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

NCT06983743
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
600
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Lead sponsor
Erasca, Inc.
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Start date
2025-06-05
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Number of sites
8
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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.
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Acronym
AURORAS-1
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Short title
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
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Official title
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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2028-12-01
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First posted
2025-05-21
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Registry last updated
2026-07-31
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Primary completion date
2028-05-01
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Start date
2025-06-05
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Participants
600
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Participant count basis
Estimated
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Planned participants
600
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Protocol amendments
2
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Number of sites
8
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Erasca, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06983743
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ClinicalTrials.gov ID
NCT06983743
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Dose Limiting Toxicities (DLT)

    Timeframe: Study Day 1 up to Day 21

    Based on toxicities observed

  2. Maximum tolerated dose (MTD)

    Timeframe: Study Day 1 up to Day 21

    Based on toxicities observed

  3. Recommended dose for expansion (RDE)

    Timeframe: Study Day 1 up to Day 21

    Based on toxicities observed

  4. Adverse Events

    Timeframe: Study Day 1 up to Day 21

    Incidence and severity of treatment-emergent AEs and serious AEs

  5. Plasma concentration (Cmax)

    Timeframe: Study Day 1 up to 65

    Maximum plasma concentration of ERAS-0015

  6. Time to achieve Cmax (Tmax)

    Timeframe: Study Day 1 up to 65

    Time to achieve maximum plasma concentration of ERAS-0015

  7. Area under the curve

    Timeframe: Study Day 1 up to 65

    Area under the plasma concentration-time curve of ERAS-0015

  8. Half-life

    Timeframe: Study Day 1 up to 65

    Half-life of ERAS-0015

  1. Objective Response Rate (ORR)

    Timeframe: Assessed up to 24 months from time of first dose

    Based on assessment of radiographic imaging per RECIST version 1.1

  2. Duration of Response (DOR)

    Timeframe: Assessed up to 24 months from time of first dose

    Based on assessment of radiographic imaging per RECIST version 1.1

  3. Time to Response (TTR)

    Timeframe: Assessed up to 24 months from time of first dose

    Based on assessment of radiographic imaging per RECIST version 1.1

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
99 Years
Healthy volunteers
No

  • 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

  • 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
Sources for eligibility
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  • Providence Medical GroupSanta Rosa, United StatesRecruiting
  • Florida Cancer SpecalistsSarasota, United StatesRecruiting
  • Moffitt Cancer CenterTampa, United StatesRecruiting
  • Massachusetts General Hospital (MG)Boston, United StatesRecruiting
  • Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting
  • The University of Texas MD Anderson Cancer CenterHouston, United StatesRecruiting
  • University of Texas at TylerTyler, United StatesRecruiting
  • NEXT VirginiaFairfax, United StatesRecruiting
Sources for sites
clinicaltrials.gov

  • 2026-525794-39-00
  • KEYNOTE-G59
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Collaborators (1)

Lead sponsors (1)

Conditions (2)