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BAY3375968 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Dose escalation - Arm 1A | EXPERIMENTAL | Dose escalation of BAY3375968 as monotherapy |
| Dose escalation - Arm 1B | EXPERIMENTAL | Dose escalation of BAY 3375968 in combination with pembrolizumab |
| Dose expansion - Arm 2A | EXPERIMENTAL | BAY3375968 monotherapy-mode-of-action (monotherapy-MoA) expansion in subjects with one of the following tumor types: NSCLC, TNBC, HNSCC, or melanoma. The tumors should have primary (ICI-refractory) or secondary (ICI-relapsed) resistance to prior ICI-therapy. The final decision on the enrolled tumor type is at the discretion of the Sponsor. |
| Dose expansion - Arm 2B | EXPERIMENTAL | Disease-specific combination expansion with separate cohorts in ICI-relapsed tumor types (NSCLC, TNBC, HNSCC, gastric cancer, or melanoma) |
| Name | Type | Description |
|---|---|---|
| BAY3375968 | DRUG | Intravenous (IV) infusion |
| Pembrolizumab | DRUG | IV infusion |
Inclusion Criteria: * Capable of giving signed informed consent. * Has received, been intolerant to, or been ineligible for all treatment options proven to confer clinical benefit. * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. * Eastern Cooperative Oncology Gro...
| 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 |
BAY3375968 is an investigational anti-CCR8 antibody being studied for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development, where it is being evaluated alone and in combination with pembrolizumab to assess its safety, how it affects the body, and to determine the best dose.
BAY3375968 targets CCR8, a chemokine receptor. As an anti-CCR8 antibody, it is designed to bind to this receptor, which is expressed on certain immune cells. The drug is being investigated for its potential role in treating advanced solid tumors by modulating the immune response.
BAY3375968 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer is conducting a Phase 1 clinical trial to evaluate the drug's safety, tolerability, and pharmacokinetics in participants with advanced solid tumors.
BAY3375968 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is a first-in-human study designed to assess the drug's safety, how it moves through the body, and to identify the optimal dose.
BAY3375968 is being studied in a single Phase 1 clinical trial with the identifier NCT05537740. This first-in-human study is evaluating the drug alone and in combination with pembrolizumab in participants with advanced solid tumors. The trial is active but not recruiting, with an enrollment target of 129 participants.
No, BAY3375968 is not the same as pembrolizumab. BAY3375968 is an anti-CCR8 antibody developed by Bayer, while pembrolizumab is an anti-PD-1 antibody. In the clinical trial NCT05537740, BAY3375968 is being tested both alone and in combination with pembrolizumab to evaluate their combined effects.