Phase 1/2 Study of Intravenous Injection of STX-003 in Advanced Solid Tumors as Monotherapy or in Combination With Pembrolizumab

Recruiting now · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumor

In brief

Phase 1/2, Open-label, Multi-center, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of STX-003 Delivered by Intravenous Injection in Patients with Advanced Solid Tumors as a Monotherapy or in Combination with Pembrolizumab.

Key facts

Study ID

NCT07751042

Run by

Strand Therapeutics Inc.

People needed

220

Starts

2026-06-30

Expected to finish

2030-11-15

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion Criteria (Phase 1 and Phase 2)
• Mentally competent and able to understand and sign the ICF.
• Tumor type for which there is an FDA-approved anti-PD-1/L1 antibody therapy, specifically including biomarker labeled subsets (i.e. PD-L1+) as well as anatomical subsets in some disease (cutaneous melanoma is eligible whereas acral, mucosal and uveal are not; Phase 1) and advanced cutaneous melanoma or PD-L1+ NSCLC.
• Histologically or cytologically documented, locally advanced, or metastatic solid tumor.
• At least one measurable lesion per RECIST v1.1 criteria.
• The patient lacks a curative therapy or has progressive disease despite, or refused, standard therapy.
• ECOG performance status of 0 or 1.
• Life expectancy of ≥ 12 weeks per the Investigator.
• ≥ 18 years of age at the time of informed consent.
• Body weight ≥ 40 kg.
• WOCBP and males with female partners of child-bearing potential must agree to use adequate birth control throughout their participation and for 3 months following the last dose of STX-003.
• Willing and able to comply with protocol required assessments.
• Hematology:
• ANC ≥ 1,000 cells/mm3.
• Platelet count ≥ 75,000 cells/mm3.
• Hemoglobin ≥ 8.0 g/dL.
• Renal: Serum creatinine < 1.5 × ULN or creatinine clearance ≥ 40 mL/min based on the Cockcroft-Gault glomerular filtration rate estimation
• Coagulation:
• PT/INR or PT must be ≤ 1.5 × ULN.
• aPTT ≤ 1.5 × ULN unless undergoing anticoagulation therapy.
• Liver:
• Albumin ≥ 3.5 g/dL or within the normal range of the local reference laboratory.
• AST and ALT < 2 × ULN.
• Bilirubin ≤ 1.5 × ULN (except participants with documented Gilbert's syndrome who may be enrolled if the conjugated bilirubin is within normal limits) or ≤ 5 × ULN with liver metastases.
• Phase 2 Inclusion Criteria

You may not qualify if…

• Exclusion Criteria (Phase 1 and 2)
• Medical Conditions
• History of primary immune deficiency.
• History of clinically significant autoimmune disease that has required intervention in the last 6 months. Consultation with the MM may inform the discussion of whether autoimmune disease is clinically significant.
• History of Grade 3 or higher IRAEs that has not resolved to Grade ≤ 1 at the time of enrollment. Exceptions include endocrine disorders that are well-managed with stable physiological hormone replacement and Grade 3 immune-related rash. Patients meeting this criterion may be considered for enrollment following approval by the MM.
• 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 6 months.
• Medical history of symptomatic congestive heart failure (New York Heart Association classes II-IV) or a cardiac arrhythmia that required treatment within the past 6 months.
• Medical history of myocardial infarction or unstable angina within 6 months before C1D1.
• Recent medical concerns exclusions
• Evidence of active infection requiring IV antibiotics within 7 days prior to C1D1.
• Active uncontrolled bleeding, or a bleeding diathesis within 7 days prior to C1D1.
• Serious or non-healing wound, fistula, skin ulcer, or non-healing bone fracture within 7 days prior to C1D1.
• Known 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 evaluation to measure HCV RNA or HBV DNA, respectively.
• Untreated CNS tumor, epidural tumor or metastasis, or brain metastasis. Patients with any primary CNS malignancy including glioma and current, active, or progressing CNS malignancy, including carcinomatosis meningitis, are excluded.
• 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 (MRI or CT scan) during the Screening period and are off systemic steroids (for at least 2 weeks prior to first dose).
• Another primary malignancy that has not been treated with curative intent (discuss with MM), 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.
• Major surgery within 4 weeks of first dose of study drug.
• Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of the patients' safety or study results.
• Prior/Concomitant Therapy
• Prior treatment with STX-003 or other VEEV-based replicating RNA.
• Prior IL-12 therapy.

Where it is running

• HonorHealth Research Institute — Scottsdale, Arizona, United States (enrolling)
• Sarah Cannon Research Institute — Nashville, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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