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

NCT05653869 | Active Not Recruiting Phase 1

• 1 other identifier: APS-RET-102
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

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

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

• 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)

  Approximately 15 months

Secondary Outcomes (10)

• Adverse events(AE)

  Approximately 24 months

• Peak Plasma Concentration (Cmax)

  Up to approximately 1 month

• Area under the plasma concentration versus time curve (AUC)

  Up to approximately 1 month

• Time to Maximum Concentration (Tmax)

  Up to approximately 1 month

• Degree of accumulation

  Up to approximately 1 month

Study Arms (1)

APS03118 Dose Escalation

EXPERIMENTAL

APS03118 administered orally

Drug: APS03118

Interventions

APS03118 DRUG

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

APS03118 Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Applied Pharmaceutical Science, Inc.: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 16, 2022
• Study Start: February 6, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)