Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Osimertinib (Osi)
Osimertinib · 1 trial · 1 indication
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
The RPTD of ABBV-399 when administered as monotherapy and in combination with osimertinib, erlotinib or nivolumab will be determined during the dose escalation phase of the study. RPTD will be determined using available safety and pharmacokinetics data.
AUC (0-t) = Area under the serum concentration versus time curve from time zero (pre-dose) to the time of the last measurable concentration.
Maximum observed plasma concentration (Cmax).
Time to Cmax (Tmax).
Terminal elimination half life.
| Arm | Type | Description |
|---|---|---|
| Monotherapy Telisotuzumab vedotin (21-day dosing cycles) | EXPERIMENTAL | Telisotuzumab vedotin will be administered at escalating dose levels in 21-day dosing cycles. Additional subjects will be enrolled in an expansion cohort that will further evaluate Telisotuzumab vedotin. |
| Monotherapy Telisotuzumab vedotin(28-day dosing cycles) | EXPERIMENTAL | Telisotuzumab vedotin will be administered at escalating dose levels in 28-day dosing cycles. Additional subjects will be enrolled in an expansion cohort that will further evaluate Telisotuzumab vedotin. |
| Monotherapy Expansion Cohort | EXPERIMENTAL | Telisotuzumab vedotin will be administered every 14 days on a 28-day dosing cycle. |
| Arm A (Telisotuzumab vedotin plus Erlotinib) | EXPERIMENTAL | Telisotuzumab vedotin to be evaluated with Erlotinib. |
| Arm D (Telisotuzumab vedotin plus Nivolumab) | EXPERIMENTAL | Telisotuzumab vedotin to be evaluated with Nivolumab. |
| Arm E (Telisotuzumab vedotin plus Osimertinib) | EXPERIMENTAL | Telisotuzumab vedotin to be evaluated with Osimertinib. |
| Name | Type | Description |
|---|---|---|
| Osimertinib | DRUG | It is administered orally everyday. |
| Nivolumab | DRUG | It is an intravenous infusion administered every 14 days. |
| Telisotuzumab vedotin | DRUG | It is administered by infusion in 21-day dosing cycles. |
| Erlotinib | DRUG | It is administered orally everyday. |
Inclusion Criteria: * Participant must have advanced Non-Small Cell Lung Cancer (NSCLC) that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit. * Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to...
Osimertinib is an investigational small molecule being studied for the treatment of advanced solid tumors cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in a clinical trial enrolling 237 participants across multiple countries.
Osimertinib targets the epidermal growth factor receptor (EGFR) and acts as an inhibitor of this target. By inhibiting EGFR, the drug is designed to interfere with signaling pathways that can drive tumor growth in advanced solid tumors. This mechanism is being investigated in early-stage clinical trials.
Osimertinib is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug in patients with advanced solid tumors.
Osimertinib is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is active but not recruiting participants, and the drug remains in early-stage clinical testing.
Osimertinib is being evaluated in a single Phase 1 clinical trial registered as NCT02099058. This study is assessing the safety, pharmacokinetics, and preliminary efficacy of the drug in participants with advanced solid tumors. The trial has enrolled 237 participants and is active but not recruiting.
Yes, Osimertinib is also known as Osi. This alternative name is used in clinical and research settings to refer to the same investigational drug. Patients and healthcare professionals may encounter either name when reviewing information about this Phase 1 oncology candidate.