Actively Recruiting
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
Led by Erasca, Inc. · Updated on 2025-12-03
200
Participants Needed
5
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying ERAS-4001, a drug being evaluated for safety and tolerability in patients with advanced or metastatic solid tumors that have specific KRAS mutations. This first-in-human, Phase 1/1b, open-label, multicenter study aims to find the best doses of ERAS-4001 alone and combined with other cancer therapies. The study is sponsored by Erasca, Inc. and focuses on patients who have limited or no effective standard treatment options available. The study involves two treatment groups: one receiving escalating oral doses of ERAS-4001 alone, and the other receiving ERAS-4001 orally combined with another investigational agent such as Keytruda or Vectibix, administered intravenously. The study begins with dose optimization for ERAS-4001 monotherapy and then moves to dose optimization of ERAS-4001 in combination with other therapies. Treatments are given under close monitoring to determine appropriate dosing and evaluate drug behavior in the body. Participants will be monitored for dose-limiting toxicities, maximum tolerated dose, and adverse events from the first day up to 21 days, with additional pharmacokinetic measurements like plasma concentration and half-life assessed up to 65 days. Researchers will also observe objective response rate, duration, and time to response over a period of up to 24 months. Participants must attend protocol-required visits and assessments to track safety and drug effects during the study and follow-up periods.
CONDITIONS
Brief Title
A Study of ERAS-4001 in Patients With Advanced or Metastatic Solid Tumors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Willing and able to provide written informed consent
- Pathological confirmation of tumor type and mutation before first dose
- No available standard systemic therapy or standard therapy intolerable, ineffective, inaccessible, or refused
- Able to swallow oral medication
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Adequate heart, blood, liver, and kidney function
- Willing to comply with all required visits, assessments, and procedures
You will not qualify if you...
- Previous treatment with a RAS inhibitor
- Currently receiving another study therapy or received investigational therapy within 4 weeks prior to first dose
- Received palliative radiation within 14 days before Cycle 1, Day 1
- Have primary central nervous system tumors
- Prior surgery or gastrointestinal conditions affecting drug absorption
- Any medical, psychiatric, or social condition that may affect study participation or safety assessments
- Pregnant, breastfeeding, or planning to conceive or father children during the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 21 days per dose cycle
Participants receive ERAS-4001 orally as monotherapy or in combination with other cancer therapies. Dose optimization occurs for both monotherapy and combination therapy.
Visits multiple times during each dose cycle up to Day 21
Duration - Up to 24 months
Participants are monitored for safety, pharmacokinetics, and treatment efficacy up to 24 months after the first dose.
Periodic visits for assessments up to 24 months
Trial Site Locations
Total: 5 locations
1
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee, United States, 32703
Actively Recruiting
2
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
3
NEXT Oncology
Irving, Texas, United States, 75039
Actively Recruiting
4
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
5
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
E
Erasca Clinical Team
L
Les Brail, Study Director, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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