Phase 1 trial findings published in Nature Medicine show promise for a new approach to targeting colorectal cancer and other tumors expressing CEACAM5.
NEXT Oncology’s Dr. Ildefonso Ismael Rodriguez Rivera, a medical oncologist and hematologist in the San Antonio office, has led an innovative Phase 1 clinical trial of precemtabart tocentecan (Precem-TcT) focused on metastatic colorectal cancer, with results now published in Nature Medicine—one of the world’s most prestigious scientific journals—highlighting the promise of this novel therapy for patients who are no longer responding to other treatment options.
This innovative antibody drug conjugate (ADC) targets a protein called CEACAM5, which is found in high amounts on many colorectal cancer cells, with a topoisomerase 1 inhibitor, exatecan, as the payload that is delivered into the cancer cells. Pre-clinical data suggest that Precem-TcT can also exert a “bystander effect” that leads to the death of nearby cancer cells that may have low or no CEACAM5 expression.
Dr. Rodriguez Rivera serves as Principal Investigator and senior author of the Phase 1 PROCEADE-CRC-01 trial, conducted at NEXT Oncology – San Antonio and global partnering institutions in the US, Europe and Japan. In the published study findings, the initial 40 patients with heavily pretreated metastatic colorectal cancer were treated with Precem-TcT. The study aimed to evaluate safety, determine the maximum tolerated dose, and help guide dosing for future trials. Among the key findings:
- Among patients treated at a dose of 2.4 mg/kg or higher, an unconfirmed partial response rate of 17.6% was observed, disease control rate was 58.8% at week 12, and median progression-free survival was 6.7 months.
- The safety profile was manageable, with myelosuppression, specifically neutropenia and anemia, being the most common adverse events. There were few gastrointestinal side effects overall, and those that occurred were mild. No events of interstitial lung disease or ocular toxicity – observed in other ADCs – occurred.
The trial is listed under ClinicalTrials.gov Identifier: NCT05464030.
“As Principal Investigator, I’m encouraged by the activity we’ve seen with Precem-TcT, particularly in this patient population that has progressed through multiple lines of therapy including pretreatment with irinotecan,” said Dr. Rodriguez Rivera. “This trial highlights the promise of CEACAM5 as a therapeutic target and demonstrates NEXT Oncology’s continued leadership in partnering with companies innovating new therapies and providing best-in-class, first-in-human oncology research.”
Precemtabart tocentecan is being developed by Merck KGaA, Darmstadt, Germany, which operates its healthcare business as EMD Serono in the U.S. and Canada. Precem-TcT is currently being studied in several ongoing trials in patients with colorectal cancer and in patients with other CEACAM5-expressing tumors.
With locations in San Antonio, Austin, Dallas, and Houston, Texas; Arlington, Virginia; Barcelona and Madrid, Spain; and São Paulo, Brazil, NEXT Oncology has treated more than 1,000 patients per year—cementing its position as one of the leading Phase 1 clinical trial centers in the world.
About NEXT Oncology
NEXT Oncology is dedicated to the development of new anticancer agents for patients whose current cancer therapy is no longer working to benefit them and are looking for their next option. NEXT Oncology is partnered with Texas Oncology, the largest private oncology practice in the United States with more than 400 referring medical oncologists. Texas Oncology is a practice within The US Oncology Network, a network of independent, community-based oncologists in the U.S. This formidable size and reach provide NEXT Oncology unprecedented opportunities to transform what has come to be expected from clinical trials of new agents.