Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04670679 | A Dose Escalation/Expansion Study of ERAS-601 in Patients With Advanced or Metastatic Solid Tumors | PHASE1 | ACTIVE NOT_RECRUITING | 90 | — | — | Dec 15, 2020 | Jun 1, 2026 | Mar 25, 2026 | 14 | United States, Australia |
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, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |