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Also known as Precemtabart tocentecan
M9140 · 4 trials · 7 indications
| Arm | Type | Description |
|---|---|---|
| Arm 1: Precemtabart tocentecan (Precem-TcT) Monotherapy | EXPERIMENTAL | - |
| Arm 2: Precem-TcT plus Bevacizumab | EXPERIMENTAL | - |
| Arm 3: Trifluridine/Tipiracil (FTD-TPI) plus Bevacizumab | ACTIVE_COMPARATOR | - |
| Substudy GC: M9140 Monotherapy - Part A CEACAM5 High | EXPERIMENTAL | - |
| Substudy GC: M9140 Monotherapy - Part B CEACAM5 Low | EXPERIMENTAL | - |
| Substudy NSCLC: M9140 Monotherapy - Part A CEACAM5 High EGFR Wt | EXPERIMENTAL | - |
| Substudy NSCLC: M9140 Monotherapy - Part B CEACAM5 High EGFR mut | EXPERIMENTAL | - |
| Substudy PDAC: M9140 Monotherapy - Part A CEACAM5 High | EXPERIMENTAL | - |
| M9140 | EXPERIMENTAL | - |
| Part 1: M9140 | EXPERIMENTAL | - |
| Part 2A: M9140 | EXPERIMENTAL | - |
| Part 2B: M9140 | EXPERIMENTAL | - |
| Part 2C: M9140 + Bevacizumab +/-Capecitabine | EXPERIMENTAL | - |
| Part 2D: M9140 + 5-fluorouracil + Folinic acid + Bevacizumab | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Precemtabart tocentecan | DRUG | Precem-TcT, administered, once every 3 weeks intravenously, on Day 1 of each 21-day cycle. |
| Bevacizumab | DRUG | Bevacizumab, administered intravenously every 3 weeks on Day 1 of each 21-day cycle or every 2 weeks on Day 1 and Day 15 of each 28-day cycle. |
| Trifluridine/Tipiracil (FTD-TPI) | DRUG | FTD-TPI, tablet, administered orally twice daily, on Days 1 to 5 and Days 8 to 12 of each 28-day cycle. |
| M9140 | DRUG | All participants will receive 2.8 milligram per kilogram (mg/kg) M9140 intravenously (i.v.) every 3 weeks (q3w) on Day 1 of consecutive 21-day cycles. |
| Capecitabine | DRUG | Capecitabine will be administered orally as per standard of care. |
| 5-fluorouracil (5-FU) | DRUG | 5-FU will be administered intravenously as per standard of care. |
| Folinic acid | DRUG | Folinic acid will be administered intravenously as per standard of care. |
Inclusion Criteria: * Participants with documented histopathological diagnosis of metastatic colorectal cancer, who were intolerant to, or whose disease was refractory to, or progressed after standard systemic therapies and no more than 2 previous systemic treatment regimens in the metastatic setti...
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M9140 is an investigational small molecule oncology drug being developed by Merck KGaA for the treatment of colorectal cancer and other advanced solid tumors. It is in Phase 1 clinical development and has not been approved for any indication. M9140 is being studied in patients with colorectal cancer, gastric cancer, non-small cell lung cancer, pancreatic cancer, and pancreatic ductal adenocarcinoma.
M9140 is being studied for the treatment of colorectal cancer and other advanced solid tumors, including gastric cancer, non-small cell lung cancer, pancreatic cancer, and pancreatic ductal adenocarcinoma. It is an investigational therapy in Phase 1 clinical development and is not approved for any use. All studies enroll adults aged 18 years and older.
M9140 is being developed by Merck KGaA, which trades under the ticker MKGAF. The company is running the clinical development program for M9140 across multiple countries, including the United States, China, Japan, South Korea, Spain, France, Germany, Italy, Austria, Canada, and Australia.
M9140 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. Two Phase 1 trials are currently active, and no trials have been completed. The studies are enrolling or have enrolled adults with advanced solid tumors, including colorectal cancer.
M9140 is being evaluated in Phase 1 trials including NCT05464030 (PROCEADE-CRC-01) in colorectal cancer, NCT06710132 (PROCEADE PanTumor) in advanced solid tumors, and NCT06806046 in Chinese participants with solid tumors and colorectal cancer. All three studies are active but not recruiting, and they include sites across North America, Europe, and Asia.
The M9140 clinical program has a total planned enrollment of 220 patients across its trials. The PROCEADE-CRC-01 study (NCT05464030) accounts for 220 participants, the PROCEADE PanTumor study (NCT06710132) enrolled 184, and the Chinese solid tumor study (NCT06806046) enrolled 12. All trials are Phase 1 and enroll adults aged 18 and older.