Phase 1/2 Study of Intratumoral Injection of STX-001 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
NCT06249048
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-001 — BIOLOGICAL
    STX-001 encapsulates a self-replicating RNA encoded for IL-12, contained within an LNP for intratumoral injection. Injections may be administered into multiple lesions according to protocol-defined procedures.
  • Keytruda® — BIOLOGICAL
    Pembrolizumab (Keytruda USPI 2023) 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-001 Delivered by Intratumoral Injection in Patients with Advanced Solid Tumors as a Monotherapy or in Combination with Pembrolizumab. The study now includes a monotherapy cohort targeting visceral lesions and a separate Phase 2 monotherapy cohort for advanced melanoma.

Key Dates

Start date
May 3, 2024
Status verified
Oct 2025
Primary completion
May 31, 2027
Completion
Nov 30, 2028

Study Design

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

Arms

  • Experimental: Phase 1 Monotherapy (STX-001)
    A Phase 1, first-in-human (FIH), multiple ascending dose administration of intratumoral STX-001 monotherapy to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary antitumor activity in patients with advanced cancers. Consists of four planned dose-escalation cohorts (Cohorts 1m) plus permitted backfill enrollment (up to 30 patients). New patients are enrolled in each dose escalation cohort, and dose escalation may be stopped early if emerging PK or safety data warrant it. Dose extension and treatment pauses are integrated, with a maximum extension of 35 cycles (≈24 months).
  • Experimental: Phase 1 Combination (STX-001 with Pembrolizumab)
    A Phase 1, first-in-human (FIH), multiple ascending STX-001 dose administration, in combination with pembrolizumab, to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity in patients with advanced cancers. Consists of 4 planned dose escalation cohorts (Cohorts 1c) of STX-001and pembrolizumab given concurrently, with new patients enrolled in each dose escalation cohort. Dose escalation may be halted early if PK or safety data indicate, and the dose extension period extends up to 35 cycles with treatment pauses. Backfill enrollment is permitted up to 30 patients.
  • Experimental: Phase 2 Combination (STX-001 with Pembrolizumab)
    Phase 2 consists of dose expansion cohorts in patients with 2 defined cancer types: triple negative breast cancer (TNBC) and melanoma. Phase 2 will evaluate STX-001 in combination with pembrolizumab; the recommended Phase 2 dose (RP2D) of STX-001 will be selected based on analysis of the totality of data from Phase 1 safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy data. Dose extension and treatment pauses are incorporated.
  • Experimental: Phase 1 Visceral-lesion Monotherapy (Cohort 1Vm)
    Phase 1, first-in-human (FIH) monotherapy cohort targeting visceral lesions. STX-001 is administered intratumorally at 30 µg, 100 µg and 300 µg to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity in patients with advanced cancers. Cohort 1Vm is part of the dose escalation stage; new patients are enrolled at each dose level, and backfill enrollment is permitted up to 30 patients. Dose escalation may be stopped early if PK or safety data warrant it.
  • Experimental: Phase 2 Advanced-Melanoma Monotherapy
    Phase 2 dose expansion cohort evaluating STX-001 monotherapy administered intratumorally to patients with advanced melanoma. Assesses safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity with the recommended dose selected based on Phase 1 data. Dose extension and treatment pauses are allowed up to 35 cycles.

Primary Outcome Measure

Number and nature of dose-limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) in patients with advanced solid tumors. [ Time Frame: From time of informed consent until 30 days after the last dose of investigational product (STX-001). ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
HonorHealth Research and Innovation InstituteScottsdaleArizona85258
Amy Stolldastice
[email protected]
602-570-2383
NextGen OncologyBeverly HillsCalifornia90212
Mini Gill
[email protected]
424-777-0708
Cleveland ClinicClevelandOhio44195
Heather Keaney
[email protected]
216-559-9815
University of Pittsburgh Medical CenterPittsburghPennsylvania15232
Julie Urban
[email protected]
412-623-7396
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Rabia Khan
[email protected]
713-563-4667
Huntsman Cancer Institute - University of UtahSalt Lake CityUtah84112
Shantae George
[email protected]
801-213-8486

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HonorHealth Research and Innovation Institute· Scottsdale, AZNextGen Oncology· Beverly Hills, CACleveland Clinic· Cleveland, OHUniversity of Pittsburgh Medical Center· Pittsburgh, PAThe University of Texas MD Anderson Cancer Center· Houston, TXHuntsman Cancer Institute - University of Utah· Salt Lake City, UT

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