A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
The registry record from ClinicalTrials.gov (public domain): summary, interventions, outcomes and eligibility. Questions are answered only with quotes from this document. Source: ClinicalTrials.gov, retrieved 2026-11-05.
Ongoing
Record metadata
- Phase
- Phase 1
- Status
- Recruiting
- Start
- 2025-06-05
- End
- 2028-12-01
- Enrollment
- 600
- Sites
- 9
- Sponsor class
- INDUSTRY
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Source text
Brief summary · public domain (ClinicalTrials.gov) · T1
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 · public domain (ClinicalTrials.gov) · T1
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.
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: ERAS-0015. ERAS-0015 Administered orally
Intervention · public domain (ClinicalTrials.gov) · T1
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.
Arm · public domain (ClinicalTrials.gov) · T1
ERAS-0015 Monotherapy Dose Optimization. (experimental): Escalating doses of ERAS-0015 administered orally.
Arm · public domain (ClinicalTrials.gov) · T1
ERAS-0015 Combination Dose Optimization (experimental): ERAS-0015 administered orally with another investigational agent.
Primary outcome · public domain (ClinicalTrials.gov) · T1
Dose Limiting Toxicities (DLT). Based on toxicities observed Time frame: Study Day 1 up to Day 21.
Primary outcome · public domain (ClinicalTrials.gov) · T1
Maximum tolerated dose (MTD). Based on toxicities observed Time frame: Study Day 1 up to Day 21.
Primary outcome · public domain (ClinicalTrials.gov) · T1
Recommended dose for expansion (RDE). Based on toxicities observed Time frame: Study Day 1 up to Day 21.
Primary outcome · public domain (ClinicalTrials.gov) · T1
Adverse Events. Incidence and severity of treatment-emergent AEs and serious AEs Time frame: Study Day 1 up to Day 21.
Primary outcome · public domain (ClinicalTrials.gov) · T1
Plasma concentration (Cmax). Maximum plasma concentration of ERAS-0015 Time frame: Study Day 1 up to 65.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Objective Response Rate (ORR). Time frame: Assessed up to 24 months from time of first dose.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Duration of Response (DOR). Time frame: Assessed up to 24 months from time of first dose.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Time to Response (TTR). Time frame: Assessed up to 24 months from time of first dose.
Eligibility · public domain (ClinicalTrials.gov) · T1
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
Enrollment · public domain (ClinicalTrials.gov) · T1
Enrollment: 600 participants (estimated).