Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY2965501 · 1 trial · 1 indication
If AUC(0-24) cannot be calculated reliably, it might become necessary to appoint the additional parameter AUC(0-tlast) as primary variable.
| Arm | Type | Description |
|---|---|---|
| Dose escalation of BAY2965501 | EXPERIMENTAL | For escalation part, different dose levels of BAY2965501 are planned. |
| Dose expansion of BAY2965501 | EXPERIMENTAL | For expansion part, specific tumor types are recruited: NSCLC (non-small cell lung cancer). |
| Dose escalation of BAY2965501+pembrolizumab | EXPERIMENTAL | For escalation part different dose levels of BAY2965501 are planned in combination with 200mg pembrolizumab. BAY2965501 will be taken in combination with 200mg pembrolizumab every 3 weeks. |
| Dose expansion of BAY2965501 +pembrolizumab | EXPERIMENTAL | For expansion part, specific tumor types are recruited (non-small cell lung cancer (NSCLC) and gastric/gastroesophageal junction (GEJ) adenocarcinoma). BAY2965501 will be taken in combination with 200mg pembrolizumab every 3 weeks. |
| Dose escalation of BAY 2965501 + pembrolizumab + platinum-based regimen | EXPERIMENTAL | The starting dose of BAY 2965501 with pembrolizumab for this combination will be no higher than one dose level below that shown to be safe in BAY 2965501 and pembrolizumab dose escalation. The doses of platinum-based regimen will be as per standard of care and given for a maximum of 6 cycles, in line with the current labeled dose. The dose of pembrolizumab will be 200 mg every 3 weeks, in line with the current labeled dose. |
| Dose expansion of BAY 2965501 + pembrolizumab + platinum-based regimen | EXPERIMENTAL | Participants with selected (to be decided by the sponsor) advanced solid tumors will be recruited in a dose expansion cohort of BAY 2965501 with pembrolizumab and platinum-based regimen. |
| Name | Type | Description |
|---|---|---|
| BAY2965501 | DRUG | Daily oral application |
| Pembrolizumab | DRUG | In combination group 200mg as infusion every 3 weeks |
| Platinum-based Chemotherapy | DRUG | Standard of care doses per tumor type will be administered. |
Inclusion Criteria: * Have measurable disease per Response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) as assessed by the local site investigator. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * Participants with histologically confirmed diagnosi...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
BAY2965501 is an investigational small molecule being studied for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being evaluated in patients with advanced solid tumors to assess its safety, tolerability, and potential anti-tumor activity.
BAY2965501 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded over-the-counter under the ticker symbol BAYRY. The company is conducting a first-in-human study of BAY2965501 in patients with advanced solid tumors.
BAY2965501 is in Phase 1 clinical development. The drug is being studied in a first-in-human trial that is currently active but not recruiting participants. BAY2965501 is an investigational agent and has not been approved by the FDA or other regulatory bodies for any indication.
BAY2965501 is being evaluated in a single Phase 1 clinical trial with the identifier NCT05614102. This first-in-human study is designed to assess the safety, tolerability, and pharmacokinetics of BAY2965501 as a single agent and in combination, and to determine the maximum tolerated dose in participants with advanced solid tumors.
The molecular target of BAY2965501 has not been disclosed in available information. As a small molecule, it is designed to interact with specific biological pathways involved in tumor growth, but the exact mechanism of action is not publicly detailed. The ongoing clinical trial aims to characterize its effects in patients with advanced solid tumors.
No, BAY2965501 is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials. The drug is being studied in patients with advanced solid tumors to evaluate its safety and efficacy, but it has not yet received marketing approval from the FDA or any other regulatory agency.