Metastatic Solid TumorsPhase 1BOREALIS-1NCT07021898
A Study of ERAS-4001 in Patients With Advanced or Metastatic Solid Tumors.
A Phase 1 study testing ERAS-4001 and ERAS-4001 in combination in people with Metastatic Solid Tumors, run by Erasca, Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Metastatic Solid Tumors
- What is being tested?
- ERAS-4001 and ERAS-4001 in combination
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 5 sitesUnited States
- Study dates
- 6 Aug 2025to Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Les Brail, Study Director, PhD contact
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
NEXT Oncology
Irving, Texas, 75039
- Recruiting
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee, 32703
- Recruiting
NEXT Oncology
San Antonio, Texas, 78229
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
About this study
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
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.
Read the 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.
- Conditions
- Metastatic Solid Tumors
- Being tested
- ERAS-4001, ERAS-4001 in combination
- Keywords
- Solid Tumor, Advanced Solid Tumor, Solid malignancies, Targeted therapy, Molecular alterations, pembrolizumab, Keytruda, panitumumab, Vectibix, Metastatic solid tumor, Neoplasms
- Medical subject headings
- Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS-4001Drug
ERAS-4001 Administered orally
ERAS-4001 in combinationDrug
Also called Keytruda (pembrolizumab), Vectibix (panitumumab)
ERAS-4001 Administered orally and in combination with either Keytruda (pembrolizumab) via IV administration or Vectibix (panitumumab) via IV administration.
| Study group | Role | What they receive |
|---|---|---|
| ERAS-4001 Monotherapy Dose Optimization. | Experimental | Escalating doses of ERAS-4001 administered orally. Receives: Drug: ERAS-4001 |
| ERAS-4001 Combination Dose Optimization | Experimental | ERAS-4001 administered orally with another investigational agent. Receives: Drug: ERAS-4001 in combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities (DLT)
Based on toxicities observed
Measured: Study Day 1 up to Day 21
Maximum tolerated dose (MTD)
Based on toxicities observed
Measured: Study Day 1 up to Day 21
Recommended dose for expansion (RDE)
Based on toxicities observed
Measured: Study Day 1 up to Day 21
Adverse Events
Incidence and severity of treatment-emergent AEs and serious AEs
Measured: Study Day 1 up to Day 21
Plasma concentration (Cmax)
Maximum plasma concentration of ERAS-4001
Measured: Study Day 1 up to Day 65
Time to achieve Cmax (Tmax)
Time of achieve maximum plasma concentration of ERAS-4001
Measured: Study Day 1 up to Day 65
Area under the curve
Area under the plasma concentration-time curve of ERAS-4001
Measured: Study Day 1 up to Day 65
Half-life
Half-life of ERAS-4001
Measured: Study Day 1 up to Day 65
Secondary outcomes (3)
Objective Response Rate (ORR)
Based on assessment of radiographic imaging per RECIST version 1.1
Measured: Assessed up to 24 months from time of first dose
Duration of Response (DOR)
Based on assessment of radiographic imaging per RECIST version 1.1
Measured: Assessed up to 24 months from time of first dose
Time to Response (TTR)
Based on assessment of radiographic imaging per RECIST version 1.1
Measured: Assessed up to 24 months from time of first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start6 Aug 2025
- Primary completionAug 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasca, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerri Lee, Study director, Erasca, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021898
- Sponsor's protocol ID
- ERAS-4001-01
- Acronym
- BOREALIS-1
- Status last verified
- Dec 2025
- First submitted
- 6 Jun 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07021898
- Acronym / sponsor ID
- BOREALIS-1 / ERAS-4001-01
- Conditions
- Metastatic Solid Tumors
- Keywords
- Solid Tumor, Advanced Solid Tumor, Solid malignancies, Targeted therapy, Molecular alterations, pembrolizumab, Keytruda, panitumumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Erasca, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Aug 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS-4001 Monotherapy Dose Optimization. | Experimental | Drug: ERAS-4001Escalating doses of ERAS-4001 administered orally. |
| ERAS-4001 Combination Dose Optimization | Experimental | Drug: ERAS-4001 in combinationERAS-4001 administered orally with another investigational agent. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERAS-4001ERAS-4001 Administered orally | Drug | ERAS-4001 Monotherapy Dose Optimization. |
| ERAS-4001 in combinationAlso: Keytruda (pembrolizumab), Vectibix (panitumumab)ERAS-4001 Administered orally and in combination with either Keytruda (pembrolizumab) via IV administration or Vectibix (panitumumab) via IV administration. | Drug | ERAS-4001 Combination Dose Optimization |
Primary outcome
Dose Limiting Toxicities (DLT)
Time frame: Study Day 1 up to Day 21
Based on toxicities observed
Maximum tolerated dose (MTD)
Time frame: Study Day 1 up to Day 21
Based on toxicities observed
Recommended dose for expansion (RDE)
Time frame: Study Day 1 up to Day 21
Based on toxicities observed
Adverse Events
Time frame: Study Day 1 up to Day 21
Incidence and severity of treatment-emergent AEs and serious AEs
Plasma concentration (Cmax)
Time frame: Study Day 1 up to Day 65
Maximum plasma concentration of ERAS-4001
Time to achieve Cmax (Tmax)
Time frame: Study Day 1 up to Day 65
Time of achieve maximum plasma concentration of ERAS-4001
Area under the curve
Time frame: Study Day 1 up to Day 65
Area under the plasma concentration-time curve of ERAS-4001
Half-life
Time frame: Study Day 1 up to Day 65
Half-life of ERAS-4001
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Les Brail, Study Director, PhD contact
Gerri Lee study director
Erasca, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ERAS-4001 and ERAS-4001 in combination in people with Metastatic Solid Tumors, run by Erasca, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erasca Clinical Team (+1-858-465-6511, clinicaltrials@erasca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicities (DLT) (time frame: Study Day 1 up to Day 21). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.