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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
108
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.
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Incidence of DLTs during Cycle 1 in dose-escalation cohorts
Time frame: 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)
Time frame: Approximately 15 months
Adverse events(AE)
Time frame: Approximately 24 months
Peak Plasma Concentration (Cmax)
Time frame: Up to approximately 1 month
Area under the plasma concentration versus time curve (AUC)
Time frame: Up to approximately 1 month
Time to Maximum Concentration (Tmax)
Time frame: Up to approximately 1 month
Degree of accumulation
Time frame: Up to approximately 1 month
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
Duration of response (DOR)
Time frame: Up to approximately 24 months
Best of response (BOR)
Time frame: Up to approximately 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Disease Control Rate (DCR)
Time frame: Up to approximately 24 months
Progress Free Survival (PFS)
Time frame: Up to approximately 24 months