A Phase 1/2 interventional study of ERAS-007 and ERAS-601 in Advanced or Metastatic Solid Tumors, sponsored by Erasca, Inc.. Completed at 5 sites in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Erasca, Inc. · Phase 1/2, Interventional, and Treatment
This is a Phase 1b/2, open-label, multicenter clinical study of ERAS-007 monotherapy (QW or BID-QW) administered either QW or BID-QWand ERAS-007 (BID-QW) in combination with ERAS-601 (BID 3/1). The monotherapy RD on a weekly schedule has been determined to be 250 mg QW in a previous study. The dose escalation phases of this study will test ERAS-007 monotherapy administered BID-QW as a monotherapy or in combination with ERAS-601 in participants with any solid tumor. The monotherapy RD on a weekly schedule has been determined to be 250 mg QW in a previous study. In parallel, the dose expansion phase of this study will test ERAS-007 monotherapy administered at the RD of 250 mg QW in participants with advanced or metastatic solid tumors harboring specific molecular alterations. Once sufficient safety and PK data are available from the BID-QW dose escalation phase, the Sponsor will then determine the optimal dose and schedule of ERAS-007 administered as a monotherapy.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's enrollment of 85 is above the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
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Exclusion Criteria:
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.
Drug: ERAS-007
ERAS-007 monotherapy will be administered at 250 mg QW to participants with advanced or metastatic solid tumors that harbor specific molecular alterations.
Drug: ERAS-007
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.
Drug: ERAS-007
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.
Drug: ERAS-007 · Drug: ERAS-601
ERAS-007 will be administered orally as specified in Arm description.
ERAS-601 will be administered orally as specified in Arm description.
Evaluate safety and tolerability of escalating doses of ERAS-007 BID-QW
Based on adverse events observed
Time frame: Assessed up to 24 months from time of first dose
Dose Limiting Toxicities (DLT)
Based on adverse events observed
Time frame: Study Day 1 up to Day 29
Maximum tolerated dose (MTD)
Based on adverse events observed
Time frame: Study Day 1 up to Day 29
Recommended dose (RD)
Based on adverse events observed
Time frame: Study Day 1 up to Day 29
Adverse Events
Incidence and severity of treatment-emergent AEs and serious AEs
Time frame: Assessed up to 24 months from time of first dose
Plasma concentration (Cmax)
Maximum plasma concentration of ERAS-007
Time frame: Study Day 1 up to Day 29
Time to achieve Cmax (Tmax)
Time to achieve maximum plasma concentration of ERAS-007 and ERAS-601
Time frame: Study Day 1 up to Day 29
Area under the curve
Area under the plasma concentration-time curve of ERAS-007 and ERAS-601
Time frame: Study Day 1 up to Day 29
Half-life
Half-life of ERAS-007 and ERAS-601
Time frame: Study Day 1 up to Day 29
Objective Response Rate (ORR)
Based on assessment of radiographic imaging per RECIST version 1.1
Time frame: Assessed up to 24 months from time of first dose
Duration of Response (DOR)
Based on assessment of radiographic imaging per RECIST version 1.1
Time frame: Assessed up to 24 months from time of first dose
Time to Response (TTR)
Based on assessment of radiographic imaging per RECIST version 1.1
Time frame: Assessed up to 24 months from time of first dose
Pharmacodynamic assessment
Assessment of phosphorylated ERK (pERK) inhibition in isolated PBMCs or tumor tissue by immunoblot, IHC or immunofluorescence.
Time frame: Assessed up to 24 months from time of first dose
Plan to share: No
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Erasca, Inc.