Metastatic Solid Tumors
Conditions
Keywords
Solid Tumor, Advanced Solid Tumor, solid malignancies, Targeted therapy, Molecular alterations, pembrolizumab, KEYTRUDA ®, panitumumab, Vectibix, Metastatic Solid Tumor, Neoplasms, Colorectal Cancer, Non-small cell lung cancer (NSCLC), Newly diagnosed Pancreatic Ductal Adenocarcinoma, NSCLC patients previously treated with a KRAS G12c inhibitor
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.
Interventions
DRUGERAS-0015
ERAS-0015 Administered orally
DRUGERAS-0015 in combination
ERAS-0015 Administered orally and in combination with either KEYTRUDA® (pembrolizumab) via IV administration or Vectibix (panitumumab) via IV administration.
Sponsors
Erasca, Inc.
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Limiting Toxicities (DLT) | Study Day 1 up to Day 21 | Based on toxicities observed |
| Maximum tolerated dose (MTD) | Study Day 1 up to Day 21 | Based on toxicities observed |
| 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 |
| 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 |
| Half-life | Study Day 1 up to 65 | Half-life of ERAS-0015 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTErasca Clinical Team Team
CONTACTLes Brail, Study Director, PhD
STUDY_DIRECTORGerri Lee
Erasca, Inc.
Outcome results
None listed