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 | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
ERAS-601 is an investigational small molecule being developed for the treatment of advanced or metastatic solid tumors. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied in patients with advanced or metastatic solid tumors.
ERAS-601 targets SHP2, a protein involved in cell signaling pathways. By inhibiting SHP2, the drug aims to interfere with signaling that can promote tumor growth. This mechanism is being evaluated in the context of advanced or metastatic solid tumors.
ERAS-601 is being developed by Erasca, Inc., a biopharmaceutical company. Erasca is publicly traded on the Nasdaq under the ticker symbol ERAS. The company is conducting clinical trials to evaluate the safety and efficacy of ERAS-601 in patients with advanced or metastatic solid tumors.
ERAS-601 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is designed to evaluate the safety, tolerability, and dosing of ERAS-601 in patients with advanced or metastatic solid tumors.
ERAS-601 is being studied in a Phase 1 clinical trial with the identifier NCT04670679. This trial is titled 'A Dose Escalation/Expansion Study of ERAS-601 in Patients With Advanced or Metastatic Solid Tumors' and is active but not recruiting. The study is enrolling approximately 90 participants in the United States and Australia.
ERAS-601 is a unique investigational compound developed by Erasca, Inc. There are no alternative names provided for this drug. It is being studied under its own name in clinical trials for advanced or metastatic solid tumors.