NCT06526819

SMP-3124LP in Adults With Advanced Solid Tumors

An Open-label, Phase 1 Dose Escalation and Phase 2 Dose Expansion Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SMP-3124LP in Adults With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An Open-label, Phase I Dose Escalation and Phase 2 Dose Expansion Study to Assess Safety, Tolerability, Preliminary Antitumor Activity of SMP 3124LP in Adults with Advanced Solid Tumors

Detailed description

Phase 1/2, global, multicenter, open-label, first-in-human, clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of SMP-3124

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	SMP3124LP	Liposomal encapsulation formulation of SMP-3124

Timeline

• Start date: 2024-08-14
• Primary completion: 2028-12-01
• Completion: 2029-05-01
• First posted: 2024-07-30
• Last updated: 2026-02-27

Locations

10 sites across 2 countries: United States, Japan

Regulatory

• FDA-regulated drug study