In short
Clinical trials of Avutometinib are studying how well it works and how safe it is in specific cancers. The main trials here include people with recurrent low-grade serous ovarian cancer and patients with non-small cell lung cancer. These studies look at response to treatment, disease control, and other outcomes.
Key points
- Clinical trials of Avutometinib are being done in recurrent low-grade serous ovarian cancer and non-small cell lung cancer. The studies include Phase 1, Phase 2, and Phase 3 research, so they are looking at early safety, signs of benefit, and larger comparisons. Some trials test Avutometinib alone, while others test it with defactinib or sotorasib. The main outcomes include overall response rate, progression-free survival, and safety measures such as dose-limiting toxicities and adverse events. These trials focus on patients with recurrent disease or specific cancer features, such as G12C in lung cancer.
Clinical trials overview
These studies are testing Avutometinib in people with cancer, mainly in recurrent low-grade serous ovarian cancer and non-small cell lung cancer.
The trials are designed to learn whether Avutometinib works, how well it can be combined with other treatments, and what outcomes should be measured in later research.
Recurrent low-grade serous ovarian cancer studies
NCT04625270 is a Phase 2 study in recurrent low-grade serous ovarian cancer, also called LGSOC. It includes four parts and compares Avutometinib alone with Avutometinib plus defactinib, then looks more closely at the most promising regimen.
The main goal in Part A is to find the best regimen for later testing, while Parts B and C evaluate how well that regimen works. Part D studies a lower dose of Avutometinib with defactinib.
Non-small cell lung cancer study
NCT05074810 is a Phase 1/2 study in patients with non-small cell lung cancer and a G12C change. The study tests Avutometinib with sotorasib and first looks at dose and safety before moving to dose expansion.
In Part A, the study checks dose-limiting toxicities, adverse events, serious adverse events, physical exams, lab values, and how well the treatment is tolerated. In Part B, it measures confirmed overall response rate.
What the trials measure
The ovarian cancer studies use overall response rate as the main endpoint, which means the share of patients whose tumors shrink or disappear based on RECIST 1.1 criteria.
The Phase 3 ovarian cancer study uses progression-free survival, which is the time before the cancer gets worse, as its main outcome.
The lung cancer study measures safety-related outcomes first, then confirmed overall response rate in the expansion part.
Trial phases and study design
The Avutometinib trials include Phase 1, Phase 2, and Phase 3 research. Phase 1 focuses on dose finding and safety, Phase 2 looks for early signs that treatment may help, and Phase 3 compares treatment options in a larger group.
The Phase 3 study is randomized and open-label, which means patients are assigned to treatment groups by chance and both the patient and study team know which treatment is given.
Who the trials are for
The ovarian cancer trials are for people with recurrent low-grade serous ovarian cancer, meaning the cancer has come back after treatment.
The lung cancer trial is for patients with non-small cell lung cancer, specifically those with a G12C change.
Across the studies, Avutometinib is being tested alone or with other drugs such as defactinib and sotorasib, and one Phase 3 study compares the combination with investigator’s choice of treatment.