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BAY2287411 · 1 trial · 4 indications
| Arm | Type | Description |
|---|---|---|
| Dose escalation cohort a | EXPERIMENTAL | Subjects with either advanced recurrent epithelioid mesothelioma or serous ovarian cancer who have exhausted available therapeutic options. The dose of Thorium-227 will start at 1.5 MBq and increase in steps of 1.0 or 1.5 MBq, with antibody doses of 10 mg. |
| Dose escalation cohort b | EXPERIMENTAL | Subjects with either advanced recurrent epithelioid mesothelioma or serous ovarian cancer who have exhausted available therapeutic options. The dose of Thorium-227 will start at 1.5 MBq and increase in steps of 1.0 or 1.5 MBq, with a total antibody dose within the range of 10 - 50 mg. |
| Dose Expansion Cohort 1 | EXPERIMENTAL | Subjects with advanced recurrent epithelioid mesothelioma or serous ovarian cancer, who have exhausted available therapeutic options Dose / Regimen 1 (to be determined after completion of the dose escalation) |
| Dose Expansion Cohort 2 | EXPERIMENTAL | Subjects with advanced recurrent epithelioid mesothelioma or serous ovarian cancer, who have exhausted available therapeutic options Dose / Regimen 2 (to be determined after completion of the dose escalation) |
| Dose expansion Cohort 3 (optional) | EXPERIMENTAL | Subjects with histologically or cytologically confirmed unresectable, metastatic or locally advanced pancreatic ductal adenocarcinoma Dose / Regimen to be determined |
| Dose escalation cohort c | EXPERIMENTAL | Subjects with either advanced recurrent epithelioid mesothelioma or serous ovarian cancer who have exhausted available therapeutic options. The dose of Thorium-227 will start at 1.5 MBq and increase in steps of 1.0 or 1.5 MBq, with antibody doses of 10 - 150 mg mg. |
| Dose escalation cohort d | EXPERIMENTAL | Subjects with either advanced recurrent epithelioid mesothelioma or serous ovarian cancer who have exhausted available therapeutic options. The dose of Thorium-227 will start at 1.5 MBq and increase in steps of 1.0 or 1.5 MBq, with antibody doses of 10 - 400 mg. |
| Name | Type | Description |
|---|---|---|
| BAY2287411 | DRUG | Dose Escalation part: A single dose will be administered intravenously on Day 1 of each cycle lasting 6 weeks (42 days). |
Inclusion Criteria: * Signed informed consent * Male or female subjects ≥ 18 years of age * ECOG PS (Eastern Cooperative Oncology Group Performance Status) of 0 or 1 * Patients with advanced malignant epithelioid mesothelioma or advanced recurrent serous ovarian cancer, who have exhausted available...
BAY2287411 is an investigational small molecule being studied for advanced recurrent malignant pleural epithelioid mesothelioma. The Phase 1 trial also included patients with advanced recurrent malignant peritoneal epithelioid mesothelioma, advanced recurrent serous ovarian cancer, and advanced pancreatic ductal adenocarcinoma, though the pancreatic cohort was optional and not initiated.
BAY2287411 is a thorium-227 labeled antibody-chelator conjugate designed to target mesothelin, a protein expressed on tumor cells. The drug delivers thorium-227, a radioactive isotope, to mesothelin-expressing tumors to potentially damage their DNA and kill cancer cells.
BAY2287411 is being developed by Bayer AG, a German pharmaceutical company traded on the OTC market under the ticker BAYRY. The drug is in clinical development for oncology indications, specifically mesothelin-expressing tumors.
BAY2287411 is in Phase 1 clinical development. The first-in-human study, NCT03507452, has been completed. The drug is investigational and not yet approved by regulatory authorities. Its safety and efficacy are still being evaluated in clinical trials.
BAY2287411 has one completed Phase 1 trial, NCT03507452, titled 'First-in-human Study of BAY2287411 Injection, a Thorium-227 Labeled Antibody-chelator Conjugate, in Patients With Tumors Known to Express Mesothelin.' The study enrolled 36 participants across the United States, Finland, Netherlands, Sweden, and the United Kingdom.
Yes, BAY2287411 is a thorium-227 labeled antibody-chelator conjugate. This means it combines a mesothelin-targeting antibody with a chelator that holds thorium-227, a radioactive isotope, to deliver radiation specifically to tumor cells expressing mesothelin.