Comparing ERAS-0015 with ERAS-0015 in combination for metastatic solid tumors
Official title: 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
- Phase 1
- 2 groups
- One site, in Toronto
- Recruiting
Interventions
- Medication
ERAS-0015
ERAS-0015 Administered orally
- Medication
ERAS-0015 in combination
ERAS-0015 Administered orally and in combination with either KEYTRUDA® (pembrolizumab) via IV administration or Vectibix (panitumumab) via IV administration.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
The Princess Margaret Cancer Center
Toronto, Ontario
Eligibility Criteria
See who this study is looking for15 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age ≥ 18 years
- +Willing and able to give written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +Pathological documentation of tumor type and mutation prior to the first dose of study drug(s), for applicable cohortsCohortA group of participants sharing a characteristic, followed together.Read more →.
- +There is no available standard systemic therapy available for the patient's tumor histology and/or molecular biomarkerBiomarkerSomething measurable in the body used as a signal of what is happening.Read more → 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 protocolProtocolThe detailed plan a study must follow.Read more →-required visits, assessments, and procedures
Exclusion
- −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
- −Have primary central nervous system (CNS) tumors
- −Have any underlying medical condition, psychiatric condition, or social situation that, in the opinion of the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, would compromise study administration as per protocolProtocolThe detailed plan a study must follow.Read more → or compromise the assessment of AEs
- −Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial
- −Received prior palliative radiation within 14 days of Cycle 1, Day 1
- −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
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more → — an early safety study in a small group, checking how it is tolerated and at what dose.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives ERAS-0015.
Registry label: A: ERAS-0015 Monotherapy Dose Optimization.
Group B receives ERAS-0015 in combination.
Registry label: B: ERAS-0015 Combination Dose Optimization
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 99 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 600 people.
The study is currently expected to finish around December 2028.
The main measurement is taken over: Study Day 1 up to Day 21.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Dose Limiting Toxicities (DLT) — measured over Study Day 1 up to Day 21.
Maximum tolerated doseMaximum tolerated doseThe highest amount that can be given before side effects become unacceptable.Read more → (MTD) — measured over Study Day 1 up to Day 21.
Recommended dose for expansion (RDE) — measured over Study Day 1 up to Day 21.
Adverse EventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → — measured over Study Day 1 up to Day 21.
The study lists 4 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06983743 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About ERAS-0015Drug
ERAS-0015 Administered orally
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About ERAS-0015 in combinationDrug
ERAS-0015 Administered orally and in combination with either KEYTRUDA® (pembrolizumab) via IV administration or Vectibix (panitumumab) via IV administration.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 99 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Groups are assigned by the study team using set rules, rather than by chance.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 99 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Study Day 1 up to Day 21.
The study as a whole is currently expected to finish around 2028-12-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 600 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: Toronto, Ontario, Canada; New York, New York, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, United States
If this study interests you
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Save it to your Collection
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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.