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Also known as Lanerkitug (INN)
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 | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
BAY3375968 is an investigational therapy being studied for the treatment of advanced solid tumors. It is not approved for any indication and remains in clinical development. The Phase 1 trial enrolls adults with advanced solid tumors, including biomarker-selected patients, to evaluate safety and determine the best dose.
BAY3375968 targets CCR8, a receptor expressed on certain immune cells in the tumor microenvironment. By binding CCR8, the drug is designed to modulate immune activity against cancer cells. The Phase 1 study evaluates BAY3375968 alone and in combination with pembrolizumab in advanced solid tumors.
BAY3375968 is being developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer is the sole sponsor of the ongoing Phase 1 clinical trial for this asset.
BAY3375968 is in Phase 1 clinical development. It is an investigational small molecule and has not been approved by the FDA or any regulatory agency. The first-in-human study is currently active and not recruiting, with a planned enrollment of 129 participants.
BAY3375968 is being evaluated in a single Phase 1 trial, NCT05537740. This first-in-human study is testing the drug alone and in combination with pembrolizumab in participants with advanced solid tumors. The trial is active but not recruiting and is being conducted in the United States, Belgium, Canada, China, France, Singapore, Spain, and the United Kingdom.