Recruiting
Phase 1

ERAS-0015

Sponsor:

Erasca, Inc.

Code:

NCT06983743

Conditions

Metastatic Solid Tumors

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ERAS-0015

ERAS-0015 in combination

Study Details

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

Study ID

NCT06983743

Start date

Jun 5, 2025

Status verified date

Aug, 2026

Completion date

Dec 1, 2028

Anticipated

Primary completion date

May 1, 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), 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. Does not apply to newly diagnosed Pancreatic Ductal Carcinoma (PDAC) cohort.
  • 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-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

Study Design

Enrollment

600 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ERAS-0015 Monotherapy Dose Optimization.

Escalating doses of ERAS-0015 administered orally.

experimental: ERAS-0015 Combination Dose Optimization

ERAS-0015 administered orally with another investigational agent.

Interventions

ERAS-0015

ERAS-0015 Administered orally

ERAS-0015 in combination

ERAS-0015 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 65 ]
  • Time to achieve Cmax (Tmax) [ Time Frame: Study Day 1 up to 65 ]
  • Area under the curve [ Time Frame: Study Day 1 up to 65 ]
  • Half-life [ Time Frame: Study Day 1 up to 65 ]

Central Contacts and Locations

Central contacts

Erasca Clinical Team Team

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

Locations

Providence Medical Group

Recruiting

Santa Rosa, California, United States, 95403

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Florida Cancer Specalists

Recruiting

Sarasota, Florida, United States, 34232

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Massachusetts General Hospital (MG)

Recruiting

Boston, Massachusetts, United States, 02114

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

University of Texas at Tyler

Recruiting

Tyler, Texas, United States, 75701

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Erasca, Inc.

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • Solid Tumor
  • Advanced Solid Tumor
  • solid malignancies
  • Targeted therapy
  • Molecular alterations
  • pembrolizumab
  • KEYTRUDA ®
  • panitumumab
  • Vectibix
  • Metastatic Solid Tumor
  • Neoplasms
  • Colorectal Cancer
  • Non-small cell lung cancer (NSCLC)
  • Newly diagnosed Pancreatic Ductal Adenocarcinoma
  • NSCLC patients previously treated with a KRAS G12c inhibitor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Erasca, Inc. on 2026-09-01.