Phase 1/2 Study of Intravenous Injection of STX-003 in Advanced Solid Tumors as Monotherapy or in Combination With Pembrolizumab
Protocol Title: 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. Protocol Name: ASCENT-1: Activated, Selective, Controlled Expression of a Novel Programmable mRNA Therapeutic
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Checked against the public recordLast updated Oct 27, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Strand Therapeutics Inc.
- Interventions being studied
- Biological: STX-003; Biological: KEYTRUDA®
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Inclusion Criteria (Phase 1 and Phase 2) 1. Mentally competent and able to understand and sign the ICF. 2. 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. 3. Histologically or cytologically documented, locally advanced, or metastatic solid tumor. 4. At least one measurable lesion per RECIST v1.1 criteria. 5. The patient lacks a curative therapy or has progressive disease despite, or refused, standard therapy. 6. ECOG performance status of 0 or 1. 7. Life expectancy of ≥ 12 weeks per the Investigator. 8. ≥ 18 years of age at the time of informed consent. 9. Body weight ≥ 40 kg. 10. 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. 11. 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 13\. NSCLC :
- 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 therapies due to inability to tolerate treatment (i.e. cell therapy) or potential side effects (i.e. checkpoint inhibitor toxicity). 14\. Melanoma : Histologically or cytologically documented findings consistent with advanced cutaneous melanoma not amenable to curative surgery, radiation, or other therapy. Acral, mucosal and uveal melanoma are excluded.
- 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 intolerable by the Investigator. 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- HonorHealth Research InstituteScottsdale, Arizona
- Massachusetts General HospitalBoston, Massachusetts
- Sarah Cannon Research InstituteNashville, Tennessee
- Melanoma Institute AustraliaWollstonecraft, New South Wales
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 27, 2026. Always confirm current availability with the study team.