Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ERAS-007 · 3 trials · 4 indications
Based on adverse events observed during dose escalation
Based on adverse events observed during dose escalation
Based on adverse events observed during dose escalation
Incidence and severity of treatment-emergent AEs and serious AEs
Based on adverse events observed
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 (Parts A1a, A2a, or A3a): ERAS-007 in combination with encorafenib and cetuximab | EXPERIMENTAL | ERAS-007 will be orally administered in combination with encorafenib and cetuximab to study participants with BRAFm CRC in sequential ascending doses until unacceptable toxicity, disease progression, or withdrawal of consent. |
| Dose Escalation (Parts B1a, B2a, B3a or B4a): ERAS-007 in combination with palbociclib | EXPERIMENTAL | ERAS-007 will be orally administered in combination with palbociclib to study participants with KRASm or NRASm CRC and KRASm PDAC in sequential ascending doses until unacceptable toxicity, disease progression, or withdrawal of consent. |
| Dose Expan (Parts A1b, A1c, A2b, A2c, A3b, or A3c): ERAS-007 in combo with encorafenib & cetuximab | EXPERIMENTAL | ERAS-007 will be orally administered at the recommended dose (as determined from Parts A1a, A2a or A3a) in combination with encorafenib and cetuximab to study participants with BRAFm CRC. |
| Dose Expansion (Parts B1b, B2b, B3b, and B4b): ERAS-007 in combination with palbociclib | EXPERIMENTAL | ERAS-007 will be orally administered at the recommended dose (as determined from Parts B1a, B2a, B3a or B4a) in combination with palbociclib to study participants with KRASm or NRASm CRC. |
| Dose Escalation (Part 1): ERAS-007 plus osimertinib | EXPERIMENTAL | ERAS-007 will be orally administered in combination with osimertinib to study participants with EGFRm NSCLC in sequential ascending doses until unacceptable toxicity, disease progression, or withdrawal of consent. |
| Dose Escalation (Part 2): ERAS-007 plus sotorasib | EXPERIMENTAL | ERAS-007 will be orally administered in combination with sotorasib to study participants with KRAS G12Cm NSCLC in sequential ascending doses until unacceptable toxicity, disease progression, or withdrawal of consent. |
| Dose Escalation (Part 3): ERAS-601 plus sotorasib | EXPERIMENTAL | ERAS-601 will be orally administered in combination with sotorasib to study participants with KRAS G12Cm NSCLC in sequential ascending doses until unacceptable toxicity, disease progression, or withdrawal of consent. |
| Dose Expansion (Part 4): ERAS-007 plus osimertinib | EXPERIMENTAL | ERAS-007 will be orally administered at the recommended dose (as determined from Part 1) in combination with osimertinib to study participants with EGFRm NSCLC. |
| Dose Expansion (Part 5): ERAS-007 plus sotorasib | EXPERIMENTAL | ERAS-007 will be orally administered at the recommended dose (as determined from Part 2) in combination with sotorasib to study participants with KRAS G12Cm NSCLC. |
| Dose Expansion (Part 6): ERAS-601 plus sotorasib | EXPERIMENTAL | ERAS-601 will be orally administered at the recommended dose (as determined from Part 3) in combination with sotorasib to study participants with KRAS G12Cm NSCLC. |
| 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 | Administered orally |
| Encorafenib | DRUG | Administered orally |
| Cetuximab | DRUG | Administered via intravenous infusion |
| Palbociclib | DRUG | Administered orally |
| ERAS-601 | DRUG | Administered orally |
| Osimertinib | DRUG | Administered orally |
| Sotorasib | DRUG | Administered orally |
Inclusion Criteria: * Age ≥ 18 years. * Willing and able to give written informed consent. * Have histologically or cytologically confirmed metastatic CRC harboring applicable mutation(s) (e.g., BRAF V600E; KRAS or NRAS mutations) or metastatic PDAC harboring KRAS mutation based on an analytically ...
ERAS-007 is an investigational small molecule kinase inhibitor being developed by Erasca, Inc. for advanced solid tumors. It has been studied in Phase 1 clinical trials in patients with advanced non-squamous non-small-cell lung cancer, advanced or metastatic solid tumors, and metastatic colorectal cancer. It is not approved and remains in clinical development.
ERAS-007 targets ERK1/2, which are kinases in the MAPK signaling pathway. By inhibiting ERK1/2, the drug is designed to interfere with signaling that drives tumor cell growth in cancers dependent on that pathway. ERK1/2 inhibition is the mechanism under study across the solid tumor types evaluated.
ERAS-007 is developed by Erasca, Inc., a biopharmaceutical company whose common stock trades on the Nasdaq under the ticker symbol ERAS. Erasca is the sponsor of the Phase 1 studies evaluating ERAS-007 in advanced solid tumors and gastrointestinal malignancies.
ERAS-007 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. The completed Phase 1 studies enrolled patients with advanced non-squamous non-small-cell lung cancer, advanced or metastatic solid tumors, and metastatic colorectal cancer.
ERAS-007 has been evaluated in three completed Phase 1 trials. NCT05039177 studied it in advanced gastrointestinal malignancies, including metastatic colorectal cancer and metastatic pancreatic ductal adenocarcinoma. NCT04959981 studied MAPK pathway therapies in advanced NSCLC, and NCT04866134 studied ERAS-007 as monotherapy or with ERAS-601 in advanced or metastatic solid tumors.
ERAS-007 has been studied both as a monotherapy and in combination with ERAS-601, another Erasca agent, in patients with advanced or metastatic solid tumors in the Phase 1 trial NCT04866134. The other Phase 1 studies evaluated ERAS-007 in advanced gastrointestinal malignancies and in advanced non-squamous NSCLC.