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

NCT07751042 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2026-08-06

No results posted yet for this study

Summary

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.

Conditions

  • Advanced Solid Tumor

Interventions

BIOLOGICAL

STX-003

STX-003 is a LNP formulated self-replicating mRNA encoding the therapeutic payload human IL-12 (hIL-12) with miRNA target sites to sense specific endogenous miRs.

BIOLOGICAL

KEYTRUDA®

Pembrolizumab (Keytruda USPI 2026) is a marketed PD-1 blocking humanized monoclonal IgG4 kappa antibody.

Sponsors & Collaborators

  • Strand Therapeutics Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2030-07-17
Completion
2030-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07751042 on ClinicalTrials.gov