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RecruitingInterventionalPhase 1

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

NCT ID: NCT07021898Sponsor: Erasca, Inc.Last updated: 2025-12-03

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.

Detailed description

This is a first-in-human, Phase 1/1b, open-label, multicenter clinical study of ERAS-4001 as a monotherapy and in combination with other cancer therapies. The study will commence with dose optimization of ERAS-4001 monotherapy, followed by dose optimization of ERAS-4001 in combination with other cancer therapies.

Arms & interventions

  • DrugERAS-4001

    ERAS-4001 Administered orally

  • DrugERAS-4001 in combination

    ERAS-4001 Administered orally and in combination with either Keytruda (pembrolizumab) via IV administration or Vectibix (panitumumab) via IV administration.

Outcome measures

Primary

  • Dose Limiting Toxicities (DLT)

    Based on toxicities observed

    Time frame: Study Day 1 up to Day 21

  • Maximum tolerated dose (MTD)

    Based on toxicities observed

    Time frame: Study Day 1 up to Day 21

  • Recommended dose for expansion (RDE)

    Based on toxicities observed

    Time frame: Study Day 1 up to Day 21

  • Adverse Events

    Incidence and severity of treatment-emergent AEs and serious AEs

    Time frame: Study Day 1 up to Day 21

  • Plasma concentration (Cmax)

    Maximum plasma concentration of ERAS-4001

    Time frame: Study Day 1 up to Day 65

  • Time to achieve Cmax (Tmax)

    Time of achieve maximum plasma concentration of ERAS-4001

    Time frame: Study Day 1 up to Day 65

  • Area under the curve

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

    Time frame: Study Day 1 up to Day 65

  • Half-life

    Half-life of ERAS-4001

    Time frame: Study Day 1 up to Day 65

Secondary

  • Objective Response Rate (ORR)

    Time frame: Assessed up to 24 months from time of first dose

  • Duration of Response (DOR)

    Time frame: Assessed up to 24 months from time of first dose

  • Time to Response (TTR)

    Time frame: Assessed up to 24 months from time of first dose

Eligibility criteria

Sex: AllAge: 18 Years to 99 YearsHealthy volunteers: No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Study locations (5)

Sarah Cannon Research Institute (SCRI) Oncology Partners

Nashville, Tennessee, 32703

Recruiting

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting

NEXT Oncology

Irving, Texas, 75039

Recruiting

NEXT Oncology

San Antonio, Texas, 78229

Recruiting

Fred Hutchinson Cancer Center

Seattle, Washington, 98109

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