ERAS-0015 in combination: ERAS-0015 Administered orally and in combination with either KEYTRUDA® (pembrolizumab) via IV administration or Vectibix (panitumumab) via IV administration.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
99 Years
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. 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
Primary outcome measure(s)
Dose Limiting Toxicities (DLT) — Study Day 1 up to Day 21 Based on toxicities observed
Maximum tolerated dose (MTD) — Study Day 1 up to Day 21 Based on toxicities observed
Recommended dose for expansion (RDE) — Study Day 1 up to Day 21 Based on toxicities observed
Adverse Events — Study Day 1 up to Day 21 Incidence and severity of treatment-emergent AEs and serious AEs
Plasma concentration (Cmax) — Study Day 1 up to 65 Maximum plasma concentration of ERAS-0015
Time to achieve Cmax (Tmax) — Study Day 1 up to 65 Time to achieve maximum plasma concentration of ERAS-0015
Area under the curve — Study Day 1 up to 65 Area under the plasma concentration-time curve of ERAS-0015
Half-life — Study Day 1 up to 65 Half-life of ERAS-0015
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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