A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Purpose
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.
Condition
- Metastatic Solid Tumors
Eligibility
- Eligible Ages
- Between 18 Years and 99 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
NEXT Virginia
Fairfax, Virginia 22031
Fairfax, Virginia 22031
More Details
- NCT ID
- NCT06983743
- Status
- Recruiting
- Sponsor
- Erasca, Inc.
Detailed Description
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.