OncoMatch/Clinical Trials/NCT07751042
Phase 1/2 Study of Intravenous Injection of STX-003 in Advanced Solid Tumors as Monotherapy or in Combination With Pembrolizumab
Is NCT07751042 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies multiple treatments including STX-003 and KEYTRUDA® for advanced solid tumor.
Treatment: STX-003 · KEYTRUDA® — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Tumor Agnostic
Non-Small Cell Lung Carcinoma
Melanoma
Biomarker criteria
Required: PD-L1 (CD274) expression (positive)
Biomarker confirmed as PD-L1+ per local institutional standard practice.
Required: BRAF v600e
Patients with BRAF V600E mutant melanoma should have received a BRAF inhibitor as monotherapy or in combination with other targeted agents (MAPK kinase MEK inhibitors), unless deemed intolerable by the Investigator.
Excluded: EGFR activating mutation
Patients with known activating EGFR, STK11 or KEAP1 mutations as well as ALK/ROS1 fusions, are not eligible.
Excluded: STK11 activating mutation
Patients with known activating EGFR, STK11 or KEAP1 mutations as well as ALK/ROS1 fusions, are not eligible.
Excluded: KEAP1 activating mutation
Patients with known activating EGFR, STK11 or KEAP1 mutations as well as ALK/ROS1 fusions, are not eligible.
Excluded: ALK fusion
Patients with known activating EGFR, STK11 or KEAP1 mutations as well as ALK/ROS1 fusions, are not eligible.
Excluded: ROS1 fusion
Patients with known activating EGFR, STK11 or KEAP1 mutations as well as ALK/ROS1 fusions, are not eligible.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy — advanced/metastatic or [neo]adjuvant NSCLC
Prior treatment (for advanced, metastatic or [neo]adjuvant) should have included a platinum-based therapy and a PD-1/L1 pathway checkpoint inhibitor, unless the patient is not a candidate for or has refused viable therapies due to inability to tolerate treatment (i.e. cell therapy) or potential side effects (i.e. checkpoint inhibitor toxicity).
Must have received: anti-PD-1 therapy — advanced/metastatic or [neo]adjuvant NSCLC
Prior treatment (for advanced, metastatic or [neo]adjuvant) should have included a platinum-based therapy and a PD-1/L1 pathway checkpoint inhibitor, unless the patient is not a candidate for or has refused viable therapies due to inability to tolerate treatment (i.e. cell therapy) or potential side effects (i.e. checkpoint inhibitor toxicity).
Must have received: anti-PD-L1 therapy — advanced/metastatic or [neo]adjuvant NSCLC
Prior treatment (for advanced, metastatic or [neo]adjuvant) should have included a platinum-based therapy and a PD-1/L1 pathway checkpoint inhibitor, unless the patient is not a candidate for or has refused viable therapies due to inability to tolerate treatment (i.e. cell therapy) or potential side effects (i.e. checkpoint inhibitor toxicity).
Must have received: anti-PD-1 therapy — advanced cutaneous melanoma
Received an anti-PD-1/PD-L1 inhibitor as monotherapy or in combination with anti-CTLA-4 inhibitor and have either primary or secondary checkpoint inhibitor resistance asper SITC consensus definition, unless deemed intolerable by the Investigator.
Must have received: anti-PD-L1 therapy — advanced cutaneous melanoma
Received an anti-PD-1/PD-L1 inhibitor as monotherapy or in combination with anti-CTLA-4 inhibitor and have either primary or secondary checkpoint inhibitor resistance asper SITC consensus definition, unless deemed intolerable by the Investigator.
Must have received: anti-CTLA-4 therapy — advanced cutaneous melanoma
Received an anti-PD-1/PD-L1 inhibitor as monotherapy or in combination with anti-CTLA-4 inhibitor and have either primary or secondary checkpoint inhibitor resistance asper SITC consensus definition, unless deemed intolerable by the Investigator.
Must have received: BRAF inhibitor — advanced cutaneous melanoma
Patients with BRAF V600E mutant melanoma should have received a BRAF inhibitor as monotherapy or in combination with other targeted agents (MAPK kinase MEK inhibitors), unless deemed intolerable by the Investigator.
Must have received: MEK inhibitor — advanced cutaneous melanoma
Patients with BRAF V600E mutant melanoma should have received a BRAF inhibitor as monotherapy or in combination with other targeted agents (MAPK kinase MEK inhibitors), unless deemed intolerable by the Investigator.
Cannot have received: STX-003 or other VEEV-based replicating RNA
Prior treatment with STX-003 or other VEEV-based replicating RNA.
Cannot have received: IL-12 therapy
Prior IL-12 therapy.
Lab requirements
Blood counts
ANC ≥ 1,000 cells/mm3. Platelet count ≥ 75,000 cells/mm3. Hemoglobin ≥ 8.0 g/dL.
Kidney function
Serum creatinine < 1.5 × ULN or creatinine clearance ≥ 40 mL/min based on the Cockcroft-Gault glomerular filtration rate estimation
Liver function
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.
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. 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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- HonorHealth Research Institute · Scottsdale, Arizona
- Sarah Cannon Research Institute · Nashville, Tennessee
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07751042 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior STX-003 or other VEEV-based replicating RNA, IL-12 therapy disqualifies patients from enrollment.
Does this trial require CD274?
Yes, CD274 expression is a required biomarker for enrollment.
Does this trial require BRAF?
Yes, BRAF v600e is a required biomarker for enrollment.
Are patients with EGFR alterations eligible?
No. EGFR activating mutation is an exclusion criterion.
Are patients with STK11 alterations eligible?
No. STK11 activating mutation is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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