The Lustgarten Foundation and Break Through Cancer Announce New Clinical Trial Evaluating KRAS-Targeted Immunotherapy Strategy for Pancreatic Cancer

Newly recruiting Phase 1 study will evaluate a next-generation KRAS-targeted immunotherapy, revealing how pancreatic tumor microenvironment shapes treatment response

The Lustgarten Foundation and Break Through Cancer today announced the launch of a new Phase 1 clinical trial evaluating a next-generation KRAS-targeted lymph-node stimulating immunotherapy strategy for pancreatic cancer. The study is now recruiting patients with pancreatic ductal adenocarcinoma (PDAC), representing a significant milestone for the organizations’ Demystifying Pancreatic Cancer Therapies TeamLab.

Led by Kevin Soares, MD, and Eileen O’Reilly, MD, Memorial Sloan Kettering Cancer Center, the multi-institutional study will evaluate the investigational therapy ELI-002 7P, from Elicio Therapeutics, Inc., in combination with standard neoadjuvant mFOLFIRINOX chemotherapy, with or without the PD-1 inhibitor tislelizumab. Researchers will examine not only the safety and feasibility of the approach but also generate detailed molecular and immune data from patient samples collected before and after treatment, helping researchers better understand how pancreatic tumors respond to therapy.

“At Lustgarten, we believe the fastest path to better treatments is through bold science and meaningful collaboration,” said Andrew Rakeman, VP of the Lustgarten Foundation. “This trial combines innovative immunotherapy with comprehensive analyses of the tumor microenvironment, allowing researchers to learn far more than whether the treatment is safe or effective. By understanding the biological mechanisms driving response and resistance, we can develop better therapies faster.”

The trial is one of the first clinical studies to emerge from the Demystifying Pancreatic Cancer Therapies TeamLab, a collaborative model led by Break Through Cancer and supported by the Lustgarten Foundation. The TeamLab unites investigators from six leading cancer centers — Dana-Farber Cancer Institute, Memorial Sloan Kettering Cancer Center, MIT’s Koch Institute for Integrative Cancer Research, the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, The University of Texas MD Anderson Cancer Center, and NYU Langone Health Perlmutter Cancer Center — to explore promising ideas and combine cutting-edge technologies. Together, the team is working to uncover why therapies succeed or fail, identify biomarkers of response and resistance, better understand the pancreatic tumor microenvironment, and accelerate the development of more effective treatment strategies for patients with pancreatic cancer.

“Clinical trials should do more than test new therapies, they should help us understand the biology of the disease itself,” said Tyler Jacks, PhD, president of Break Through Cancer. “By combining expertise across institutions, this study is designed to generate insights that can shape not only this therapeutic approach, but those that follow.”

The study also builds on encouraging results from a Phase 1 clinical trial published in Nature Medicine in 2025. In that study, an earlier version of the investigational KRAS-targeted immunotherapy generated robust immune responses in patients following surgery and chemotherapy. This next-generation trial moves ELI-002 7P into the earlier neoadjuvant setting, evaluating whether combining it with chemotherapy, with or without checkpoint immunotherapy, can generate stronger anti-tumor immune responses while potentially providing insight into how pancreatic tumors and their surrounding microenvironment respond to treatment.

The randomized Phase 1 trial aims to enroll 20 patients with resectable or borderline resectable KRAS-mutant pancreatic cancer. Participants will receive ELI-002 7P with standard chemotherapy, with or without tislelizumab, before surgery. Throughout treatment, researchers will collect tumor tissue and blood samples to better understand immune activation, characterize changes within the tumor microenvironment, and identify biomarkers that could guide future clinical trials.

The study is currently recruiting patients at Memorial Sloan Kettering Cancer Center locations throughout New York and New Jersey, with Dana-Farber Cancer Institute, the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, and UT MD Anderson Cancer Center opening as subsites in the coming months. Patients and physicians interested in learning more about eligibility or participating in the trial can visit the study listing on the ClinicalTrials.gov study listing.