A Phase 1 Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
- Conditions
- Metastatic Solid Tumors
- Interventions
- Drug: ERAS-0015 in combination
- Registration Number
- NCT06983743
- Lead Sponsor
- Erasca, Inc.
- Brief 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.
- Detailed Description
This is a first-in-human, Phase 1/1b, open-label, multicenter clinical study of ERAS-0015 as a monotherapy and in combination with other cancer therapies. The study will commence with dose optimization of ERAS-0015 monotherapy, followed by dose optimization of ERAS-0015 in combination with other cancer therapies.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description ERAS-0015 Monotherapy Dose Optimization. ERAS-0015 Escalating doses of ERAS-0015 administered orally. ERAS-0015 Combination Dose Optimization ERAS-0015 in combination ERAS-0015 administered orally with another investigational agent.
- Primary Outcome Measures
Name Time Method Dose Limiting Toxicities (DLT) Study Day 1 up to Day 21 Based on toxicities observed
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
Maximum tolerated dose (MTD) Study Day 1 up to Day 21 Based on toxicities observed
Half-life Study Day 1 up to 65 Half-life of ERAS-0015
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
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) Assessed up to 24 months from time of first dose Based on assessment of radiographic imaging per RECIST version 1.1
Duration of Response (DOR) Assessed up to 24 months from time of first dose Based on assessment of radiographic imaging per RECIST version 1.1
Time to Response (TTR) Assessed up to 24 months from time of first dose Based on assessment of radiographic imaging per RECIST version 1.1