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

NCT05653869 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2026-01-22

No results posted yet for this study

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.

Conditions

  • RET-altered Solid Tumors

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.

Sponsors & Collaborators

  • Applied Pharmaceutical Science, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-06
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05653869 on ClinicalTrials.gov