Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY 94-9343 · 1 trial · 1 indication
MTD is defined as the highest dose of oral anetumab ravtansine (BAY 94-9343) administered in combination with IV pemetrexed and cisplatin that can be given such that not more than 1 of 6 subjects at a given dose level experience a DLT (dose-limiting toxicity).
| Arm | Type | Description |
|---|---|---|
| BAY 94-9343 + Pemetrexed + Cisplatin | EXPERIMENTAL | Investigating the combination of anetumab ravtansine (BAY 94-9343) with Pemetrexed (500 mg/m2) and Cisplatin (75 mg/m2) in Part 1 (dose escalation cohorts) and Part 2 (two MTD expansion cohorts) |
| Name | Type | Description |
|---|---|---|
| BAY 94-9343 | DRUG | In Part 1 of the study, anetumab ravtansine (BAY 94-9343) will be administered by 1-hour IV infusion with a starting dose of 5.5mg/kg(BW) on Day 1 of every treatment cycle (Q3W). In Part 2 of the study, anetumab ravtansine (BAY 94-9343) will be administered on Day 2 of Cycle 1 and then on Day 1 of Cycle 2 and all subsequent cycles (Q3W) |
| Pemetrexed | DRUG | Administered at the dose of 500 mg/m2 body surface area (BSA) by 10-minute IV infusion on Day 1 of every treatment cycle (Q3W) in both parts of the study |
| Cisplatin | DRUG | Administered at the dose of 75 mg/m2 (BSA) by 2-hour IV infusion on Day 1 of every treatment cycle (Q3W) in both parts of the study |
Inclusion Criteria: * Subjects may be male or female, and must be aged =/\>18 years on the date of signing the informed consent form. * Subjects must have histologically confirmed, unresectable, locally advanced or metastatic pleural or peritoneal predominantly (\>50% of tumor component) epithelial...
BAY 94-9343 is an investigational small molecule being studied for the treatment of oncology conditions, including advanced solid tumors and other malignancies. It is in Phase 1 clinical development, with trials conducted in patients with various types of cancer. The drug is not yet approved and remains under investigation.
BAY 94-9343 is being developed by Bayer AG, a pharmaceutical company. Bayer is conducting clinical trials to evaluate the drug's safety and tolerability in patients with advanced solid tumors and other malignancies.
BAY 94-9343 is in Phase 1 clinical development. Multiple Phase 1 trials have been completed, including dose escalation studies in patients with advanced solid tumors and in Japanese subjects with advanced malignancies. The drug is investigational and not yet approved.
BAY 94-9343 has been studied in several completed Phase 1 trials. NCT01439152 evaluated the maximum tolerable dose in patients with advanced solid tumors. NCT02485119 was a dose escalation study in Japanese subjects with advanced malignancies. NCT02639091 tested the drug in combination with pemetrexed and cisplatin in mesothelin-expressing solid tumors.
Yes, BAY 94-9343 is also known as anetumab ravtansine. Clinical trial NCT02639091 refers to the drug as anetumab ravtansine, confirming that these names refer to the same investigational agent being developed by Bayer.