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

Last updated: January 20, 2026
Sponsor: Applied Pharmaceutical Science, Inc.
Overall Status: Active - Not Recruiting

Phase

1

Condition

Neoplasms

Treatment

APS03118

Clinical Study ID

NCT05653869
APS-RET-102
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Male or female patients aged 18 years or older

  2. Have histological or cytological confirmation of unresectable locally advanced ormetastatic solid tumors harboring oncogenic RET mutations or fusions confirmed byNGS. Site may identify patients with a RET-mutated or RET-fusion solid tumor beforethe 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 toNCI 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 asymptomaticand have had no requirement for steroids or enzyme inducing anticonvulsants in thelast 14 days before Screening

  6. Adequate organ function

Exclusion

Exclusion Criteria:

  1. Have a locally advanced solid tumor that is a candidate for curative surgerytreatment 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 firstdose of APS03118.

Study Design

Total Participants: 108
Treatment Group(s): 1
Primary Treatment: APS03118
Phase: 1
Study Start date:
February 06, 2023
Estimated Completion Date:
October 31, 2026

Study 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.

Connect with a study center

  • Shanghai Chest Hospital

    Shanghai, Shanghai 200030
    China

    Site Not Available

  • Shanghai Chest Hospital

    Shanghai 1796236, Shanghai Municipality 1796231 200030
    China

    Site Not Available

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