The Colorectal Cancer Alliance and the Global Coalition for Adaptive Research (GCAR) have announced a strategic collaboration to establish KLEOS, an adaptive clinical trial platform in colorectal cancer (CRC), the deadliest cancer in people under 50 and the second leading cause of cancer death overall in the US.
The KLEOS trial platform will employ an efficient and cost-effective study design intended to accelerate the evaluation of promising therapies – including novel combination approaches – while broadening patient access to cutting-edge treatment options and generating high-quality data to inform rapid clinical decision-making. KLEOS is Greek for “glory” and refers to a person’s legacy, honouring those we have lost to CRC and underscoring the need for this project. Through the collaboration, the organisations will accelerate clinical development to bring more effective therapies to patients with CRC faster.
The study is designed as an adaptive trial platform, which will enable the simultaneous evaluation of multiple therapies under a single, overarching trial protocol. Led by the Alliance’s Project Cure CRC initiative and supported by a $7.5m donation, in part by the LR Foundation, KLEOS will accelerate research toward cures. The LR Foundation is committed to supporting projects that combine technology and philanthropy to create critical efficiencies and advancements on a global scale.
Key features of KLEOS include an adaptive design that enables rapid evaluation of novel therapies or combinations, addition of new treatment arms as novel therapies emerge, and incorporation of interim analyses to inform real-time decision-making. Compared with traditional randomised clinical trials, this approach offers a more flexible and efficient pathway for evaluating novel therapies—accelerating timelines, optimising resource use, and increasing the likelihood of identifying effective treatments for patients.
This is designed to deliver benefits across the clinical research ecosystem. For patients, it expands access to innovative therapies, accelerates the pace at which new treatments can be evaluated, and enables a more personalised approach by matching patients to therapies based on evolving data. For drug developers, the platform offers a more efficient and cost-effective pathway to evaluate assets, supporting faster, data-driven decision-making. By leveraging shared infrastructure and continuous learning, the model has the potential to generate high-quality clinical evidence more rapidly than traditional approaches, ultimately helping bring effective new therapies to patients sooner.
“At GCAR, we believe the future of clinical development depends on innovative, efficient, and integrated frameworks,” said Meredith Buxton, CEO and president of GCAR.
“In close collaboration with the Alliance, the clinical community and pharmaceutical partners, we are building an adaptive, cost-effective trial platform designed to accelerate therapeutic development, reduce barriers, and create new opportunities to evaluate novel assets in a more responsive and patient-centred way. Our effort is rooted in the Alliance’s vision and mission and our shared commitment to improving outcomes for people living with CRC.”
“We simply cannot accept that late-stage CRC patients have a 13% five-year survival rate, and that is what drives everything we do,” said John Marshall, chief medical consultant, Colorectal Cancer Alliance, principal investigator of KLEOS and director of the Ruesch Center for the Cure of Gastrointestinal Cancers at Georgetown University.
“The KLEOS trial platform represents an opportunity to rigorously evaluate novel therapeutic approaches and generate the evidence base that could meaningfully extend and improve lives for patients who today have far too few options. That is the urgency behind this innovative trial platform that aims to accelerate cures, and why it matters so profoundly to the entire CRC community.”
“For patients and families, time matters,” said Michael Sapienza, CEO of the Colorectal Cancer Alliance.
“This trial represents a key pillar of Project Cure CRC and our commitment to accelerating research and facilitating the delivery of new treatment options faster. We are delighted to collaborate with GCAR, an organization with expertise in designing and operationalizing innovative, collaborative trials, to create a more responsive clinical trial model that prioritizes both speed and patient need.”
The Alliance has established a distinguished panel of CRC experts – the Project Cure CRC Consortium – who will convene at the American Society of Clinical Oncology Annual Meeting to advance the vision of the KLEOS adaptive clinical trial platform.