Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ERAS-601 · 1 trial · 1 indication
Based on toxicities observed
Based on toxicities observed
Based on toxicities observed
Incidence and severity of treatment-emergent AEs and serious AEs
Maximum plasma concentration of ERAS-601 and cetuximab or pembrolizumab (if applicable)
Time to achieve maximum plasma concentration of ERAS-601 and cetuximab or pembrolizumab (if applicable)
Area under the plasma concentration-time curve of ERAS-601 and cetuximab or pembrolizumab (if applicable)
Half-life of ERAS-601 and cetuximab or pembrolizumab (if applicable)
| Arm | Type | Description |
|---|---|---|
| Dose Escalation (Part A): ERAS-601 monotherapy | EXPERIMENTAL | ERAS-601 monotherapy will be administered in sequential ascending doses to study participants with advanced or metastatic solid tumors until unacceptable toxicity, disease progression, or withdrawal of consent. |
| Dose Escalation (Part B): ERAS-601 monotherapy | EXPERIMENTAL | ERAS-601 monotherapy will be administered in sequential ascending doses to study participants with advanced or metastatic solid tumors until unacceptable toxicity, disease progression, or withdrawal of consent. |
| Dose Escalation (Part C): ERAS-601 monotherapy | EXPERIMENTAL | ERAS-601 will be administered in sequential ascending doses to study participants with advanced or metastatic solid tumors until unacceptable toxicity, disease progression or withdrawal of consent. |
| Dose Escalation and Dose Expansion (Part D): ERAS-601 in combination with cetuximab | EXPERIMENTAL | ERAS-601 will be administered in sequential ascending doses with cetuximab to study participants with advanced metastatic solid tumors until unacceptable toxicity, disease progression or withdrawal of consent. Once the combination therapy recommended dose has been determined, this will be administered to study participants with HPV negative advanced or metastatic head and neck squamous cell carcinoma (HNSCC) or colorectal cancer (CRC). |
| Dose Escalation and Dose Expansion (Part E): ERAS-601 in combination with pembrolizumab | EXPERIMENTAL | ERAS-601 will be administered in sequential ascending doses with pembrolizumab to study participants with advanced metastatic solid tumors until unacceptable toxicity, disease progression or withdrawal of consent. Once the combination therapy recommended dose has been determined, this will be administered to study participants with HPV negative advanced or metastatic head and neck squamous cell carcinoma (HNSCC) or non small cell lung cancer (NSCLC). |
| Name | Type | Description |
|---|---|---|
| ERAS-601 | DRUG | Administered orally |
| Cetuximab | DRUG | Administered via intravenous infusion |
| Pembrolizumab | DRUG | Administered via intravenous infusion |
Inclusion Criteria: * Age ≥ 18 years * Willing and able to give written informed consent * Have histologically or cytologically confirmed advanced or metastatic solid tumor * There is no available standard systemic therapy available for the patient's tumor histology and/or molecular biomarker profi...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
ERAS-601 is an investigational small molecule being studied for the treatment of advanced or metastatic solid tumors. It is being developed by Erasca, Inc. as an oral therapy for patients with these tumor types, and it has been evaluated in a Phase 1 dose escalation and expansion study.
ERAS-601 targets SHP2, a protein involved in cell signaling. By inhibiting SHP2, the drug is designed to interfere with signaling pathways that drive tumor growth. SHP2 inhibition is being explored as a strategy in oncology for cancers dependent on these pathways.
ERAS-601 is being developed by Erasca, Inc., a biopharmaceutical company that trades under the ticker symbol ERAS. Erasca focuses on discovering and developing therapies for cancer, and ERAS-601 is one of its clinical-stage programs.
ERAS-601 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The Phase 1 study evaluating the drug has been completed, and the program remains in early-stage clinical testing for advanced or metastatic solid tumors.
ERAS-601 has been evaluated in the Phase 1 trial NCT04670679, titled a dose escalation and expansion study in patients with advanced or metastatic solid tumors. The trial enrolled 90 patients across the United States and Australia and is listed as completed.