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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04866134 | A Study of ERAS-007 as Monotherapy or in Combination With ERAS-601 in Patients With Advanced or Metastatic Solid Tumors | PHASE1 | ACTIVE NOT_RECRUITING | 200 | — | — | May 7, 2021 | Nov 1, 2025 | Aug 27, 2024 | 5 | United States |
Based on adverse events observed
Based on adverse events observed
Based on adverse events observed
Based on adverse events observed
Incidence and severity of treatment-emergent AEs and serious AEs
Maximum plasma concentration of ERAS-007
Time to achieve maximum plasma concentration of ERAS-007 and ERAS-601
Area under the plasma concentration-time curve of ERAS-007 and ERAS-601
Half-life of ERAS-007 and ERAS-601
| Arm | Type | Description |
|---|---|---|
| Dose Escalation (Part A): ERAS-007 Monotherapy, BID-QW dosing | EXPERIMENTAL | ERAS-007 monotherapy will be administered BID-QW in sequential ascending doses to participants with advanced or metastatic solid tumors until unacceptable toxicity, disease progression, or withdrawal of consent. |
| Dose Expansion (Part B): ERAS-007 Monotherapy, QW dosing | EXPERIMENTAL | ERAS-007 monotherapy will be administered at 250 mg QW to participants with advanced or metastatic solid tumors that harbor specific molecular alterations. |
| Dose Expansion (Part C): ERAS-007 Monotherapy, BID-QW dosing (if necessary) | EXPERIMENTAL | Depending on data generated from Part A, ERAS-007 monotherapy may be administered at the BID-QW RD to participants with advanced or metastatic solid tumors that harbor specific molecular alterations. |
| Dose Escalation (Part D): ERAS-007 BID-QW dosing in combination with ERAS-601 | EXPERIMENTAL | Experimental: Dose Escalation (Part D): ERAS-007 BID-QW dosing in combination with ERAS-601 ERAS-007 will be administered BID-QW in combination with ERAS-601 administered BID 3/1 to study participants with advanced or metastatic solid tumors that harbor specific molecular targets in sequential ascending doses until unacceptable toxicity, disease progression, or withdrawal of consent. |
| Name | Type | Description |
|---|---|---|
| ERAS-007 | DRUG | ERAS-007 will be administered orally as specified in Arm description. |
| ERAS-601 | DRUG | ERAS-601 will be administered orally as specified in Arm description. |
Inclusion Criteria: * Age ≥ 18 years. * Willing and able to give written informed consent. * Have histologically or cytologically confirmed advanced or metastatic solid tumor with a relevant molecular alteration (as applicable). * There is no available standard systemic therapy available for the pa...
| 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 |