Advanced Solid Tumor study: STX-003 vs KEYTRUDA®
Official title Phase 1/2 Study of Intravenous Injection of STX-003 in Advanced Solid Tumors as Monotherapy or in Combination With Pembrolizumab
ClinicalTrials.gov ID: NCT07751042
What this study is testing
What is STX-003?
STX-003 is an investigational medicine, given as an IV infusion (through a vein), 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
- This study is testing whether STX-003 given by IV is safe and how it works, either by itself or together with pembrolizumab, in people with advanced solid tumors.
- Who it's for
- You may be able to join if you have an advanced solid tumor that cannot be cured with standard treatments.
- What's involved
- You would receive an IV infusion of STX-003, and some may also get an IV infusion of pembrolizumab. You will have regular doctor visits, blood tests, and scans to check how your body responds.
- Time commitment
- The study lasts several months and requires visits to the clinic for infusions and check‑ups about every few weeks.
- 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
- (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.
- Histologically or cytologically documented, locally advanced, or metastatic solid tumor.
- At least one measurable lesion per RECIST v1.1 criteria.
You likely can't join 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.
- History of Grade 3 or higher IRAEs that has not resolved to Grade ≤ 1 at the time of enrollment.
- History of solid organ transplant and taking immunosuppressive medications.
See the full eligibility criteria
Who can join
- (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.
- 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.
- ANC ≥ 1,000 cells/mm3.
- Platelet count ≥ 75,000 cells/mm3.
- Hemoglobin ≥ 8.0 g/dL.
- PT/INR or PT must be ≤ 1.5 × ULN.
- aPTT ≤ 1.5 × ULN unless undergoing anticoagulation therapy.
- Albumin ≥ 3.5 g/dL or within the normal range of the local reference laboratory.
- AST and ALT \< 2 × ULN.
- Histologically or cytologically documented findings consistent with NSCLC not amenable to curative surgery, radiation, or other therapy.
- Biomarker confirmed as PD-L1+ per local institutional standard practice.
- Patients with known activating EGFR, STK11 or KEAP1 mutations as well as ALK/ROS1 fusions, are not eligible.
- 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...
- Patients who are not candidates for or have refused available therapies due to inability to tolerate treatment (i.e. cell therapy) or potential side effects (i.e. checkpoint inhibitor toxicity) are also eligible.
- 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...
What rules you out
- 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...
- 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.
- Virology evaluation should be conducted at Screening to include serum HIV antibody, HBc antibody, HBsAg antigen, and HCV antibody.
- 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...
- 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)...
- 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. 4\. Prior/Concomitant Therapy
- Prior treatment with STX-003 or other VEEV-based replicating RNA.
- Prior IL-12 therapy.
- Receipt of any live vaccine within 30 days prior to the first dose of study treatment.
- Use of another systemic anticancer therapy within 3 weeks prior to C1D1 or 5 halflives, whichever is shorter or use of radiotherapy within 1 week prior to C1D1 5. Prior/Concurrent Clinical Study Experience
- 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. Other Exclusions
- History of interstitial lung disease or active, non-infectious pneumonitis (combination cohorts only).
- Known psychiatric or substance use disorder that would interfere with the patient's ability to cooperate with the requirements of the study.
- Currently pregnant (confirmed with a positive pregnancy test), breast-feeding or planning to become pregnant within 6 months following treatment.
The study team makes the final eligibility decision.
Where it is enrolling
- Scottsdale, Arizona, United States
- Boston, Massachusetts, United States
- Nashville, Tennessee, United States
- Wollstonecraft, New South Wales, 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, but 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?
This study is enrolling now at Scottsdale, Arizona, United States; Boston, Massachusetts, United States; Nashville, Tennessee, United States; Wollstonecraft, New South Wales, Australia. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.