Clinical trial · Interventional
A Study of APS03118 in Advanced Solid Tumors Harboring RET Mutations or Fusions
A Phase 1/1b Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of APS03118 in Adult Patients With Unresectable Locally Advanced or Metastatic Solid Tumors Harboring RET Mutations or Fusions
NCT05653869CI-TRIAL-00101370active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| RET-altered Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| APS03118 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- APS03118 Dose Escalation
- description
- APS03118 administered orally
- interventionNames
- Drug: APS03118
Primary outcomes (2)
- measure
- Incidence of DLTs during Cycle 1 in dose-escalation cohorts
- timeFrame
- Within the 28 days of the first APS03118 dose for each patient
- measure
- The maximum tolerated dose (MTD) and / or recommended Phase II dose (RP2D)
- timeFrame
- Approximately 15 months
- description
- 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)
Secondary outcomes (10)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.