This trial is a phase 1/2 open label, non-randomised clinical trial.
The primary outcome measure, which is used to assess the main aim of the study, is to determine the safety and tolerability of APL-101 in cancer patients. In the second part of the study, anti-tumour activity will be measured in terms of the reduction in the size of the tumour (response rate).
Secondary outcome measures are safety and tolerability of APL-101, how APL-101 moves around the body and is broken down (metabolised), how long the treatment stops the cancer from growing (progression-free survival), and overall survival time.
The study is looking to recruit 201 people from the UK, Australia, Canada, Finland, France, Italy, Puerto Rico, Russia, Singapore, Spain, Taiwan, Ukraine, and the USA.
APL-101 is a capsule that you take by mouth on a daily basis throughout the treatment phase of the study.
There are two parts to this study; the dose escalation and safety study (phase 1) and the efficacy study (phase 2).
In phase 1, small groups of patients will be given APL-101. The first small group of patients will be given the lowest dose of APL-101. The study team will review the safety results of this dose before proceeding with the next group of patients. The second group of patients will have a higher dose of APL-101. The study team will continue to increase the dose until the best dose is found. This is called a dose-escalation study.
In phase 2, there will be five groups of patients with c-MET gene mutations. The first three groups are for people with non-small cell lung cancer (NSCLC). Groups C and D are for people with kidney cancer, non-small cell lung cancer, stomach cancer, gastro-oesophageal junction adenocarcinoma, lung cancer, brain tumour, glioblastoma multiforme, and other advanced solid tumours:
- Group A-1: NSCLC EXON 14 skip mutation (c-Met naïve, 1L)
- Group A-2: NSCLC EXON 14 skip mutation (c-Met naïve, 2/3L),
- Group B: NSCLC EXON 14 skip mutation (c-Met experienced; progressed on prior c-Met inhibitor),
- Group C: basket of tumour types (with c-Met high-level amplifications),
- Group D: basket of tumour types (with c-Met fusions)
Patients in phase 2 of the study will be treated with the best dose found from phase 1 of the study.
You will continue to be treated in this study for as long as your doctor feels you are benefiting from the treatment, or until you experience unacceptable severe side effects, or your cancer starts growing again (progresses), or you have a complete response. If you no longer want to take part in the study, you can withdraw your consent and stop study treatment at any time.
