NCT07123415

A Phase 1 Study of APX-343A as Monotherapy or in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

A Phase 1 Trial of APX-343A as Monotherapy or in Combination With Pembrolizumab to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy in Subjects With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Aptabio Therapeutics, Inc. · Individual
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, open-label, dose-escalation study to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of APX-343A monotherapy (Part A) and in combination with pembrolizumab (Part B) in subjects with advanced solid tumors.

Conditions

• Advanced Solid Cancer
• Advanced Solid Tumor (Phase 1)

Interventions

Type	Name	Description
DRUG	APX-343A	Oral administration twice daily
DRUG	Pembrolizumab	intravenous \[IV\]

Timeline

• Start date: 2025-10-24
• Primary completion: 2028-10-01
• Completion: 2028-12-01
• First posted: 2025-08-14
• Last updated: 2025-11-19

Locations

3 sites across 1 country: South Korea