Actively Recruiting
A Phase 1 First-in-Human Study Evaluating Safety and Tolerability of ERAS-0015 Alone and with Other Therapies in Advanced Solid Tumors
Led by Erasca, Inc. · Updated on 2025-09-11
200
Participants Needed
5
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ERAS-0015, an investigational drug, to determine its safety and tolerability in patients with advanced or metastatic solid tumors that have certain RAS mutations. This Phase 1/1b open-label study aims to understand how ERAS-0015 works alone and when combined with other cancer therapies. It is a first-in-human trial conducted across multiple centers to explore optimal dosing and early effects of the drug. Participants will receive ERAS-0015 orally in escalating doses, either by itself or alongside other investigational agents such as Keytruda or Vectibix, which are given intravenously. The study starts with dose optimization for ERAS-0015 alone, followed by dose optimization when combined with these other cancer treatments. The trial does not include a placebo group and is not randomized. During the study, participants will be monitored closely from Day 1 up to Day 65 for dose-limiting toxicities, drug concentration in plasma, and other pharmacokinetic measures. They will also be assessed for side effects and overall treatment responses for up to 24 months after the first dose. Regular visits will include safety checks, laboratory tests, and evaluations of tumor response, with participant involvement lasting throughout the treatment and follow-up periods.
CONDITIONS
Brief Title
A Study of ERAS-0015 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 give written informed consent
- Pathological documentation of tumor type and mutation before first dose for applicable cohorts
- No available standard systemic therapy for tumor type or standard therapy is intolerable, ineffective, inaccessible, or refused
- Able to swallow oral medication
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Adequate cardiovascular, blood, liver, and kidney function
- Willing to comply with all protocol-required visits, assessments, and procedures
You will not qualify if you...
- Previous treatment with a RAS inhibitor
- Currently receiving other study therapy or participated in investigational study with therapy within 4 weeks before ERAS-0015
- Received palliative radiation within 14 days before Cycle 1, Day 1
- Have primary central nervous system tumors
- Prior surgery or gastrointestinal dysfunction affecting drug absorption
- Any medical, psychiatric, or social condition that may interfere with 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 optimization cycle
Participants receive escalating doses of ERAS-0015 orally either alone or in combination with other cancer therapies to determine safety and tolerability.
Multiple visits during dose optimization cycles
Duration - Up to 24 months
Participants are monitored for response and safety outcomes for up to 24 months from the time of first dose.
Regular follow-up visits over 24 months
Trial Site Locations
Total: 5 locations
1
Florida Cancer Specalists
Sarasota, Florida, United States, 34232
Actively Recruiting
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
3
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
4
University of Texas at Tyler
Tyler, Texas, United States, 75701
Actively Recruiting
5
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
E
Erasca Clinical Team 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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