Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 developed for solid tumors harboring NTRK fusion. It is designed to treat cancers that have a specific genetic alteration known as an NTRK fusion. The drug is currently in clinical development and has not been approved by regulatory authorities.
Selitrectinib is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded under the ticker symbol BAYRY. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with NTRK fusion-positive solid tumors.
Selitrectinib is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies. The Phase 1 trials have been completed, and the drug is no longer in active clinical testing according to the available trial data.
Selitrectinib has been studied in two completed Phase 1 clinical trials. The first trial, NCT03215511, enrolled 81 children and adults with solid tumors harboring NTRK fusion across multiple countries. The second trial, NCT04275960, enrolled 24 healthy adult male participants in Germany to study how the body absorbs, distributes, and excretes the drug.
Selitrectinib targets cancers that harbor NTRK fusion, a genetic alteration that can drive tumor growth. By acting on this specific molecular target, the drug aims to interfere with the signaling pathways that promote cancer cell proliferation. This targeted approach is designed for tumors that express this particular genetic abnormality.
Selitrectinib is a distinct investigational drug and is not known to be the same as any other approved medication. It is being developed specifically for the treatment of solid tumors with NTRK fusion. No alternative names for this drug have been reported in the clinical trial data.