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RecruitingPhase 1

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

A Phase 1 First-in-Human Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ERAS-0015 Monotherapy and in Combination in Patients Advanced Solid Tumors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 99 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of ERAS-0015 and how well people can tolerate it, alone or with other treatments. It is for adults with solid tumors that are advanced or have spread and have certain changes in genes called RAS.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old.
  • Be willing and able to sign a form agreeing to join the study.
  • For some study groups, have lab records showing the tumor type and gene change before the first dose.
  • Have no standard whole-body treatment available, or it cannot be tolerated, does not work, cannot be accessed, or was refused. This rule does not apply to the group with newly diagnosed pancreatic ductal cancer (PDAC).
  • Be able to swallow medicine.
  • Be fully active or able to do light work, even if heavy activity is limited (ECOG score of 0 or 1).
  • Have heart, blood, liver, and kidney function that meets study requirements.
  • Be willing to attend all required visits and complete study tests and procedures.

Who can't join

  • Have been treated with a RAS inhibitor, a drug that blocks RAS.
  • Are receiving another study treatment, or received an experimental study treatment within 4 weeks before the first ERAS-0015 dose.
  • Had radiation to ease symptoms within 14 days before the first treatment day.
  • Have a tumor that started in the brain or spinal cord.
  • Have had stomach or bowel surgery, or have digestive problems, that may affect how your body takes in the drug.
  • Have a medical or mental health condition, or a social situation, that the study doctor thinks could interfere with study care or checking side effects.
  • Are pregnant or breastfeeding, or expect to become pregnant or father a child during the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (9)

CA

CO

FL

MA

NY

TX

VA