Metastatic Solid TumorsPhase 1AURORAS-1NCT06983743
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
A Phase 1 study testing ERAS-0015 and ERAS-0015 in combination in people with Metastatic Solid Tumors, run by Erasca, Inc. at 13 sites in 3 countries.
Trial summary
The main purpose of the study is to assess whether the study drug, ERAS-0015, is safe and tolerable when administered to patients with advanced or metastatic solid tumors with certain RAS mutations. ERAS-0015 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-0015 and ERAS-0015 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
- 600 participants
- Where
- 13 sitesin 3 countries
- Study dates
- 5 Jun 2025to 1 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), for applicable cohorts.
- 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. Does not apply to newly diagnosed Pancreatic Ductal Carcinoma (PDAC) cohort.
- 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-0015
- 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
13 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Les Brail, Study Director, PhD contact
13 sites in 3 countries
United States10 sites, 10 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30307
- Recruiting
University of Colorado
Aurora, Colorado, 80045
- Recruiting
Massachusetts General Hospital (MG)
Boston, Massachusetts, 02114
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Recruiting
Providence Medical Group
Santa Rosa, California, 95403
- Recruiting
Florida Cancer Specalists
Sarasota, Florida, 34232
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
- Recruiting
University of Texas at Tyler
Tyler, Texas, 75701
South Korea2 sites, 2 recruiting
- Recruiting
Inje University Haeundae Paik Hospital Clinical Trial Center
Haeundae, Busan, 48108
- Recruiting
Seoul St. Mary's Hospital Clinical Trial Center
Seoul, 06591
Canada1 site, 1 recruiting
- Recruiting
The Princess Margaret Cancer Center
Toronto, Ontario, M5G 2C$
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-0015 Monotherapy and in Combination in Patients Advanced Solid Tumors
The main purpose of the study is to assess whether the study drug, ERAS-0015, is safe and tolerable when administered to patients with advanced or metastatic solid tumors with certain RAS mutations. ERAS-0015 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-0015 as a monotherapy and in combination with other cancer therapies. The study will commence with dose optimization of ERAS-0015 monotherapy, followed by dose optimization of ERAS-0015 in combination with other cancer therapies.
- Conditions
- Metastatic Solid Tumors
- Being tested
- ERAS-0015, ERAS-0015 in combination
- Keywords
- Solid Tumor, Advanced Solid Tumor, solid malignancies, Targeted therapy, Molecular alterations, pembrolizumab, KEYTRUDA ®, panitumumab, Vectibix, Metastatic Solid Tumor, Neoplasms, Colorectal Cancer, Non-small cell lung cancer (NSCLC), Newly diagnosed Pancreatic Ductal Adenocarcinoma, NSCLC patients previously treated with a KRAS G12c inhibitor
- Medical subject headings
- Neoplasm Metastasis, Neoplasms, Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS-0015Drug
ERAS-0015 Administered orally
ERAS-0015 in combinationDrug
Also called pembrolizumab, KEYTRUDA ®, panitumumab, Vectibix
ERAS-0015 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-0015 Monotherapy Dose Optimization. | Experimental | Escalating doses of ERAS-0015 administered orally. Receives: Drug: ERAS-0015 |
| ERAS-0015 Combination Dose Optimization | Experimental | ERAS-0015 administered orally with another investigational agent. Receives: Drug: ERAS-0015 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-0015
Measured: Study Day 1 up to 65
Time to achieve Cmax (Tmax)
Time to achieve maximum plasma concentration of ERAS-0015
Measured: Study Day 1 up to 65
Area under the curve
Area under the plasma concentration-time curve of ERAS-0015
Measured: Study Day 1 up to 65
Half-life
Half-life of ERAS-0015
Measured: Study Day 1 up to 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 posted21 May 2025
- Study start5 Jun 2025
- Primary completion1 May 2028 (estimated)
- Study completion1 Dec 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasca, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Gerri Lee, Study director, Erasca, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983743
- Sponsor's protocol ID
- ERAS-0015-01
- Other IDs
- KEYNOTE-G59, MK-3475-G59, 2026-525794-39-00
- Acronym
- AURORAS-1
- Status last verified
- Nov 2026
- First submitted
- 14 May 2025
- Last updated
- 6 Nov 2026
- 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 6 Nov 2026. 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-0015 Monotherapy and in Combination in Patients Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06983743
- Acronym / sponsor ID
- AURORAS-1 / ERAS-0015-01
- 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
- 600 participants (estimated)
- Lead sponsor
- Erasca, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 21 May 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-0015, is safe and tolerable when administered to patients with advanced or metastatic solid tumors with certain RAS mutations. ERAS-0015 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-0015 as a monotherapy and in combination with other cancer therapies. The study will commence with dose optimization of ERAS-0015 monotherapy, followed by dose optimization of ERAS-0015 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-0015 Monotherapy Dose Optimization. | Experimental | Drug: ERAS-0015Escalating doses of ERAS-0015 administered orally. |
| ERAS-0015 Combination Dose Optimization | Experimental | Drug: ERAS-0015 in combinationERAS-0015 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), for applicable cohorts.
- 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. Does not apply to newly diagnosed Pancreatic Ductal Carcinoma (PDAC) cohort.
- 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-0015
- 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-0015ERAS-0015 Administered orally | Drug | ERAS-0015 Monotherapy Dose Optimization. |
| ERAS-0015 in combinationAlso: pembrolizumab, KEYTRUDA ®, panitumumab, VectibixERAS-0015 Administered orally and in combination with either KEYTRUDA® (pembrolizumab) via IV administration or Vectibix (panitumumab) via IV administration. | Drug | ERAS-0015 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 65
Maximum plasma concentration of ERAS-0015
Time to achieve Cmax (Tmax)
Time frame: Study Day 1 up to 65
Time to achieve maximum plasma concentration of ERAS-0015
Area under the curve
Time frame: Study Day 1 up to 65
Area under the plasma concentration-time curve of ERAS-0015
Half-life
Time frame: Study Day 1 up to 65
Half-life of ERAS-0015
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 6 Nov 2026.
- 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.
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ERAS-0015 and ERAS-0015 in combination in people with Metastatic Solid Tumors, run by Erasca, Inc. at 13 sites in 3 countries.
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 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, South Korea, Canada. 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 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 6 Nov 2026.