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ESMO 2025 | PROCEADE-CRC-01: updated clinical data of precem-TcT in pretreated mCRC
Ken Kato, MD, PhD, National Cancer Center Hospital East, Tokyo, Japan, comments on the Phase 1 PROCEADE-CRC-01 study (NCT05464030) evaluating precemtabart tocentecan (precem-TcT), an anti-CEACAM5 antibody–drug conjugate with an exatecan payload, in patients with heavily pretreated metastatic colorectal cancer (mCRC). Updated data show promising objective response rates and disease control, and efficacy was observed regardless of RAS/BRAF mutation or CEACAM5 expression. Safety was manageable, with predictable hematologic and gastrointestinal adverse events. This interview took place at the European Society for Medical Oncology (ESMO) 2025 Congress in Berlin, Germany.
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Transcript
PROCEADE-CRC-01 was already presented the ASCO meeting this year and last year for Professor Kopetz. precem-TcT is an anti-CEACAM5 ADC. It has a payload of the exact scan. After those findings in phase 1, those findings in phase 2 were conducted for colorectal cancer. The treatment cohort was divided into the 2.4 mg per kilogram and the 2.8 mg per kilogram. So we can see the toxicity mainly by the hematologic toxicity, of course, when lived by the exacerbation, most of these toxins were manageable...
PROCEADE-CRC-01 was already presented the ASCO meeting this year and last year for Professor Kopetz. precem-TcT is an anti-CEACAM5 ADC. It has a payload of the exact scan. After those findings in phase 1, those findings in phase 2 were conducted for colorectal cancer. The treatment cohort was divided into the 2.4 mg per kilogram and the 2.8 mg per kilogram. So we can see the toxicity mainly by the hematologic toxicity, of course, when lived by the exacerbation, most of these toxins were manageable. And so, no lung diseases, or for example, the hand-to-foot syndrome was observed. That is a different form of another drug of ADC. And we can manage that so hematologic toxicity to reduce by reducing the dose or adding the GCSF. And then so efficacy is very promising for the colorectal cancer. Most of the patients in these trials are receiving prior oxaliplatin. But around 20% of the patients respond to the precem-TcT. So next step, we proceed in the development for the second-line combination or first-line combination of the colorectal cancer.
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