A Study of ERAS-007 as Monotherapy or in Combination With ERAS-601 in Patients With Advanced or Metastatic Solid Tumors

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Advanced or Metastatic Solid Tumors

In brief

* To evaluate the safety and tolerability of ERAS-007 monotherapy administered once weekly (QW) and twice daily-once weekly (BID-QW). * To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of ERAS-007 monotherapy administered BID-QW. * To characterize the pharmacokinetic (PK) profile of ERAS-007 monotherapy. * To determine the optimal dose and schedule of ERAS-007 monotherapy. * To evaluate antitumor activity of ERAS-007 in various solid tumors. * To evaluate the safety and tolerability of ERAS-007 (BID-QW) and ERAS-601 (twice daily for three weeks on and 1 week off (BID 3/1)) when administered in combination. * To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of ERAS-007 administered in combination with ERAS-601. * To characterize the pharmacokinetic (PK) profile of ERAS-007 and ERAS-601 when administered in combination. * To evaluate antitumor activity of ERAS-007 and ERAS-601 when administered in combination in various solid tumors * To evaluate antitumor activity of ERAS-007 and ERAS-601 when administered in combination in various solid tumors

Key facts

Study ID

NCT04866134

Run by

Erasca, Inc.

People needed

200

Starts

2021-05-07

Expected to finish

2027-01-01

Last updated by the study team

2026-06-22

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 patient's tumor histology and/or molecular biomarker profile; or standard therapy is intolerable, not effective, or not accessible; or patient has refused standard therapy.
• Recovered from all toxicities associated with prior treatment to acceptable baseline status.
• Have ECOG performance status of 0 or 1 with an anticipated life expectancy of > 12 weeks.
• Willing to comply with all protocol-required visits, assessments, and procedures.
• Able to swallow oral medication.

You may not qualify if…

• Currently receiving another study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of ERAS-007.
• Received previous treatment with an ERK inhibitor.
• For participants being considered for ERAS-007 + ERAS-601 (Part D): prior treatment with SHP2 inhibitor.
• For participants being considered for ERAS-007 + ERAS-601 (Part D): documented PTPN11 mutations
• Received prior antineoplastic therapy within < 21 days or 5 half-lives, whichever is shorter.
• Received prior palliative radiation within 7 days of first dose of ERAS 007 or ERAS-601,
• Received previous treatment with a MAPK inhibitor that resulted in discontinuation due to unacceptable toxicity.
• Prior surgery (e.g., gastric bypass surgery, gastrectomy) or gastrointestinal dysfunction (e.g., Crohn's disease, ulcerative colitis, short gut syndrome) that may affect drug absorption.
• Have any underlying medical condition, psychiatric condition, or social situation that, in the opinion of the Investigator, would compromise study administration as per protocol or compromise the assessment of AEs.
• Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial.

Where it is running

• Sarah Cannon Research Institute (HealthONE) — Denver, Colorado, United States
• Sarah Cannon Research Institute (Florida Cancer Specialists) — Sarasota, Florida, United States
• Sarah Cannon Research Institute (Tennessee Oncology) — Nashville, Tennessee, United States
• Mary Crowley Cancer Research — Dallas, Texas, United States
• NEXT Oncology — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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