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)
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 and SEACRAFT-2, will test whether naporafenib can improve outcomes in patients with pan-RAS Q61X solid tumors, and NRASm melanoma, respectively.
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-3 trial will continue to test the safety and effectiveness of ERAS-007 in trial participants with various gastrointestinal solid tumors
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. The THUNDERBBOLT-1 trial 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
Erasca is a clinical-stage precision oncology company driven by our mission to erase cancer. Evaluation of our investigational therapies in clinical trials is necessary to collect all the information required for regulatory review and to eventually make life-saving therapies commercially available to the relevant patient populations. As such, our development resources are focused on obtaining the efficacy and safety information required for regulatory approval for our investigational therapies as expeditiously and safely as possible. Participation in a clinical trial is the best way for a patient to gain access to investigational therapies. Additional Information about all our ongoing clinical trials can be found at clinicaltrials.gov.
When enrollment into a clinical trial is not possible and all other available treatment options have been exhausted, access to an investigational therapy in the United States may be provided prior to regulatory approval or commercial approval under a provision referred to as “Expanded Access” (sometimes also referred to as “compassionate use”).
Expanded Access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational therapy for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. FDA guidelines indicate that Expanded Access may be appropriate when all of the following apply:
In accordance with the 21st Century Cures Act, Erasca may revise this Expanded Access Policy at any time.
If you have any questions about our Expanded Access Policy, please contact Erasca through the following email address: clinicaltrials@erasca.com.