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BAY94-9343 · 3 trials · 3 indications
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).
Q3W Arm: Cmax, AUC (0-504), AUC (0-tlast), tmax, t1/2 and AUC (Cycle 1 only) Q3W: Cycle 1 and Cycle 3: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, (24), 48, (96), 168, 336 and 504 hours after start of infusion QW Arm:Cmax, AUC(0-168) and tmax) QW: Cycle 1 and Cycle 3: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 24, 48 and 168 hours after start of infusion
| 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) |
| BAY94-9343 | EXPERIMENTAL | Cohort 1: Safety, tolerability and PK of 4.5 mg/kg dose given Q3W. Proceeding to Cohort 2 or not will be decided based on both safety variables during Cycle 1 (21 days) of 3 to 6 subjects in Cohort 1 and PK obtained from Cycle 1 (at least Day 1 to Day 5). Cohort 2: Safety, tolerability and PK of 6.5 mg/kg dose given Q3W. Whether recruitment will be continued up to 9 subjects for Cohort 2 or not will be decided based on safety variables during Cycle 1 (21 days) of the first 3 subjects in Cohort 2. The safety and tolerability of 6.5 mg/kg will be assessed based on the data of 9 subjects during Cycle 1 in Cohort 2, and considering long term toxicity, the safety and tolerability of BAY94-9343 will be assessed all safety data by the end of 3 cycles in Cohort 2. |
| BAY94-9343 (Dose-Escalation) | EXPERIMENTAL | BAY94-9343 was administered intravenously in this study. The starting dose for this first-in-man study was 0.15 mg/kg administered as a 1 hour infusion every 21 days. (ENROLLMENT CLOSED). |
| BAY94-9343 (Expansion) | EXPERIMENTAL | After Maximum tolerated dose (MTD) had been defined, expansion cohorts were conducted at the MTD dose. Overall up to 32 subjects were planned to be enrolled in the expansion cohort: * Ovarian Carcinoma, 20 subjects * Mesothelioma, 6-12 subjects (ENROLLMENT CLOSED). |
| BAY94-9343 (1.8 mg/kg) | EXPERIMENTAL | This part of study was randomized and open-label. BAY94-9343 in two parallel dose cohorts of twenty (20) patients with recurrent platinum-resistant or platinum partially-sensitive ovarian cancer and up to four (4) patients with advanced malignant epithelioid peritoneal mesothelioma and eight (8) patients with advanced pleural mesothelioma. |
| BAY94-9343 (2.2 mg/kg) | EXPERIMENTAL | This part of study was randomized and open-label. BAY94-9343 in two parallel dose cohorts of twenty (20) patients with recurrent platinum-resistant or platinum partially-sensitive ovarian cancer and up to four (4) patients with advanced malignant epithelioid peritoneal mesothelioma and eight (8) patients with advanced pleural mesothelioma. |
| 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 |
| BAY94-9343 | DRUG | Cohort 1: 4.5 mg/kg of BAY 94-9343 at Q3W dose regimen. Cohort 2: 6.5 mg/kg of BAY 94-9343 at Q3W dose regimen. |
| BAY94-9343 (Expansion) | DRUG | BAY94-9343 was administered intravenously in this study. The dose for this expansion cohort was 5.5mg/kg administered as a 1 hour infusion every 21 days. |
| BAY94-9343 (1.8 mg/kg) | DRUG | BAY94-9343 was administered intravenously in this study. The dose for this cohort was 1.8 mg/kg administered as a 1 hour infusion every week for 3 weeks. |
| BAY94-9343 (2.2 mg/kg) | DRUG | BAY94-9343 was administered intravenously in this study. The dose for this cohort was 2.2 mg/kg administered as a 1 hour infusion every week for 3 weeks. |
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...
BAY94-9343 is an investigational small molecule developed by Bayer AG for oncology indications, including medical oncology and neoplasms. It has been studied in Phase 1 clinical trials in patients with advanced solid tumors. It is not an approved therapy and remains in clinical development.
BAY94-9343 has been studied for the treatment of advanced solid tumors and other malignancies in oncology. Clinical testing focused on patients with mesothelin-expressing solid tumors and advanced cancers. It is investigational and has not been approved for any indication.
Bayer AG develops BAY94-9343. Bayer trades on the OTC market under the ticker BAYRY. The company sponsored the Phase 1 clinical program evaluating the agent in patients with advanced solid tumors and other malignancies across sites in the United States, Italy, and Japan.
BAY94-9343 is in Phase 1 development. All three of its listed clinical trials are Phase 1 studies, and all have completed. The drug is investigational and has not received FDA approval for any indication.
BAY94-9343 has been evaluated in three completed Phase 1 trials: NCT01439152, a dose-finding study in advanced solid tumors with 148 patients; NCT02639091, a Phase 1b study combining it with pemetrexed and cisplatin in mesothelin-expressing solid tumors; and NCT02485119, a dose escalation study in Japanese patients with advanced malignancies.
Yes, BAY94-9343 and BAY 94-9343 refer to the same investigational oncology compound from Bayer AG. The two spellings differ only by a space in the alphanumeric code, and both appear in references to the same Phase 1 clinical program in advanced solid tumors.