The Colorectal Cancer Alliance (Alliance) and the Global Coalition for Adaptive Research (GCAR) have announced a partnership to establish KLEOS, a landmark adaptive clinical trial platform aimed at accelerating the development of new therapies for Colorectal Cancer (CRC), one of the leading causes of cancer-related deaths in the United States.

Designed as an adaptive clinical trial platform, KLEOS will enable the simultaneous evaluation of multiple treatment approaches under a single master protocol. The innovative framework is expected to streamline clinical research, reduce development timelines and improve patient access to cutting-edge therapies, including novel combination treatments.

The initiative is being led through the Alliance’s Project Cure CRC programme and supported by a USD 7.5 million donation, including funding from the LR Foundation. The platform is intended to provide a more efficient and cost-effective alternative to traditional clinical trials by allowing new treatment arms to be added as therapies emerge and incorporating interim analyses for real-time decision-making.

According to the organisations, KLEOS is designed to generate high-quality clinical evidence while increasing flexibility in evaluating promising therapies. The adaptive model is expected to accelerate the identification of effective treatments and support more personalised care by matching patients with therapies based on evolving clinical data.

Dr. Meredith Buxton, CEO and President, GCAR, said the collaboration reflects a shared commitment to transforming clinical development through innovative and patient-centric research frameworks. She noted that the platform aims to reduce barriers to therapeutic development while creating new opportunities for evaluating novel treatment options.

Dr. John Marshall, Chief Medical Consultant at the Colorectal Cancer Alliance, Principal Investigator of KLEOS, and Director of the Ruesch Center for the Cure of Gastrointestinal Cancers at Georgetown University, highlighted the urgent need for better treatment options for late-stage colorectal cancer patients. He said the platform offers an opportunity to rigorously assess emerging therapies and potentially improve survival outcomes for patients facing limited treatment choices.

Michael Sapienza, CEO of the Colorectal Cancer Alliance, described KLEOS as a key pillar of Project Cure CRC, underscoring the organisation’s mission to accelerate research and deliver innovative therapies to patients faster. He added that GCAR’s expertise in designing collaborative clinical trials would help create a more responsive research model focused on patient needs.

The Alliance has also established the Project Cure CRC Consortium, a panel of leading colorectal cancer experts who will work to advance the KLEOS platform and support its development. The consortium is expected to play a central role in shaping future research strategies and therapeutic evaluations.

Through this collaboration, the Alliance and GCAR aim to create a next-generation clinical trial ecosystem capable of accelerating the discovery, testing, and delivery of more effective treatments for colorectal cancer patients worldwide.