Table of Contents
Trial overview
The clinical trial NCT04526106 was a first-in-human study of Rly-4008 in patients with cholangiocarcinoma and other advanced solid tumors.[1] It was an interventional study, which means patients received the study drug as part of the research plan.[1]
The trial was completed and included 462 participants.[1] It was a Phase 1/2 study, so it was designed to learn early safety information and also look for signs that the treatment may help.[1]
Who was studied
The study focused on people with cholangiocarcinoma (CCA) and other advanced solid tumors.[1] Cholangiocarcinoma is a cancer that starts in the bile ducts, which are tubes that carry bile from the liver to the intestine.
“Advanced solid tumors” means solid cancers that have spread or are harder to control with standard treatment.[1] The source data do not list the full entry rules, so the exact participation criteria are not available here.
What was measured
The main early goals were to find the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of Rly-4008.[1] MTD means the highest dose that can be given without unacceptable side effects, while RP2D is the dose chosen for later study based on safety and other findings.
Researchers also studied the overall safety profile and tolerability of Rly-4008.[1] Tolerability describes how well patients can handle treatment without major problems.
In Parts 2 and 3, the study measured objective response rate (ORR) using an Independent Review Committee and RECIST v.1.1 rules.[1] ORR shows how many patients had clear tumor shrinkage on scans.
In Part 4, the trial tracked the frequency, severity, timing, and relationship of adverse events and serious adverse events to Rly-4008, as well as dose modifications.[1] An adverse event is any unwanted medical problem that happens during a study, whether or not it is caused by the treatment.
Trial phases and parts
This study was divided into several parts, each with a different goal.[1]
Part 1 focused on dose finding and early safety, including MTD, RP2D, and the overall safety profile.[1]
Parts 2 and 3 focused on efficacy, meaning whether the treatment showed signs of helping the cancer respond.[1]
Part 4 focused again on safety and tolerability, with more detail on side effects and dose changes.[1]
How results were judged
The trial used an Independent Review Committee (IRC) to assess response in Parts 2 and 3.[1] This means experts reviewed the scan results separately from the study team to help make the response assessment more objective.
The study used RECIST v.1.1, which is a standard way to measure tumor size on scans and decide whether cancer is responding.[1] Using a standard method helps make the results easier to compare and understand.
