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Clinical Trials in China / NCT05653869
Active, not recruiting Phase 1

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

NCT05653869 · tracked via the Priya Life Science China tracker
Sponsor
Applied Pharmaceutical Science, Inc
Phase
Phase 1
Started
2023-02-06
Last updated
2026-01-22

Condition(s) studied

RET-altered Solid Tumors

Investigational drug(s) / intervention(s)

APS03118

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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Male or female patients aged 18 years or older 2. Have histological or cytological confirmation of unresectable locally advanced or metastatic solid tumors harboring oncogenic RET mutations or fusions confirmed by NGS. Site may identify patients with a RET-mutated or RET-fusion solid tumor before the formal screening. 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 4. Resolution of all toxic effects of prior therapies to Grade 1 or below according to NCI CTCAE version 5.0 (except alopecia or Grade 2 neuropathy); 5. Patients with asymptomatic brain metastases if they have been previously treated, demonstrated no progression at least for 1 months before Screening, are asymptomatic and have had no requirement for steroids or enzyme inducing anticonvulsants in the last 14 days before Screening 6. Adequate organ function Exclusion Criteria: 1. Have a locally advanced solid tumor that is a candidate for curative surgery treatment through radical surgery and/or radiotherapy. 2. Have an active fungal, bacterial, and/or active untreated viral infection 3. The patient has a serious pre-existing medical condition(s) 4. Have received or will receive a COVID-19 vaccine within 1 month before the first dose of APS03118.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghai Chest Hospital Shanghai Shanghai Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05653869 on ClinicalTrials.gov ↗ ← All trials in China