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ACTIVE NOT RECRUITING
NCT05653869
PHASE1

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

Sponsor: Applied Pharmaceutical Science, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

108

Start Date

2023-02-06

Completion Date

2026-10

Last Updated

2026-01-22

Healthy Volunteers

No

Interventions

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.

Locations (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China