ARPA-H opens first interventional clinical trials to outpace cancer in real time

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ARPA-H opens first interventional clinical trials to outpace cancer in real time

Trials will continuously adjust cancer treatments to get ahead of each change in tumor response 

The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today announced the opening of the first of three adaptive oncology clinical trials, under its Advanced Analysis for Precision Cancer Therapy (ADAPT) program. The ADAPT trials pioneer a continuously adaptive approach to monitoring and treating cancers by integrating detailed biological data with real-time analytical insights to tailor therapy as tumors evolve. These trials mark a significant moment for ARPA-H, they are the first interventional clinical trials for the agency. 

Building on ADAPT’s goal to make cancer treatments more responsive and precise, these clinical trials will adjust treatments using a tumor’s changing signals to maximize therapy response while minimizing resistance. The trials will enroll adult patients with metastatic breast, lung, or colon cancer across more than 33 clinical sites in the United States. 

“These trials embody ADAPT’s mission: to harness dynamic information from tumors to deliver exactly the right treatment at the right moment for each patient,” said Andrea Bild, Ph.D., ADAPT Program Manager. “By linking biomarkers, predictive modeling, and new clinical trial frameworks, we aim to establish a paradigm in which treatment evolves with the disease-- not behind it.” By intervening as tumor changes are detected and continuously recalibrating therapy to each patient’s unique tumor, this approach seeks to reduce ineffective treatments and improve patient outcomes. 

“ARPA-H is here to make the impossible possible—to bring what once felt decades away into patients’ lives now. For anyone facing cancer, every day matters, and we have to be more relentless than the disease”, said ARPA-H Director Alicia Jackson, Ph.D.. “ADAPT brings the best science, data, and technology to help clinicians adjust treatment in real time as tumors change—so we can stay ahead of resistance instead of chasing it, and give patients and families the best chance to restore health and save lives.”  

The ADAPT program includes three coordinated, nationwide platform trials optimizing treatment strategies across metastatic cancers through serial collections of molecular and clinical data. The EVOLVE trial in breast cancer will optimize sequencing of endocrine, targeted, and combination therapies as resistance emerges. The ASCEND-CRC trial in colorectal cancer will use early “delta biomarkers” to determine whether patients should continue, intensify, or switch standard and targeted therapies, including biomarker-matched novel agents. The IMMUNO-BIOMAP trial in non-small cell lung cancer will track tumor evolution during immunotherapy and assign patients to biomarker-matched sub-trials targeting newly identified resistance mechanisms. 

To accelerate discovery and broaden impact, ADAPT will rapidly share de-identified clinical, molecular, and imaging data with the research community through a secure, cloud-based national platform managed by DNAnexus, enabling continuous learning across institutions and faster translation of insights into patient care. Enrollment is open for the EVOLVE study in ER+HER2- and triple negative breast cancer at the University of North Carolina Chapel Hill in Chapel Hill, NC and the IMMUNO-BIOMAP study in non-small cell lung cancer at the City of Hope Duarte, CA. Additional trial enrollment will follow soon at The University of Texas MD Anderson Cancer Center in Houston, TX. MD Anderson is leading the ASCEND-CRC study in colorectal cancer. 

Each trial expects to enroll over 500 patients and will continually measure changes in tumor biology and treatment response over six years. 

Individuals interested in learning more about trial participation should speak with their oncologist and can find additional eligibility information at: