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.
Can a new drug combination help people with advanced colorectal or pancreatic cancer?
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What this means for you:
An early trial tested new drug combos for advanced GI cancers to find safe doses. What this means for you:
An early trial tested new drug combos for advanced GI cancers to find safe doses. View Original Abstract ↓
Status: COMPLETED | Phase: PHASE1/PHASE2
Condition(s): Metastatic Colorectal Cancer, Metastatic Pancreatic Ductal Adenocarcinoma
Intervention(s): ERAS-007 (DRUG), Encorafenib (DRUG), Cetuximab (DRUG), Palbociclib (DRUG)
* To evaluate the safety and tolerability of escalating doses of ERAS-007 in combination with other cancer therapies in study participants with advanced GI malignancies.
* To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of ERAS-007 administered in combination with other cancer therapies.
* To evaluate the antitumor activity of ERAS-007 in combination with other cancer therapies.
* To evaluate the PK profiles of ERAS-007 and other cancer therapies when administered in combination.
Detailed: This is a Phase 1b/2, open-label, multicenter clinical study evaluating ERAS-007 in combination with other cancer therapies in study participants with GI malignancies. This study will serve as a platform study, allowing for evaluation of safety/tolerability and efficacy of ERAS-007 in combination with other cancer therapies. The study will initially commence with dose escalation of ERAS-007 administered in combination with encorafenib and cetuximab in study participants with metastatic colorectal cancer (CRC) harboring B-Raf proto-oncogene, serine/threonine kinase (BRAF) V600E mutation; and dose escalation of ERAS-007 administered in combination with palbociclib in study participants with metastatic CRC harboring Kirsten rat sarcoma (KRAS) or neuroblastoma rat sarcoma (NRAS) mutations and
Primary Outcome(s): Dose Limiting Toxicities (DLT); Maximum Tolerated Dose (MTD); Recommended Dose (RD)
Enrollment: 101 (ACTUAL)
Lead Sponsor: Erasca, Inc.
Start: 2021-09-20 | Primary Completion: 2025-08-15