Dr Hecht on Barriers to Enrollment into the BASECAMP-1 Study in Solid Tumors

J. Randolph (Randy) Hecht, MD, professor, clinical medicine, David Geffen School of Medicine, University of California, Los Angeles (UCLA), director, UCLA Gastrointestinal Oncology Program, discusses barriers to enrollment in the observational BASECAMP-1 study (NCT04981119) and the phase 1/2 EVEREST-1 study (NCT05736731), which will investigate HLA-A*02 as a target for the novel CAR T-cell therapy A2B530 in patients with solid tumors.

When embarking on new clinical research endeavors, disseminating information takes time, Hecht begins. Initially, only a minority of patients meet the eligibility criteria for enrollment in certain studies, and at various stages, patients are excluded. For instance, Hecht highlights that many patients do not qualify for clinical trials because of factors such as having multiple cancers or being elderly. This issue is exemplified in a case Hecht encountered where a patient was preparing for cancer-unrelated dialysis, which rendered them ineligible for clinical trial enrollment.

This initial reduction in eligibility for BASECAMP-1 and EVEREST-1 is compounded by the fact that only 40% of patients in North America possess the HLA-A*02 marker, a percentage which varies across different ethnicities, he notes. However, HLA-A*02 is found in all ethnic groups, albeit with some regional variability, Hecht says.

Another challenge lies in spreading awareness about these trials. Informing a patient about a currently available trial is considerably more straightforward than explaining that they are being screened for a trial that may open in the future, Hecht expands. This isn't an isolated issue, and institutions have collectively grappled with finding efficient patient education strategies, he emphasizes, adding that investigators are commencing efforts and exchanging insights to establish best practices across institutions.

Furthermore, a growing number of patients undergo next-generation sequencing (NGS), Hecht continues, adding that all patients with metastatic disease should receive NGS. Often, initial tumor profiling occurs before disease metastasis, particularly in colorectal, pancreatic, and lung cancers, shedding light on genetic culprits such as RAS in lung cancer or BRCA in pancreatic cancer, Hecht says. NGS offers valuable insights beyond these usual suspects, and as NGS technology advances, it will enable more precise identification of HLA types, Hecht concludes.