Phase 1b/2 study of ERAS-007 combinations in advanced GI malignancies completes enrollment of 101 patients

This was a Phase 1b/2, open-label, multicenter platform study designed to evaluate ERAS-007 in combination with other cancer therapies in study participants with advanced gastrointestinal malignancies. The study enrolled 101 patients. The primary objectives were to evaluate the safety and tolerability of escalating doses of ERAS-007 in combination with other cancer therapies, to determine the Maximum Tolerated Dose and/or Recommended Dose of ERAS-007 in these combinations, to evaluate the antitumor activity of the combinations, and to evaluate the pharmacokinetic profiles of ERAS-007 and the other therapies when administered together. The study commenced on September 20, 2021, with a primary completion date of August 15, 2025. The study was structured to initially commence with dose escalation of ERAS-007 administered in combination with encorafenib and cetuximab in study participants with metastatic colorectal cancer harboring a BRAF V600E mutation. It also planned for dose escalation of ERAS-007 administered in combination with palbociclib in study participants with metastatic colorectal cancer harboring KRAS or NRAS mutations. The conditions studied were metastatic colorectal cancer and metastatic pancreatic ductal adenocarcinoma. The interventions studied were ERAS-007, encorafenib, cetuximab, and palbociclib. The primary outcomes measured were Dose Limiting Toxicities, Maximum Tolerated Dose, and Recommended Dose. The study status is listed as COMPLETED. The lead sponsor was Erasca, Inc. The abstract does not provide specific efficacy results, safety data, pharmacokinetic findings, or the determined MTD/RD.

For people with advanced colorectal or pancreatic cancer that has spread, treatment options can be limited. A recent study tested a new drug called ERAS-007, given alongside other established cancer drugs, to see if it could help. The goal was straightforward: find a dose that patients could tolerate and see if the combinations showed any promise against these aggressive cancers. The study involved 101 people and looked at two specific groups. For patients with a certain type of colorectal cancer (with a BRAF V600E mutation), ERAS-007 was tested with two drugs called encorafenib and cetuximab. For patients with colorectal cancer that has different mutations (KRAS or NRAS), ERAS-007 was tested with a drug called palbociclib. The main things the researchers were looking for were side effects serious enough to limit the dose, the highest dose patients could handle, and a recommended dose for future studies. They also checked how the drugs moved through the body when given together and looked for any early signs that the treatments might shrink tumors. This was an early-stage trial, meaning its primary job was to establish safety and dosing, not prove effectiveness. The findings from this study will help determine if these combinations are worth testing in larger groups of patients.