Recruiting
Phase 1

ERAS-4001

Sponsor:

Erasca, Inc.

Code:

NCT07021898

Conditions

Metastatic Solid Tumors

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ERAS-4001

ERAS-4001 in combination

Study Details

Brief 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.

Conditions

Metastatic Solid Tumors

Study ID

NCT07021898

Start date

Aug 6, 2025

Status verified date

Dec, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ERAS-4001 Monotherapy Dose Optimization.

Escalating doses of ERAS-4001 administered orally.

experimental: ERAS-4001 Combination Dose Optimization

ERAS-4001 administered orally with another investigational agent.

Interventions

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.

Primary outcome measure

  • Dose Limiting Toxicities (DLT) [ Time Frame: Study Day 1 up to Day 21 ]
  • Maximum tolerated dose (MTD) [ Time Frame: Study Day 1 up to Day 21 ]
  • Recommended dose for expansion (RDE) [ Time Frame: Study Day 1 up to Day 21 ]
  • Adverse Events [ Time Frame: Study Day 1 up to Day 21 ]
  • Plasma concentration (Cmax) [ Time Frame: Study Day 1 up to Day 65 ]
  • Time to achieve Cmax (Tmax) [ Time Frame: Study Day 1 up to Day 65 ]
  • Area under the curve [ Time Frame: Study Day 1 up to Day 65 ]
  • Half-life [ Time Frame: Study Day 1 up to Day 65 ]

Central Contacts and Locations

Central contacts

Erasca Clinical Team

+1-858-465-6511clinicaltrials@erasca.com

Locations

Sarah Cannon Research Institute (SCRI) Oncology Partners

Recruiting

Nashville, Tennessee, United States, 32703

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

NEXT Oncology

Recruiting

Irving, Texas, United States, 75039

NEXT Oncology

Recruiting

San Antonio, Texas, United States, 78229

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

More Information

Sponsor

Erasca, Inc.

Last update posted

Dec 3, 2025

Last verified

Dec, 2025

Keywords

  • Solid Tumor
  • Advanced Solid Tumor
  • Solid malignancies
  • Targeted therapy
  • Molecular alterations
  • pembrolizumab
  • Keytruda
  • panitumumab
  • Vectibix
  • Metastatic solid tumor
  • Neoplasms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Erasca, Inc. on 2025-12-03.