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

NCT07021898 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ERAS-4001-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 5

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

Keywords

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

Outcome Measures

Primary Outcomes (8)

• Dose Limiting Toxicities (DLT)

  Based on toxicities observed

  Study Day 1 up to Day 21

• Maximum tolerated dose (MTD)

  Based on toxicities observed

  Study Day 1 up to Day 21

• Recommended dose for expansion (RDE)

  Based on toxicities observed

  Study Day 1 up to Day 21

• Adverse Events

  Incidence and severity of treatment-emergent AEs and serious AEs

  Study Day 1 up to Day 21

• Plasma concentration (Cmax)

  Maximum plasma concentration of ERAS-4001

  Study Day 1 up to Day 65

• Time to achieve Cmax (Tmax)

  Time of achieve maximum plasma concentration of ERAS-4001

  Study Day 1 up to Day 65

• Area under the curve

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

  Study Day 1 up to Day 65

• Half-life

  Half-life of ERAS-4001

  Study Day 1 up to Day 65

Secondary Outcomes (3)

• Objective Response Rate (ORR)

  Assessed up to 24 months from time of first dose

• Duration of Response (DOR)

  Assessed up to 24 months from time of first dose

• Time to Response (TTR)

  Assessed up to 24 months from time of first dose

Study Arms (2)

ERAS-4001 Monotherapy Dose Optimization.

EXPERIMENTAL

Escalating doses of ERAS-4001 administered orally.

Drug: ERAS-4001

ERAS-4001 Combination Dose Optimization

EXPERIMENTAL

ERAS-4001 administered orally with another investigational agent.

Drug: ERAS-4001 in combination

Interventions

ERAS-4001 in combination DRUG

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

Also known as: Keytruda (pembrolizumab), Vectibix (panitumumab)

ERAS-4001 Combination Dose Optimization

ERAS-4001 DRUG

ERAS-4001 Administered orally

ERAS-4001 Monotherapy Dose Optimization.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasca, Inc.: lead

Study Sites (5)

Sarah Cannon Research Institute (SCRI) Oncology Partners

Nashville, Tennessee, 32703, United States

RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

NEXT Oncology

Irving, Texas, 75039, United States

RECRUITING

NEXT Oncology

San Antonio, Texas, 78229, United States

RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis; Neoplasms

Interventions

pembrolizumab; Panitumumab

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Gerri Lee

  Erasca, Inc.

  STUDY DIRECTOR

Central Study Contacts

Erasca Clinical Team

CONTACT

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

Les Brail, Study Director, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 15, 2025
• Study Start: August 6, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)