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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Strand Therapeutics Inc.
Study ID
NCT07751042
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • STX-003 — BIOLOGICAL
    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.
  • KEYTRUDA® — BIOLOGICAL
    Pembrolizumab (Keytruda USPI 2026) is a marketed PD-1 blocking humanized monoclonal IgG4 kappa antibody.

Study Details

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 Dates

First listed
Aug 6, 2026
Start date
Jun 30, 2026
Status verified
Aug 2026
Primary completion
Jul 17, 2030
Completion
Nov 15, 2030

Study Design

Enrollment
220 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Monotherapy
    STX-003 administered intravenously, at ascending doses across sequential cohorts, once per cycle for up to 35 cycles (approximately 24 months).
  • Experimental: Phase 1 Combination (STX-003 with Pembrolizumab)
    STX-003 administered intravenously, at ascending doses across sequential cohorts, once per cycle in combination with pembrolizumab for up to 35 cycles (approximately 24 months).
  • Experimental: Phase 2 Monotherapy (STX-003)
    STX-003 administered intravenously, at 4 planned dose expansion cohorts in patients with advanced cancers with high unmet need, once per cycle for up to 35 cycles (approximately 24 months).
  • Experimental: Phase 2 Combination (STX-003 with Pembrolizumab)
    STX-003 administered intravenously, at 4 planned dose expansion cohorts in patients with advanced cancers with high unmet need, once per cycle for up to 35 cycles (approximately 24 months).

Primary Outcome Measure

Incidence of TEAEs, SAEs, and DLTs [ Time Frame: From time of informed consent until 30 days after the last dose of investigational product. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
HonorHealth Research InstituteScottsdaleArizona85258
Amy Stolldastice
[email protected]
602-570-2383
Justin Moser, MD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research InstituteNashvilleTennessee37203
Ashley Maheu
[email protected]
615-329-7274
Melissa Johnson, MD (PRINCIPAL_INVESTIGATOR)

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HonorHealth Research Institute· Scottsdale, AZSarah Cannon Research Institute· Nashville, TN

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