In short
TLN-372 is an investigational oral medication being studied for the treatment of advanced solid tumors with a KRAS gene mutation. It is currently being tested both on its own and in combination with other cancer therapies. A Phase 1/2 clinical trial with 270 participants is now authorised to evaluate the safety and anti-tumor activity of TLN-372 in patients with locally advanced or metastatic KRAS-mutant cancers.
Key points
- TLN-372 is an investigational drug given by mouth (orally) for advanced solid tumors with a KRAS mutation.
- The trial is in Phase 1/2, combining early safety testing with initial measures of effectiveness.
- The study plans to enroll 270 patients with locally advanced or metastatic solid tumors.
- Researchers will measure side effects, dose-limiting toxicities, and the objective response rate of the tumor.
- The trial is currently authorised, meaning it has received regulatory approval to begin enrolling patients.
- TLN-372 is being tested alone and in combination with cetuximab or pembrolizumab.
What is TLN-372?
TLN-372 is an investigational medication, meaning it has not yet been approved as a medicine for general use. It is being developed as a potential treatment for advanced solid tumors that carry a KRAS gene mutation. The drug is given by mouth (orally). In the registry records, TLN-372 is listed as the active substance being tested in a Phase 1/2 clinical trial.
How does TLN-372 work?
The mechanism of action of TLN-372 is not described in the registry data provided. The trial focuses on patients with KRAS-mutant solid tumors, and TLN-372 is being investigated both as a single agent and in combination with other anti-tumor agents.
Which conditions is TLN-372 being studied for?
- Locally advanced or metastatic solid tumors — cancers that have grown into surrounding tissues or spread to other parts of the body and carry a KRAS gene mutation.
- KRAS-mutant colon cancer — a form of bowel cancer with a specific mutation in the KRAS gene, studied in combination with cetuximab.
- KRAS-mutant pancreatic cancer — a form of pancreatic cancer with a KRAS gene mutation, also studied in combination with cetuximab.
How is TLN-372 given?
TLN-372 is administered by mouth (orally). The trial also includes other medications given by different routes: itraconazole (an oral capsule), pembrolizumab (KEYTRUDA concentrate for solution for infusion, given intravenously), and cetuximab (Erbitux solution for infusion, given intravenously).
What do the clinical trials show?
The clinical trial programme for TLN-372 consists of one authorised Phase 1/2 study with a planned enrollment of 270 participants. The study is divided into three parts. Part 1A evaluates the safety and tolerability of TLN-372 as a single agent and estimates the maximum tolerated dose. Part 1B evaluates the safety and tolerability of TLN-372 in combination with cetuximab in patients with advanced or metastatic KRAS-mutant colon and pancreatic cancer, and estimates the maximum tolerated dose of the combination. Part 2 evaluates the anti-tumor activity of TLN-372 as a single agent and in combination with cetuximab, and evaluates the safety of TLN-372 in combination with pembrolizumab.
Who can take part in these trials?
The trial enrolls patients with locally advanced or metastatic solid tumors that carry a KRAS mutation. For the combination part with cetuximab, patients must have advanced or metastatic KRAS-mutant colon or pancreatic cancer.
What are the trials measuring?
The primary outcomes include the number of patients experiencing adverse events that meet protocol-defined dose-limiting toxicity criteria following administration of TLN-372, and the incidence and severity of treatment-emergent adverse events and treatment-related adverse events leading to dose modification and discontinuation. The trial also measures anti-tumor activity by evaluating the objective response rate (ORR) according to RECIST v1.1, a standard set of criteria used to assess how well a cancer responds to treatment.
What side effects are known?
The known side effects of TLN-372 are not described in the registry data provided. The trial is actively measuring the incidence and severity of treatment-emergent adverse events and treatment-related adverse events, and will report these results as the study progresses.