In short
RO7782493 (also known as GDC-7035) is an investigational oral anti-cancer agent being studied in people with advanced or metastatic solid tumors that carry a KRAS G12D mutation. A single authorised Phase 1/2 trial in the EU registry plans to enroll up to 701 participants and tests the drug alone and in combination with panitumumab. The trial is currently in the Authorised stage, meaning it is cleared to start but not yet recruiting.
Key points
- RO7782493 is an investigational oral medicine targeting the KRAS G12D mutation.
- The trial is Phase 1/2 and is currently Authorised in the EU registry.
- It plans to enroll up to 701 participants with advanced or metastatic solid tumors.
- The study tests RO7782493 alone and in combination with panitumumab.
- Main goals include measuring safety, side effects, and dose-limiting toxicities.
- RO7782493 is taken orally, while panitumumab is given by IV infusion.
What is RO7782493?
RO7782493, also referred to as GDC-7035, is an investigational anti-cancer substance being developed for the treatment of solid tumors. It belongs to a class of medicines that target a specific genetic change called the KRAS G12D mutation. This mutation drives uncontrolled growth in certain cancer cells. RO7782493 is not yet an authorised medicine; it is being evaluated in clinical research.
How does RO7782493 work?
RO7782493 is designed to act on cancer cells that carry the KRAS G12D mutation. The KRAS protein normally helps control cell growth, but when mutated it can become stuck in an "on" position, telling cancer cells to keep dividing. RO7782493 is being studied for its ability to interfere with this mutated protein. The trial also tests the drug in combination with panitumumab, an antibody that blocks a different growth signal on cancer cells.
Which conditions is it studied for?
- Advanced or metastatic solid tumors with KRAS G12D mutation — cancers that have spread beyond their original site and carry this specific genetic change.
How is RO7782493 given?
RO7782493 is taken by mouth as an oral formulation. Panitumumab, the combination partner in this study, is given by intravenous (IV) infusion.
What do the clinical trials show?
One EU-registered trial is evaluating RO7782493. It is a Phase 1/2 study with a planned enrollment of up to 701 participants. The trial is currently in the Authorised status, meaning it has received approval to proceed but is not yet recruiting patients.
The study has two main parts. In the Phase 1 part, researchers determine the safe dose and look at how the body processes the drug (pharmacokinetics). In the Phase 2 part, they look for signs of anti-tumor activity. The trial tests RO7782493 as a single agent and in combination with panitumumab.
The primary outcomes focus on safety: the incidence and severity of adverse events graded by the NCI CTCAE v5.0 scale, the incidence of dose-limiting toxicities (side effects severe enough to prevent a higher dose), changes in vital signs, clinical laboratory test results, and targeted ECG parameters.
What side effects are known?
No side effect data are available from the current registry record. The trial is designed to collect safety information, including adverse events and dose-limiting toxicities, but results have not yet been reported.