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Also known as Selitrectinib (BAY2731954), Selitrectinib (BAY2731954) Oral solution
Selitrectinib · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm_25 + 75 mg (Fasted) | EXPERIMENTAL | Healthy male participants receive a single dose of 25 mg selitrectinib (Period 1) and 75 mg selitrectinib (Period 2) in fasted state. |
| Arm_50 + 50 mg (Fasted/Fed) | EXPERIMENTAL | Healthy male participants receive a single dose of 50 mg selitrectinib in fasted state (Period 1) and 50 mg selitrectinib in fed state (Period 2). |
| Arm_100 + 150 mg (Fasted) | EXPERIMENTAL | Healthy male participants receive a single dose of 100 mg selitrectinib (Period 1) and 150 mg selitrectinib (Period 2) in fasted state. |
| Cancer participants <12 years | EXPERIMENTAL | A Rolling-6 dose escalation design will be used. The starting dose for participants age \< 12 years will be 25% below the highest dose level cohort divided by 1.73 m\^2 cleared by the Safety Review Committee (SRC) for subjects age 12 years and older. |
| Cancer participants ≥12 years | EXPERIMENTAL | A 3+3 dose escalation design will be used to determine the maximum tolerated dose (MTD)/recommended dose for further study, enrolling 3 to 6 participants per cohort with a starting dose level of 100 mg twice daily (BID). |
| Name | Type | Description |
|---|---|---|
| Selitrectinib (BAY2731954) | DRUG | Selitrectinib is administered orally as liquid suspension (20 mg/mL) on Day 1 of each period. Each period lasts 4 days, both periods of each arm are separated by at least 3 days. |
Inclusion Criteria: * Participants who are overtly healthy as determined by the investigator or medically qualified designee based on medical evaluation including medical history, laboratory tests, physical, cardiac and neurologic examination * Body mass index (BMI): ≥18.5 and ≤ 29.9 kg/m2, with bo...
Selitrectinib is an investigational small molecule being studied for the treatment of solid tumors harboring NTRK fusion. It is not approved for any indication and remains in clinical development. The research program targets cancers driven by NTRK gene fusions, a biomarker-selected patient population.
Selitrectinib targets NTRK1, NTRK2, and NTRK3, the three tropomyosin receptor kinase genes. It is an inhibitor of these kinases. NTRK fusions produce abnormal TRK fusion proteins that drive tumor growth, and inhibiting NTRK1, NTRK2, and NTRK3 is the intended mechanism of action.
Selitrectinib is being developed by Bayer AG, which trades under the ticker BAYRY. Bayer is the sponsor of the clinical program evaluating the drug in solid tumors harboring NTRK fusion.
Selitrectinib is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any other regulatory authority. The program consists of two completed Phase 1 trials with a combined enrollment of 105 participants.
Selitrectinib has been studied in two completed Phase 1 trials. NCT03215511 tested the safety of selitrectinib in children and adults with solid tumors harboring NTRK fusion across the United States, Australia, Belgium, Denmark, France, Germany, Ireland, Italy, Singapore, and Spain. NCT04275960 was a healthy adult male participant study in Germany examining absorption, distribution, excretion, and food interaction.
Yes, Selitrectinib is also known as BAY2731954. The oral solution form is referred to as Selitrectinib (BAY2731954) Oral solution. These names refer to the same investigational compound developed by Bayer AG.