Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY94-9343 · 2 trials · 2 indications
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 |
|---|---|---|
| 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 |
|---|---|---|
| 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: * Japanese subjects ≥ 20 years of age * ECOG Performance Status of 0 to 1 * Life expectancy of at least 12 weeks * Subjects with advanced, histologically or cytologically confirmed solid tumors, not amenable to any standard therapy, have no standard therapy available * Subjects ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 5 | PHASE3 | ACE-536 |
| AbbVie, Inc. | ABBV | 4 | PHASE3 | Navitoclax, Ruxolitinib |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | Pelabresib, Ruxolitinib |
| Karyopharm Therapeutics, Inc. | KPTI | 4 | PHASE3 | Selinexor, Ruxolitinib |
| Geron Corporation | GERN | 2 | PHASE3 | Imetelstat |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Bomedemstat |
| Incyte Corporation | INCY | 10 | PHASE2 | Ruxolitinib |
| GSK plc Sponsored ADR | GSK | 2 | PHASE2 | MMB |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE2 | Elritercept, Ruxolitinib |
| Eli Lilly and Company | LLY | 1 | PHASE1 | LY3410738, Venetoclax, Azacitidine |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-0974 |
| Galecto, Inc. | GLTO | 1 | PHASE2 | GB2064 |
| Prelude Therapeutics, Inc. | PRLD | 1 | PHASE1 | PRT12396 |
| United Therapeutics Corporation | UTHR | 1 | PHASE2 | bomedemstat |
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.