A Study of ERAS-4001 in Patients With Advanced or Metastatic Solid Tumors.

NCT07021898
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
200
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Lead sponsor
Erasca, Inc.
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Start date
2025-08-06
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Number of sites
5
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Summary
The main purpose of the study is to assess whether the study drug, ERAS-4001, is safe and tolerable when administered to patients with advanced or metastatic solid tumors with certain KRAS mutations. ERAS-4001 will be given alone or in combination with other treatments.
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Acronym
BOREALIS-1
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Short title
A Study of ERAS-4001 in Patients With Advanced or Metastatic Solid Tumors.
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Official title
A Phase 1 First-in-Human Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ERAS-4001 Monotherapy and in Combination in Patients With Advanced Solid Tumors
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2028-12-01
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First posted
2025-06-15
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Registry last updated
2025-12-03
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Primary completion date
2028-08-01
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Start date
2025-08-06
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Participants
200
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Participant count basis
Estimated
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Planned participants
200
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Protocol amendments
1
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Number of sites
5
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Erasca, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07021898
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ClinicalTrials.gov ID
NCT07021898
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Dose Limiting Toxicities (DLT)

    Timeframe: Study Day 1 up to Day 21

    Based on toxicities observed

  2. Maximum tolerated dose (MTD)

    Timeframe: Study Day 1 up to Day 21

    Based on toxicities observed

  3. Recommended dose for expansion (RDE)

    Timeframe: Study Day 1 up to Day 21

    Based on toxicities observed

  4. Adverse Events

    Timeframe: Study Day 1 up to Day 21

    Incidence and severity of treatment-emergent AEs and serious AEs

  5. Plasma concentration (Cmax)

    Timeframe: Study Day 1 up to Day 65

    Maximum plasma concentration of ERAS-4001

  6. Time to achieve Cmax (Tmax)

    Timeframe: Study Day 1 up to Day 65

    Time of achieve maximum plasma concentration of ERAS-4001

  7. Area under the curve

    Timeframe: Study Day 1 up to Day 65

    Area under the plasma concentration-time curve of ERAS-4001

  8. Half-life

    Timeframe: Study Day 1 up to Day 65

    Half-life of ERAS-4001

  1. Objective Response Rate (ORR)

    Timeframe: Assessed up to 24 months from time of first dose

    Based on assessment of radiographic imaging per RECIST version 1.1

  2. Duration of Response (DOR)

    Timeframe: Assessed up to 24 months from time of first dose

    Based on assessment of radiographic imaging per RECIST version 1.1

  3. Time to Response (TTR)

    Timeframe: Assessed up to 24 months from time of first dose

    Based on assessment of radiographic imaging per RECIST version 1.1

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
99 Years
Healthy volunteers
No

  • Age ≥ 18 years
  • 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

  • Previous treatment with a RAS inhibitor
  • 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
Sources for eligibility
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  • Sarah Cannon Research Institute (SCRI) Oncology PartnersNashville, United StatesRecruiting
  • The University of Texas MD Anderson Cancer CenterHouston, United StatesRecruiting
  • NEXT OncologyIrving, United StatesRecruiting
  • NEXT OncologySan Antonio, United StatesRecruiting
  • Fred Hutchinson Cancer CenterSeattle, United StatesRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)