A Study of ERAS-4001 in Patients With Advanced or Metastatic Solid Tumors.
NCT ID: NCT07021898
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
200 participants
INTERVENTIONAL
2025-08-06
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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ERAS-4001 Monotherapy Dose Optimization.
Escalating doses of ERAS-4001 administered orally.
ERAS-4001
ERAS-4001 Administered orally
ERAS-4001 Combination Dose Optimization
ERAS-4001 administered orally with another investigational agent.
ERAS-4001 in combination
ERAS-4001 Administered orally and in combination with either Keytruda (pembrolizumab) via IV administration or Vectibix (panitumumab) via IV administration.
Interventions
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ERAS-4001
ERAS-4001 Administered orally
ERAS-4001 in combination
ERAS-4001 Administered orally and in combination with either Keytruda (pembrolizumab) via IV administration or Vectibix (panitumumab) via IV administration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing and able to give written informed consent
* Pathological documentation of tumor type and mutation prior to the first dose of study drug(s)
* 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
* Able to swallow oral medication
* Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
* Adequate cardiovascular, hematological, liver, and renal function
* Willing to comply with all protocol-required visits, assessments, and procedures
Exclusion Criteria
* Is 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-4001
* Received prior palliative radiation within 14 days of Cycle 1, Day 1
* Have primary central nervous system (CNS) tumors
* 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
18 Years
99 Years
ALL
No
Sponsors
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Erasca, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Gerri Lee
Role: STUDY_DIRECTOR
Erasca, Inc.
Locations
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Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
NEXT Oncology
Irving, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Countries
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Central Contacts
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Les Brail, Study Director, PhD
Role: CONTACT
Other Identifiers
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ERAS-4001-01
Identifier Type: -
Identifier Source: org_study_id
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