NCT05653869

A Study of APS03118 in Advanced Solid Tumors Harboring RET Mutations or Fusions

A Phase 1/1b Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of APS03118 in Adult Patients With Unresectable Locally Advanced or Metastatic Solid Tumors Harboring RET Mutations or Fusions

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Applied Pharmaceutical Science, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/1b, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antineoplastic activity of APS03118 administered orally in participants with RET-altered solid tumors.

Detailed description

After being informed about the study procedure and potential risks and benefits, all patients giving written informed consent will undergo a 4-week screening period to determine eligibility for study entry. The eligible participants will be enrolled using a rolling 6 dose escalation scheme to identify MTD and/or RP2D.

Conditions

• RET-altered Solid Tumors

Interventions

Type	Name	Description
DRUG	APS03118	Participant received APS03118 orally until evidence of unacceptable toxicity, progressed disease, consent withdrawal or with drawl from the study at the discretion of the investigator.

Timeline

• Start date: 2023-02-06
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2022-12-16
• Last updated: 2026-01-22

Locations

1 site across 1 country: China