Active infection requiring intravenous antibiotics within 7 days before Cycle 1 Day 1
- Active uncontrolled bleeding or bleeding disorder within 7 days before Cycle 1 Day 1
- Serious or non-healing wound, fistula, skin ulcer, or bone fracture within 7 days before Cycle 1 Day 1
- Known HIV, active hepatitis B or C infection
- Untreated central nervous system tumor or brain metastasis, except treated stable brain metastases with no progression for at least 4 weeks off steroids
- Other untreated primary malignancy except certain non-metastatic skin or bladder cancers
- Serious illness or condition interfering with study participation or evaluation
- Prior IL-12 therapy
- Receipt of any vaccine within 30 days before first dose
- Use of other anticancer therapy within 3 weeks or 5 half-lives before Cycle 1 Day 1
- Previously enrolled in this study
- Actively enrolled in another interventional clinical study
- Known severe hypersensitivity (Grade ≥ 3) to study treatments or excipients
- Psychiatric or substance use disorder interfering with study compliance
- Pregnant, breastfeeding, or planning pregnancy within 60 days after treatment
- Women of childbearing potential unwilling to use effective contraception
- Unwilling or unable to follow protocol requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
HonorHealth Research and Innovation Institute
Scottsdale, Arizona, United States, 85258
Not Yet Recruiting
2
NextGen Oncology
Beverly Hills, California, United States, 90212
Actively Recruiting
3
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
4
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
5
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
6
Huntsman Cancer Institute - University of Utah
Salt Lake City, Utah, United States, 84112
Not Yet Recruiting
7
Melanoma Institute Australia
Wollstonecraft, Australia
Actively Recruiting
Research Team
S
S Thomas, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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