A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors

NCT06983743 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ERAS-0015-01
• 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-0015, is safe and tolerable when administered to patients with advanced or metastatic solid tumors with certain RAS mutations. ERAS-0015 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-0015

  Study Day 1 up to 65

• Time to achieve Cmax (Tmax)

  Time to achieve maximum plasma concentration of ERAS-0015

  Study Day 1 up to 65

• Area under the curve

  Area under the plasma concentration-time curve of ERAS-0015

  Study Day 1 up to 65

• Half-life

  Half-life of ERAS-0015

  Study Day 1 up to 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-0015 Monotherapy Dose Optimization.

EXPERIMENTAL

Escalating doses of ERAS-0015 administered orally.

Drug: ERAS-0015

ERAS-0015 Combination Dose Optimization

EXPERIMENTAL

ERAS-0015 administered orally with another investigational agent.

Drug: ERAS-0015 in combination

Interventions

ERAS-0015 DRUG

ERAS-0015 Administered orally

ERAS-0015 Monotherapy Dose Optimization.

ERAS-0015 in combination DRUG

ERAS-0015 Administered orally and in combination with either Keytruda (pembrolizumab) via IV administration or Vectibix (panitumumab) via IV administration.

Also known as: Pembrolizumab, Keytruda, Panitumumab, Vectibix

ERAS-0015 Combination 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), for applicable cohorts.
• 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-0015
• 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)

Florida Cancer Specalists

Sarasota, Florida, 34232, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

University of Texas at Tyler

Tyler, Texas, 75701, United States

RECRUITING

NEXT Virginia

Fairfax, Virginia, 22031, 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 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: May 14, 2025
• First Posted: May 21, 2025
• Study Start: June 5, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)