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DRUG:

precemtabart tocentecan (M9140)

i
Other names: M9140, M-9140, M 9140, Precem-TcT
Associations
Company:
EMD Serono
Drug class:
Topoisomerase I inhibitor, CEACAM5-targeted antibody-drug conjugate
Related drugs:
Associations
4ms
Precemtabart tocentecan, an anti-CEACAM5 antibody-drug conjugate, in metastatic colorectal cancer: a phase 1 trial. (PubMed, Nat Med)
Precemtabart tocentecan (Precem-TcT, previously M9140) is an anti-CEACAM5 antibody-drug conjugate with the topoisomerase 1 inhibitor exatecan as payload...In the dose-escalation stage of the phase 1 trial of Precem-TcT (PROCEADE-CRC-01), 40 heavily pretreated patients with irinotecan-refractory metastatic CRC received Precem-TcT every 3 weeks across seven dose levels (DLs, 0.6-3.2 mg kg-1)...The dose-optimization part at the RDEs of 2.4 mg kg-1 and 2.8 mg kg-1 (both every 3 weeks) in PROCEADE-CRC-01 is ongoing. ClinicalTrials.gov identifier: NCT05464030 .
P1 data • Journal
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CEACAM5 (CEA Cell Adhesion Molecule 5)
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irinotecan • precemtabart tocentecan (M9140)
4ms
Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01) (clinicaltrials.gov)
P1, N=200, Recruiting, EMD Serono Research & Development Institute, Inc. | Trial completion date: Feb 2026 --> Aug 2026 | Trial primary completion date: Feb 2026 --> Aug 2026
Trial completion date • Trial primary completion date
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MSI (Microsatellite instability)
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MSI-H/dMMR
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Avastin (bevacizumab) • 5-fluorouracil • capecitabine • leucovorin calcium • precemtabart tocentecan (M9140)
5ms
Anti-CEACAM5 ADC M9140 in Chinese Participants With Solid Tumors (PROCEADE-CRC-02) (clinicaltrials.gov)
P1, N=24, Recruiting, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Trial completion date: Aug 2026 --> May 2026
Trial completion date
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precemtabart tocentecan (M9140)
5ms
Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor) (clinicaltrials.gov)
P1/2, N=250, Recruiting, EMD Serono Research & Development Institute, Inc. | Trial completion date: Jan 2029 --> Jan 2028 | Trial primary completion date: Jan 2029 --> Jan 2028
Trial completion date • Trial primary completion date • Pan tumor
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precemtabart tocentecan (M9140)
10ms
Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor) (clinicaltrials.gov)
P1/2, N=250, Recruiting, EMD Serono Research & Development Institute, Inc. | Not yet recruiting --> Recruiting
Enrollment open
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precemtabart tocentecan (M9140)
10ms
Anti-CEACAM5 ADC M9140 in Chinese Participants With Solid Tumors (PROCEADE-CRC-02) (clinicaltrials.gov)
P1, N=24, Recruiting, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
New P1 trial
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precemtabart tocentecan (M9140)
1year
Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor) (clinicaltrials.gov)
P1/2, N=250, Not yet recruiting, EMD Serono Research & Development Institute, Inc.
New P1/2 trial • Pan tumor • Metastases
|
precemtabart tocentecan (M9140)
over1year
Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (clinicaltrials.gov)
P1, N=180, Recruiting, EMD Serono Research & Development Institute, Inc. | Trial completion date: May 2025 --> Feb 2026 | Trial primary completion date: Apr 2024 --> Feb 2026
Trial completion date • Trial primary completion date • Metastases
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MSI (Microsatellite instability)
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MSI-H/dMMR
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Avastin (bevacizumab) • capecitabine • precemtabart tocentecan (M9140)
almost2years
Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (clinicaltrials.gov)
P1, N=180, Recruiting, EMD Serono Research & Development Institute, Inc. | N=31 --> 180 | Trial completion date: Nov 2023 --> May 2025 | Trial primary completion date: Nov 2023 --> Apr 2024
Enrollment change • Trial completion date • Trial primary completion date • Metastases
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MSI (Microsatellite instability)
|
MSI-H/dMMR
|
Avastin (bevacizumab) • capecitabine • precemtabart tocentecan (M9140)
over3years
Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (clinicaltrials.gov)
P1, N=30, Recruiting, EMD Serono Research & Development Institute, Inc.
New P1 trial
|
MSI (Microsatellite instability)
|
MSI-H/dMMR
|
precemtabart tocentecan (M9140)