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Active, not recruitingNCT05653869Updated Jan 22, 2026

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

A Phase 1 interventional study of APS03118 in RET-altered Solid Tumors, sponsored by Applied Pharmaceutical Science, Inc.. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-22.

Sponsored by Applied Pharmaceutical Science, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
108
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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.

Read the detailed 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.

02

Conditions studied

  • RET-altered Solid Tumors
03

In context

Lead sponsor

This is the only study on the registry with Applied Pharmaceutical Science, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
108 participants (actual)

Study arms

  • Experimental
    APS03118 Dose Escalation

    APS03118 administered orally

    Drug: APS03118

Interventions

  • DrugAPS03118

    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.

    Also known as: APS03118 administrated orally

06

What researchers measure

Primary outcomes

  1. Incidence of DLTs during Cycle 1 in dose-escalation cohorts

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

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

    The MTD is defined as the maximum dose at which the incidence of dose-limiting toxicities (DLTs) during Cycle 1 is below 30%(\<2/6)

    Time frame: Approximately 15 months

Secondary outcomes

  1. Adverse events(AE)

    Time frame: Approximately 24 months

  2. Peak Plasma Concentration (Cmax)

    Time frame: Up to approximately 1 month

  3. Area under the plasma concentration versus time curve (AUC)

    Time frame: Up to approximately 1 month

  4. Time to Maximum Concentration (Tmax)

    Time frame: Up to approximately 1 month

  5. Degree of accumulation

    Time frame: Up to approximately 1 month

  6. Overall Response Rate (ORR)

    As assessed by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

    Time frame: Up to approximately 24 months

  7. Duration of response (DOR)

    Time frame: Up to approximately 24 months

  8. Best of response (BOR)

    Time frame: Up to approximately 24 months

  9. Disease Control Rate (DCR)

    Time frame: Up to approximately 24 months

  10. Progress Free Survival (PFS)

    Time frame: Up to approximately 24 months

07

Study locations

1 site
  • Shanghai Chest Hospital
    Shanghai, Shanghai Municipality 200030, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05653869
Lead sponsor
Applied Pharmaceutical Science, Inc.
Responsible party
Sponsor
First posted
Dec 16, 2022
Start date
Feb 6, 2023
Primary completion
Oct 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Jan 22, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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