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Also known as Precem-TcT, M9140
Precemtabart tocentecan · 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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Precemtabart tocentecan is an investigational small molecule oncology drug being developed by Merck KGaA for the treatment of metastatic colorectal cancer. It is currently in Phase 3 clinical development and has not been approved by the FDA. It is being studied in patients with previously treated metastatic colorectal cancer.
Precemtabart tocentecan is being developed for the treatment of metastatic colorectal cancer. Specifically, it is under investigation for patients with previously treated metastatic colorectal cancer. It is not yet approved for any indication and remains an investigational therapy in Phase 3 clinical testing.
Precemtabart tocentecan is being developed by Merck KGaA, which trades under the ticker MKGAF. Merck KGaA is the sponsor of the ongoing Phase 3 clinical trial evaluating the drug in metastatic colorectal cancer.
Precemtabart tocentecan is in Phase 3 clinical development. The drug is being evaluated in a single active Phase 3 trial that is currently recruiting participants. It has not completed any trials and is not FDA approved.
Precemtabart tocentecan is being studied in one active Phase 3 trial, NCT07549412, titled PROCEADE-CRC-03. The trial is recruiting approximately 1,020 participants with previously treated metastatic colorectal cancer across multiple countries. It compares Precemtabart tocentecan with or without bevacizumab against trifluridine/tipiracil plus bevacizumab.