NCT04328740

Phase 1 Study of Oral TP-1454

A Phase I, First-in-human, Open-label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP 1454

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and tolerability of oral TP-1454 in patients with advanced metastatic or progressive solid tumors and anal cancer.

Detailed description

Primary Objective: • To establish the MTD and/or Recommended Phase 2 Dose (RP2D) of orally administered TP-1454 in patients with metastatic solid tumors and anal cancer. Secondary Objectives: * To establish the pharmacokinetic (PK) profile of orally administered TP-1454 * To observe patients for any evidence of antitumor activity of TP 1454 by objective radiographic assessment * To assess the safety and tolerability of TP-1454

Conditions

• Advanced Solid Tumor
• Anal Cancer

Interventions

Type	Name	Description
DRUG	TP-1454 monotherapy	Flat dose once or twice daily, alone

Timeline

• Start date: 2020-07-08
• Primary completion: 2025-04-25
• Completion: 2025-04-25
• First posted: 2020-03-31
• Last updated: 2025-05-01

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study