Table of contents
- Trial overview
- Who can participate
- Study phases and treatments
- What researchers measure
- What this means for patients
Trial overview
The main study of Anv600 is EXPAND-1, a Phase 1/2 interventional trial in participants with advanced solid tumors.[1] The trial is authorised and plans to enroll 270 participants.[1]
Who can participate
This study is for people with advanced solid tumours, which means solid cancers that are advanced and may be harder to treat.[1] The data provided do not list more detailed entry rules, such as age limits or prior treatments.[1]
Study phases and treatments
The trial has two parts: Phase 1 and Phase 2.[1] In Phase 1, the study checks the maximum tolerated dose, which is the highest dose that can be given without too many serious side effects, and the recommended Phase II dose, which is the dose chosen for later testing.[1]
Researchers are studying Anv600 as a single agent, meaning by itself, and also in combination with pembrolizumab.[1] Pembrolizumab is listed as a study drug in the trial, but the source data do not give more detail about how the combination is being used.[1]
What researchers measure
In Phase 1, the main goals are to measure dose limiting toxicities and treatment-emergent adverse events with Anv600 alone and with pembrolizumab.[1] Dose limiting toxicities are side effects serious enough to limit the dose, and treatment-emergent adverse events are side effects that appear or worsen after treatment starts.[1]
In Phase 2, the study measures objective response rate and duration of response using RECIST v1.1.[1] Objective response rate shows the share of participants whose tumors shrink or disappear, while duration of response shows how long that benefit lasts.[1]
What this means for patients
This clinical program is an early study of Anv600 in advanced solid tumors, so the main focus is still learning about safety and finding the right dose.[1] The later part of the trial then looks for early signs that the treatment may help control the cancer.[1] Because the study includes both Anv600 alone and Anv600 with pembrolizumab, researchers can compare these two approaches within the same trial design.[1]
