The first step in making a new drug available to the general public is conducting a rigorous series of clinical trials involving volunteers to evaluate the safety and effectiveness of the investigational therapy.
Each trial is supervised, monitored and documented. Data from these clinical trials ultimately could support approval by regulatory agencies (such as the Food and Drug Administration in the United States), allowing a new therapy to become available for the benefit of many patients with cancer.
Clinical trial volunteers play a critical role in this process and we sincerely thank all of you patient heroes, as well as your supportive family and friends, for your participation in our clinical trials to make this journey possible.
SEACRAFT-1 (ERAS-254-01)
SEACRAFT-2 (ERAS-254-02)
SEACRAFT-3 (ERAS-254-03)
In any nautical journey, seacraft are needed to traverse the vast blue ocean not just in their capacity as seagoing ships, but also for their important second meaning: skill in navigation. Erasca is navigating the “blue ocean” of unmet medical needs using next generation sequencing and other techniques to identify RAS/MAPK pathway-altered tumors that can be treated with naporafenib, a potent, selective, orally bioavailable pan-RAF inhibitor, in combination with other targeted therapies. The SEACRAFT series of trials, beginning with SEACRAFT-1, SEACRAFT-2, and SEACRAFT-3, will test whether naporafenib can improve outcomes in NRASm melanoma, pan-RAS Q61X solid tumors, & other RAS/MAPK-driven tumors, respectively.
HERKULES-1 (ERAS-007-01): A Study to Evaluate ERAS-007 in Patients with Advanced or Metastatic Solid Tumors
ClinicalTrials.gov Study Identifier NCT04866134
HERKULES-2 (ERAS-007–02): A Study to Evaluate ERAS-007 in Combination with Other Anti-Cancer Therapies in Patients with Advanced Non-Small-Cell Lung Cancer
ClinicalTrials.gov Study Identifier NCT04959981
HERKULES-3 (ERAS-007-03): A Study of ERAS-007 in Patients With Advanced Gastrointestinal Malignancies
ClinicalTrials.gov Study Identifier NCT05039177
Hercules is one of the most iconic figures in classical mythology and one of the greatest adventurers of all time. He is best recognized for his extraordinary feats of strength and durability, attributes that would be desirable for cancer treatments, as well. ERAS-007 is an investigational therapy that has exhibited similar characteristics when administered in specific clinical trial participants diagnosed with certain cancers that are caused by abnormal RAS/MAPK pathway signaling. The HERKULES series of trials, beginning with HERKULES-1, HERKULES-2, and HERKULES-3, will continue to test the safety and effectiveness of ERAS-007 in trial participants with various solid tumors.
FLAGSHP-1 (ERAS-601-01): A Study to Evaluate ERAS-601 in Patients with Advanced or Metastatic Solid Tumors
ClinicalTrials.gov Study Identifier NCT04670679
On any journey involving a fleet, the flagship is the most important ship. ERAS-601 is an investigational therapy that has shown potent anti-cancer activity in animals by blocking SHP2. If ERAS-601 successfully blocks SHP2 and RAS/MAPK activity in patients, it has the potential to become a flagship therapy for patients with various solid tumors. The FLAGSHP-1 trial will test whether ERAS-601 can achieve this.
THUNDERBBOLT-1: A Study to Evaluate ERAS-801 in Patients With Recurrent Glioblastoma
ClinicalTrials.gov Study Identifier NCT05222802
Zeus, the great thunderbolt-wielding god of the sky in ancient Greek mythology, was once felled by an unstoppable growth in his head. Relief came only when Athena, the goddess of wisdom, was released from the confines of his skull. In THUNDERBBOLT-1, we hope to similarly unburden our patients through investigating ERAS-801 in glioblastoma (GBM), a devastating cancer of the brain. ERAS-801 is a highly brain-penetrant targeted inhibitor of EGFR, a protein programmed by the erbb1 gene. Much like the precision of Zeus’ thunderbolt, ERAS-801 is specifically designed to target GBM driven by alterations to erbb1 / EGFR. And, in the spirit of Athena, we hope that this investigation will shed more light on this disease, from predictive biomarkers to possible cures. THUNDERBBOLT-1 is currently underway studying safety and activity in patients with recurrent GBM.
For any questions about our clinical trials, please contact us via email at clinicaltrials@erasca.com