Phase
Condition
Neoplasms
Treatment
APS03118
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female patients aged 18 years or older
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.
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 toNCI 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 asymptomaticand have had no requirement for steroids or enzyme inducing anticonvulsants in thelast 14 days before Screening
Adequate organ function
Exclusion
Exclusion Criteria:
Have a locally advanced solid tumor that is a candidate for curative surgerytreatment 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 firstdose of APS03118.
Study Design
Study Description
Connect with a study center
Shanghai Chest Hospital
Shanghai, Shanghai 200030
ChinaSite Not Available
Shanghai Chest Hospital
Shanghai 1796236, Shanghai Municipality 1796231 200030
ChinaSite Not Available

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