In short
Clinical trials are studying Roginolisib in several cancers and blood diseases. These studies look at safety, tolerability, and how well the treatment works in people with advanced metastatic ocular/uveal melanoma, myelofibrosis, relapsed or refractory peripheral T-cell lymphomas, and advanced non-squamous non-small cell lung cancer.
Key points
- Clinical trials are studying Roginolisib in several different diseases, including advanced metastatic ocular/uveal melanoma, myelofibrosis, relapsed or refractory peripheral T-cell lymphomas, and advanced non-squamous non-small cell lung cancer. The studies are in Phase 1 and Phase 2, so they are checking both early safety questions and possible benefit. Some trials test Roginolisib alone, while others test it with other treatments such as ruxolitinib, dostarlimab, or docetaxel. The main outcomes include safety, tolerability, overall survival, maximum tolerated dose, recommended phase II dose, modified progression-free survival, and changes in immune cells. All listed studies are authorised and are designed for specific patient groups with advanced or hard-to-treat disease.
Overview of the clinical trials
Four authorised interventional studies are investigating Roginolisib in different disease settings.
These studies are in Phase 1 or Phase 2, which means they are still testing important research questions such as safety, dose, and possible benefit.
The trials include both single-treatment and combination-treatment designs, so researchers are looking at Roginolisib by itself and together with other cancer treatments.
Advanced metastatic ocular/uveal melanoma study
This Phase 2 study is enrolling people with advanced metastatic ocular/uveal melanoma, and it is authorised.
The main goal is to compare Roginolisib as a single agent against the investigator’s choice of therapy, with overall survival as the key outcome.
Overall survival means the time from randomisation until death from any cause.
This trial plans to enrol 85 participants.
Myelofibrosis study
This Phase 1 study is for people with myelofibrosis who are unresponsive to JAK inhibitors, and it is authorised.
The study looks at the safety and tolerability of Roginolisib when given in combination with ruxolitinib.
Safety is measured using adverse events, 12-lead ECG, serum chemistry and haematology laboratory tests, vital signs, and physical examinations.
This trial plans to enrol 27 participants.
Relapsed or refractory peripheral T-cell lymphoma study
This authorised Phase 1 platform trial is studying relapsed or refractory peripheral T-cell lymphomas.
A platform trial is a study design that can test more than one treatment option in the same overall trial structure.
For the Roginolisib-related sub-study, the early goal is to find the maximum tolerated dose and the recommended phase II dose.
The study uses dose-limiting toxicities to help decide the maximum tolerated dose.
In the later phase, the study measures modified progression-free survival, which counts disease progression, relapse after response, extra unplanned anti-lymphoma treatment, or death.
This trial plans to enrol 80 participants.
Advanced non-squamous non-small cell lung cancer study
This authorised Phase 1/IIa study is for advanced non-squamous non-small cell lung cancer.
The trial is testing Roginolisib with dostarlimab, with or without docetaxel.
One main goal is to evaluate safety and tolerability of the combinations.
Another goal is to compare treatment arms by looking at the proportion of patients who have a reduction in peripheral blood Tregs, which are regulatory T cells in the blood.
The primary outcome also includes a change from baseline of at least 50% by Day 42 as measured by mass cytometry, a lab method that measures many cell markers at once.
This trial plans to enrol 51 participants.
Main outcomes being measured
The trials focus on different outcomes depending on the disease and phase.
- Overall survival is used in the melanoma study to see how long people live after randomisation.
- Safety and tolerability are central in the myelofibrosis and lung cancer studies, because early trials need to know whether the treatment can be given safely.
- Maximum tolerated dose and recommended phase II dose are important in the lymphoma study because they help define a usable dose for later research.
- Modified progression-free survival is used in the lymphoma study to track whether the disease gets worse or whether other major treatment changes are needed.
- Immune cell changes, including peripheral blood Tregs, are measured in the lung cancer study to compare how the treatment arms affect the immune system in the blood.
Who the trials are for
These studies are not for a general population; each one targets a specific group with advanced or hard-to-treat disease.
- People with advanced metastatic ocular/uveal melanoma are being studied in one Phase 2 trial.
- People with myelofibrosis unresponsive to JAK inhibitors are being studied in one Phase 1 trial.
- People with relapsed or refractory peripheral T-cell lymphomas are being studied in one Phase 1 platform trial.
- People with advanced non-squamous non-small cell lung cancer are being studied in one Phase 1/IIa trial.