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

NCT ID: NCT06983743

Last Updated: 2025-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-05

Study Completion Date

2028-12-01

Brief Summary

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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.

Detailed Description

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This is a first-in-human, Phase 1/1b, open-label, multicenter clinical study of ERAS-0015 as a monotherapy and in combination with other cancer therapies. The study will commence with dose optimization of ERAS-0015 monotherapy, followed by dose optimization of ERAS-0015 in combination with other cancer therapies.

Conditions

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Metastatic Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ERAS-0015 Monotherapy Dose Optimization.

Escalating doses of ERAS-0015 administered orally.

Group Type EXPERIMENTAL

ERAS-0015

Intervention Type DRUG

ERAS-0015 Administered orally

ERAS-0015 Combination Dose Optimization

ERAS-0015 administered orally with another investigational agent.

Group Type EXPERIMENTAL

ERAS-0015 in combination

Intervention Type DRUG

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

Interventions

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ERAS-0015

ERAS-0015 Administered orally

Intervention Type DRUG

ERAS-0015 in combination

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

Intervention Type DRUG

Other Intervention Names

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Pembrolizumab Keytruda Panitumumab Vectibix

Eligibility Criteria

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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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasca, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gerri Lee

Role: STUDY_DIRECTOR

Erasca, Inc.

Locations

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Florida Cancer Specalists

Sarasota, Florida, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

University of Texas at Tyler

Tyler, Texas, United States

Site Status RECRUITING

NEXT Virginia

Fairfax, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Erasca Clinical Team Team

Role: CONTACT

+1-858-465-6511

Les Brail, Study Director, PhD

Role: CONTACT

Other Identifiers

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ERAS-0015-01

Identifier Type: -

Identifier Source: org_study_id

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