Precision oncology firm Notable Labs is launching its first self-sponsored clinical trial, designed from the ground up to help validate its cancer patient matching platform over the long term.
The observational study—which also represents the company’s largest trial to date—aims to enroll up to 1,000 participants with a variety of blood cancers and will follow them for at least one year as they receive physician-led standard-of-care therapies at different sites across the U.S. and Canada.
Separately, Notable’s phenotypic and artificial intelligence-powered platform will be tested against multiple patient samples collected over time to provide a longitudinal view of its predictive value based on cancer mutations, drug responses and the outcomes of each participant.
It will also search for patterns useful in the development of new treatments. The company combines AI approaches with automated lab processes to determine which drugs or combinations will be most effective for specific cancers.
“This will really let us look at drug resistance and cancer evolution in patients in real time, and how that affects the laboratory results,” said Notable CEO Matt De Silva in an interview with FierceMedTech. “Specifically, can we measure how the cancer is changing, and in particular, how is it changing in response to drugs.”
“Say you get treated with the standard-of-care agents for your type of blood cancer—the thinking is that that treatment can make you resistant to other therapies, which may or may not be true, but it also could make you sensitive to other drugs,” said De Silva. “And so by taking samples over time, we can look for how that drug sensitivity changes to help design therapies and combinations that are much more effective than the standard treatment.”
The study’s resulting tumor registry will include both newly diagnosed cancer patients and those who have previously received treatment and have progressed. It will also provide opportunities to study the course of diseases such as acute myeloid leukemia (AML).
“Gathering samples over time from the same patient is one of the things we have not been able to do in the other studies that we’ve joined [with our academic research and biopharmaceutical industry partners],” said Notable Chief Medical Officer Hiroomi Tada.
“This provides us with the longitudinal data to understand, for each individual patient, how the disease evolves when they’re given a specific treatment, and if new vulnerabilities become revealed to different classes of agents that you might not normally think about,” Tada said.
The company plans to employ a rolling protocol design, which will begin by enrolling patients in myeloid-based malignancies including AML, myelofibrosis and myelodysplastic syndrome before adding more indications over time.
“As we gain more experience and confidence with B-cell malignancies, we’ll start working in multiple myeloma and acute B-cell leukemia, as well as chronic lymphocytic leukemia,” Tada said. “We’ll broaden the scope of the study as we broaden the application of the platform.”