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New treatment option for Advanced Solid Tumor
Official title Phase 1/2 Study of Intratumoral Injection of STX-001 in Advanced Solid Tumors as Monotherapy or in Combination With Pembrolizumab
ClinicalTrials.gov ID: NCT06249048
What this study is testing
What is STX-001?
STX-001 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- General
- ≥ 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.
You likely can't join if
- History of primary immune deficiency.
- History of autoimmune disease and/or requiring immunosuppression (except hypothyroidism).
- History of History of Grade 3 or higher immune-related adverse events. Patient may be enrolled with Medical Monitor approval.
- History of solid organ transplant and taking immunosuppressive medications.
- Cardiovascular exclusions: Medical history of an arterial thrombotic event, stroke, or transient ischemic attack within the past 12 months; medical...
- Prior direct radiation therapy to the tumor lesion to be injected.
See the full eligibility criteria
Who can join
- General
- ≥ 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/International Normalized Ratio (PT/INR) or prothrombin time must be \< 1.5 × ULN;
- Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN unless undergoing anticoagulation therapy.
- Laboratory values (Liver): Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2 × ULN; Bilirubin ≤ 2 × ULN or ≤ 5 × ULN for all patients. Phase 1
- Histologically or cytologically documented, locally advanced, or metastatic solid tumor.
- Disease progression confirmed by imaging or other objective evidence after having received standard treatment or patients with refractory solid tumors. Patients must have progressed or are intolerant of at least one...
- Histologically or cytologically documented findings consistent with TNBC not amenable to curative surgery, radiation, or other therapy.
- Prior treatment (for advanced, metastatic or [neo]adjuvant) should have included a taxane and/or anthracycline-based therapy and, where appropriate, an approved checkpoint inhibitor.
- Has disease other than the injected lesion that is measurable by RECIST 1.1. Phase 2 (melanoma):
- Histologically or cytologically documented findings consistent with advanced melanoma not amenable to curative surgery, radiation, or other therapy. Uveal melanoma is excluded.
- Patients who are not candidates for or have refused available therapies are also eligible.
- Received an anti-programmed death-1 (PD-1) / programmed death ligand-1 (PD-L1) inhibitor as monotherapy or in combination with anti-cytotoxic lymphocyte associated protein 4 (CTLA-4) inhibitor and have either primary or...
- Has disease other than the injected lesion that is measurable by RECIST 1.1. Phase 1 and 2
What rules you out
- History of primary immune deficiency.
- History of autoimmune disease and/or requiring immunosuppression (except hypothyroidism).
- History of History of Grade 3 or higher immune-related adverse events. Patient may be enrolled with Medical Monitor approval.
- History of solid organ transplant and taking immunosuppressive medications.
- Cardiovascular exclusions: Medical history of an arterial thrombotic event, stroke, or transient ischemic attack within the past 12 months; medical history of symptomatic congestive heart failure (New York Heart...
- Prior direct radiation therapy to the tumor lesion to be injected.
- Active use of systemic anticoagulants
- Evidence of active infection requiring intravenous (IV) antibiotics during screening requiring therapy within 7 days prior to Cycle 1 Day 1.
- Active uncontrolled bleeding, or a bleeding diathesis within 7 days prior to Cycle 1 Day 1.
- Serious or non-healing wound, fistula, skin ulcer, or non-healing bone fracture within 7 days prior to Cycle 1 Day 1.
- Known human immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.
- Virology evaluation should be conducted at screening to include serum HIV antibody, HBc antibody, HBsAg antigen, and HCV antibody. Patients with a positive antibody evaluation for HCV and/or HBc should undergo...
- Untreated central nervous system tumor, epidural tumor or metastasis, or brain metastasis. Patients with any primary Central Nervous System (CNS) malignancy including glioma and current, active, progressing CNS...
- Patients with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (magnetic resonance...
- Another primary malignancy that has not been treated with curative intent, except for non-metastatic cutaneous basal cell or squamous cell carcinoma, or non-muscle invasive bladder cancer.
- Serious illness considered by the Investigator as incompatible with participating in this clinical study.
- Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of the patient's safety or study results.
- Prior IL-12 therapy.
- Receipt of any vaccine within 30 days prior to the first dose of study treatment.
- Use of another anticancer therapy within 3 weeks prior to Cycle 1 Day 1 or 5 half-lives, whichever is shorter.
- Previously enrolled in this study.
- Actively enrolled in another clinical study unless it is an observational (noninterventional) clinical study or the follow-up component of an treatment study.
- Known severe hypersensitivity (Grade ≥ 3) to study treatment or any of the excipients of the products.
- Known psychiatric or substance use disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
- Currently pregnant (confirmed with positive pregnancy test), breast-feeding or planning to become pregnant within 60 days following treatment. For women of childbearing potential (WOCBP), a negative serum beta-human...
- Women of childbearing potential not willing to use a highly effective method of contraception.
- Unwilling or unable to follow protocol requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Beverly Hills, California, United States
- Cleveland, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Wollstonecraft, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Beverly Hills, California, United States; Cleveland, Ohio, United States; Pittsburgh, Pennsylvania, United States; Houston, Texas, United States; Salt Lake City, Utah, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.