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 Sex
- 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
Florida Cancer Specalists
Sarasota 4172131, Florida 4155751 34232
Sarasota 4172131, Florida 4155751 34232
Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10065
New York 5128581, New York 5128638 10065
The University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
University of Texas at Tyler
Tyler 4738214, Texas 4736286 75701
Tyler 4738214, Texas 4736286 75701
NEXT Virginia
Fairfax 4758023, Virginia 6254928 22031
Fairfax 4758023, Virginia 6254928 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.