NCT06840886

A Study of PHST001 in Advanced Solid Tumors

An Open-label, Phase 1a/1b, Dose Escalation and Dose Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of PHST001 in Adult Patients With Advanced Relapsed and/or Refractory Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 155 (estimated)
• Sponsor: Pheast Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

PHST001-101 is a multicenter, open-label, Phase 1 study of PHST001 in patients with advanced solid tumors. The study design includes a Dose Escalation Phase and a Dose Expansion Phase, and will enroll patients with advanced relapsed and/or refractory solid tumors. The study's primary object is to evaluate the safety and tolerability of PHST001 and determine the RP2D (Recommended Phase 2 dose) of PHST001.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	PHST001	* PHST001 will be administered as IV infusions in a 3-week (Q3W) dosing interval. The dosing day will be on Day 1, 21 days cycle. * Other Names: * Dose Level 1 * Dose Level 2 * Dose Level 3 * Dose Level 4 * Dose Level 5 * Dose Level 6 * Dose Level 7 Drug: PHST001 * PHST001 will be administered as IV infusions in a 3-week (Q3W) dosing interval. The dosing day will be on Day 1, 21 days cycle. This study is an open label, Phase 1 dose escalation trial with three expansion cohorts. The study consists of two parts: * Part A: Dose escalation in patients with advanced solid tumors. Approximately 40-80 in total will be in enrolled in part A, covering 7 dose level. * Part B: Expansion cohorts will be added as an amendment as further preclinical data and clinical data from Part A become available.

Timeline

• Start date: 2025-03-31
• Primary completion: 2029-04-01
• Completion: 2031-04-01
• First posted: 2025-02-21
• Last updated: 2025-09-04

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study