Metastatic Solid Tumors
Conditions
Keywords
Solid Tumor, Advanced Solid Tumor, Solid malignancies, Targeted therapy, Molecular alterations, pembrolizumab, Keytruda, panitumumab, Vectibix, Metastatic solid tumor, Neoplasms
Brief summary
The main purpose of the study is to assess whether the study drug, ERAS-4001, is safe and tolerable when administered to patients with advanced or metastatic solid tumors with certain KRAS mutations. ERAS-4001 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-4001 as a monotherapy and in combination with other cancer therapies. The study will commence with dose optimization of ERAS-4001 monotherapy, followed by dose optimization of ERAS-4001 in combination with other cancer therapies.
Interventions
DRUGERAS-4001
ERAS-4001 Administered orally
DRUGERAS-4001 in combination
ERAS-4001 Administered orally and in combination with either Keytruda (pembrolizumab) via IV administration or Vectibix (panitumumab) via IV administration.
Sponsors
Erasca, Inc.
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) * 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
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-4001 * 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 |
|---|---|---|
| Half-life | Study Day 1 up to Day 65 | Half-life of ERAS-4001 |
| Plasma concentration (Cmax) | Study Day 1 up to Day 65 | Maximum plasma concentration of ERAS-4001 |
| Time to achieve Cmax (Tmax) | Study Day 1 up to Day 65 | Time of achieve maximum plasma concentration of ERAS-4001 |
| Area under the curve | Study Day 1 up to Day 65 | Area under the plasma concentration-time curve of ERAS-4001 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
United States
Contacts
Primary ContactErasca Clinical Team
Backup ContactLes Brail, Study Director, PhD
Outcome results
None listed