NCT06063681

A Study of SR-8541A (ENPPI Inhibitor) in Advanced/Metastatic Solid Tumors

Phase 1, Dose Escalation, Safety, Tolerability, and Pharmacokinetic Study of SR-8541A (ENPP1 Inhibitor) Administered Orally as Monotherapy or in Combination With Checkpoint Inhibitors in Subjects With Advanced/Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Stingray Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, dose-escalation, multi-center phase 1 study evaluating the safety, tolerability, and pharmacokinetics (PK) of SR-8541A administered orally as a monotherapy or in combination with an immune checkpoint inhibitor (ICI) in subjects with solid tumors.

Detailed description

SR-8541A, an ENPP1 inhibitor, will be administered orally as a monotherapy to assess safety, tolerability, and pharmacokinetics (PK) in subjects with advanced/metastatic solid tumors. Subjects eligible for treatment include those whose disease is refractory to standard therapeutic options, or for which there are no standard therapeutic options available. All enrolled patients will orally administer SR-8541A daily. Treatment may continue until the subject's disease worsens or another treatment discontinuation criterion is met. The combination part will only commence once the SRC has deemed it safe to proceed and a SR-8541A dose from the dose escalation part is selected as the RP2D. The ICI will be either nivolumab or pembrolizumab and dosing will be per SOC. Both investigational products will start on C1D1. Treatment with ICI may be continued if SR-8541A is discontinued and treatment with SR-8541A may be continued after ICI is discontinued. Approximately 10 subjects will be enrolled.

Conditions

• Advanced / Metastatic Solid Tumor

Interventions

Type	Name	Description
DRUG	SR-8541A	orally administered ENPP1 inhibitor
DRUG	Immune checkpoint inhibitor (ICI)	The ICI will be either nivolumab or pembrolizumab.

Timeline

• Start date: 2023-10-12
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-10-02
• Last updated: 2025-06-08

Locations

3 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study