A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
ConditionMetastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-99
SponsorErasca, Inc.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
ERAS-0015
DrugERAS-0015 Administered orally
ERAS-0015 in combination
DrugERAS-0015 Administered orally and in combination with either KEYTRUDA® (pembrolizumab) via IV administration or Vectibix (panitumumab) via IV administration.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: ERAS-0015 Monotherapy Dose Optimization.Experimental treatment 1 intervention
Group B: ERAS-0015 Combination Dose OptimizationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose Limiting Toxicities (DLT)
Based on toxicities observed
Time frame
Study Day 1 up to Day 212
Maximum tolerated dose (MTD)
Based on toxicities observed
Time frame
Study Day 1 up to Day 213
Recommended dose for expansion (RDE)
Based on toxicities observed
Time frame
Study Day 1 up to Day 214
Adverse Events
Incidence and severity of treatment-emergent AEs and serious AEs
Time frame
Study Day 1 up to Day 21Secondary outcomes
1
Objective Response Rate (ORR)
Based on assessment of radiographic imaging per RECIST version 1.1
Time frame
Assessed up to 24 months from time of first dose2
Duration of Response (DOR)
Based on assessment of radiographic imaging per RECIST version 1.1
Time frame
Assessed up to 24 months from time of first dose3
Time to Response (TTR)
Based on assessment of radiographic imaging per RECIST version 1.1
Time frame
Assessed up to 24 months from time of first doseSponsors and contacts
Click on the lead sponsor to view all of their trials.
Erasca, Inc.
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov