Table of Contents
- Trial overview
- Who the trials include
- Study phases and goals
- What the trials measure
- Treatment approaches being tested
- Trial status and size
Trial overview
The available study is an interventional trial of Apl-101 in advanced MET-expressing solid tumors, including non-small cell lung cancer and central nervous system tumors.[1] The study is designed to evaluate safety, effectiveness, and the best dose for later testing.[1]
Who the trials include
The trial includes people with selected advanced solid tumors and NSCLC with MET aberrations.[1] The Phase 2 part also targets people with NSCLC harboring MET exon 14 skipping mutations, MET amplification, or EGFR activating mutations with acquired resistance and MET amplification after prior EGFR inhibitor treatment.[1]
The study also includes pan-cancers, which means different kinds of solid tumors grouped together if they share the same MET change.[1] Primary CNS tumors with MET alterations are also part of the planned Phase 2 evaluation.[1]
Study phases and goals
This study has a completed Phase 1 part and a Phase 2 part.[1] Phase 1 aimed to assess overall safety and tolerability, find dose-limiting toxicities, identify the recommended Phase 2 dose, and collect early pharmacokinetic data, which means how the body absorbs and handles the treatment.[1]
Phase 2 is focused on how well Apl-101 works as a monotherapy, meaning used alone, in several MET-driven cancer groups.[1] It also studies Apl-101 as an add-on to an EGFR inhibitor in a specific group of NSCLC patients who developed acquired resistance with MET amplification.[1]
What the trials measure
One key Phase 1 endpoint is the maximum tolerated dose (MTD), which is the highest dose that can be given with acceptable side effects.[1] The study also measures dose-limiting toxicities, sustained Grade 2 adverse events, dose reductions, dose interruptions, delayed toxicities, and other adverse events to help choose the recommended Phase 2 dose.[1]
In Phase 2, the main outcome is objective response rate (ORR), which combines complete response and partial response.[1] Tumor response is judged by independent review using RECIST v1.1 for many solid tumors and RANO criteria for CNS tumors, with other tumor-specific criteria used when needed.[1]
Treatment approaches being tested
Apl-101 is being studied as a single treatment in several cancer groups with MET changes.[1] This includes NSCLC with MET exon 14 skipping mutations, NSCLC with MET amplification, pan-cancers with MET amplification, pan-cancers with MET fusion, primary CNS tumors with MET alterations, and pan-cancers with wild-type MET plus HGF and MET overexpression.[1]
The trial also studies Apl-101 together with an EGFR inhibitor for people with NSCLC who first responded to EGFR inhibitor treatment, then later had disease progression and MET amplification.[1] In this setting, the study looks at whether adding Apl-101 may help after resistance has developed.[1]
Trial status and size
The trial is listed as authorised and is an interventional study.[1] The enrollment number is 497, which means the study planned to include 497 participants.[1]
