Status and phase
Conditions
Treatments
About
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
Full description
This open-label, Phase 1/2, first-in-human (FIH), multiple ascending dose and dose expansion study involves STX-001 administration, alone or in combination with pembrolizumab, to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity in patients with advanced cancers.
Phase 1 consists of 4 planned dose escalation cohorts of STX-001 delivered as a monotherapy (Cohorts 1m), and 4 planned dose escalation cohorts of STX-001 delivered as a combination therapy, with pembrolizumab treatment given concurrently (Cohorts 1c). New patients will be enrolled in each dose escalation cohort.
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) will be selected based on analysis of the totality of data from Phase 1.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
General Inclusion Criteria:
Phase 1 Inclusion Criteria:
Phase 2 Inclusion Criteria (TNBC):
Phase 2 Inclusion Criteria (melanoma):
Phase 1 and 2 Exclusion Criteria:
Recent medical concerns exclusions:
Primary purpose
Allocation
Interventional model
Masking
108 participants in 3 patient groups
Loading...
Central trial contact
Tasuku Kitada, PhD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal