Spots Global Cancer Trial Database for Study of IT STX-001 in Patients With Advanced Solid Tumors as Monotherapy or in Combination With Pembrolizumab

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Trial Identification

Brief Title: Study of IT STX-001 in Patients With Advanced Solid Tumors as Monotherapy or in Combination With Pembrolizumab

Official Title: Ph 1/2 Open-label, Multi-center, FIH Study of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics & Antitumor Activity of STX-001 Via Intratumoral Injection in Pts w Advanced Solid Tumors as Monotherapy or Combination w Pembrolizumab

Study ID: NCT06249048

Conditions

Advanced Solid Tumor

Interventions

STX-001

Keytruda®

Study Description

Brief Summary: 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

Detailed 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.