A Study of ERAS-4001 in Patients With Advanced or Metastatic Solid Tumors.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ERAS-4001, ERAS-4001 in combination.
- Who it may be relevant to
- Registry conditions: Metastatic Solid Tumors. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1 First-in-Human Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ERAS-4001 Monotherapy and in Combination in Patients With Advanced Solid Tumors
Overview
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
- Drug ERAS-4001
ERAS-4001 Administered orally - Drug ERAS-4001 in combination
ERAS-4001 Administered orally and in combination with either Keytruda (pembrolizumab) via IV administration or Vectibix (panitumumab) via IV administration.
Primary outcome measures
- Dose Limiting Toxicities (DLT) [Time frame: Study Day 1 up to Day 21]
- Maximum tolerated dose (MTD) [Time frame: Study Day 1 up to Day 21]
- Recommended dose for expansion (RDE) [Time frame: Study Day 1 up to Day 21]
- Adverse Events [Time frame: Study Day 1 up to Day 21]
- Plasma concentration (Cmax) [Time frame: Study Day 1 up to Day 65]
- Time to achieve Cmax (Tmax) [Time frame: Study Day 1 up to Day 65]
- Area under the curve [Time frame: Study Day 1 up to Day 65]
- Half-life [Time frame: Study Day 1 up to Day 65]
Secondary outcome measures (3)
- Objective Response Rate (ORR) [Time frame: Assessed up to 24 months from time of first dose]
- Duration of Response (DOR) [Time frame: Assessed up to 24 months from time of first dose]
- Time to Response (TTR) [Time frame: Assessed up to 24 months from time of first dose]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 5 centers
- Sarah Cannon Research Institute (SCRI) Oncology Partners — Nashville
- The University of Texas MD Anderson Cancer Center — Houston
- NEXT Oncology — Irving
- NEXT Oncology — San Antonio
- Fred Hutchinson Cancer Center — Seattle
Identifiers
NCT: NCT07021898 · ERAS-4001-01