Active — Not RecruitingPhase 1

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

China108 participantsStarted 2023-02-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or female patients aged 18 years or older
✓. 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.
✓. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
✓. 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);
✓. 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
✓. Adequate organ function

Exclusion criteria

✕. Have a locally advanced solid tumor that is a candidate for curative surgery treatment through radical surgery and/or radiotherapy.
✕. Have an active fungal, bacterial, and/or active untreated viral infection
✕. The patient has a serious pre-existing medical condition(s)
✕. Have received or will receive a COVID-19 vaccine within 1 month before the first dose of APS03118.

What they're measuring

Incidence of DLTs during Cycle 1 in dose-escalation cohorts

Timeframe: Within the 28 days of the first APS03118 dose for each patient

The maximum tolerated dose (MTD) and / or recommended Phase II dose (RP2D)

Timeframe: Approximately 15 months

Trial details

NCT IDNCT05653869

SponsorApplied Pharmaceutical Science, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10

View on ClinicalTrials.gov More RET-altered Solid Tumors trials