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Advanced or Metastatic Solid TumorsPhase 1FLAGSHP-1NCT04670679

A Dose Escalation/Expansion Study of ERAS-601 in Patients With Advanced or Metastatic Solid Tumors

A Phase 1 study testing ERAS-601, Cetuximab and Pembrolizumab in people with Advanced or Metastatic Solid Tumors, run by Erasca, Inc. at 14 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the safety and tolerability of escalating doses of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies in study participants with advanced or metastatic solid tumors. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Advanced or Metastatic Solid Tumors
What is being tested?
ERAS-601, Cetuximab and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
14 sitesin 2 countries
Study dates
15 Dec 2020to 1 Jun 2026
Phase
Phase 1
Are there results?
None posted in the registry

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
  • Have histologically or cytologically confirmed advanced or metastatic solid tumor
  • 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 SHP2 inhibitor
  • Documented PTPN11 mutations
  • 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-601
  • Received prior palliative radiation within 7 days of Cycle 1, Day 1
  • Have primary central nervous system (CNS) disease or known active CNS metastases and/or carcinomatous meningitis
  • 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
Show all 11Show fewer
  • Active, clinically significant interstitial lung disease or pneumonitis
  • History of thromboembolic or cerebrovascular events ≤ 12 weeks prior to the first dose of study treatment
  • History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO
  • 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

14 sites in 2 countries.

14 sites in 2 countries

United States12 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02215

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Mary Crowley Cancer Research

    Dallas, Texas, 75251

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89014

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Sarah Cannon Research Institute (Tennessee Oncology)

    Nashville, Tennessee, 37203

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Sarah Cannon Research Institute (Florida Cancer Specialists)

    Sarasota, Florida, 34232

  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

Australia2 sites

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria

  • Linear Clinical Research

    Perth, Western Australia

Other trials in Australia

About this study

Official title: An Open-Label, Multi-Center Phase 1/1b Dose Escalation and Expansion Study of ERAS-601 SHP2 Inhibitor as a Monotherapy and in Combination With Other Anti-Cancer Therapies in Patients With Advanced or Metastatic Solid Tumors

  • To evaluate the safety and tolerability of escalating doses of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies in study participants with advanced or metastatic solid tumors.
  • To determine the Maximum Tolerated Dose (MTD) and/or recommended dose (RD) of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies.
  • To characterize the pharmacokinetic (PK) profile of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies.
  • To evaluate the antitumor activity of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies.
Read the detailed description

This is a first-in-human, Phase 1/1b, open-label, multicenter clinical study of ERAS-601 as a monotherapy and in combination with other cancer therapies. The study will commence with dose escalation of ERAS-601 monotherapy, followed by dose escalation of ERAS-601 in combination with other cancer therapies. Once the monotherapy MTD and/or RD has been determined, then dose expansion of ERAS-601 monotherapy may commence with enrollment of study participants with advanced or metastatic solid tumors harboring specific molecular alterations. Once the combination therapy MTD and/or RD has been determined, then dose expansion of that combination may commence with enrollment of study participants with advanced or metastatic solid tumors harboring specific molecular alterations.

Being tested
ERAS-601, Cetuximab, Pembrolizumab
Keywords
SHP2, PTPN11, solid tumor, advanced solid tumor, metastatic solid tumor, neoplasms, solid malignancies, targeted therapy, colorectal cancer, CRC, head and neck squamous cell carcinoma, HPV Negative HNSCC, molecular alterations, cetuximab, Erbitux, Chordoma
Medical subject headings
Noonan Syndrome, Neoplasm Metastasis, Neoplasms, Colorectal Neoplasms, Squamous Cell Carcinoma of Head and Neck, Chordoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ERAS-601Drug

    Administered orally

  • CetuximabDrug

    Also called Erbitux

    Administered via intravenous infusion

  • PembrolizumabDrug

    Also called Keytruda

    Administered via intravenous infusion

Study groups in NCT04670679
Study groupRoleWhat they receive
Dose Escalation (Part A): ERAS-601 monotherapyExperimentalERAS-601 monotherapy will be administered in sequential ascending doses to study participants with advanced or metastatic solid tumors until unacceptable toxicity, disease progression, or withdrawal of consent.
Receives: Drug: ERAS-601
Dose Escalation (Part B): ERAS-601 monotherapyExperimentalERAS-601 monotherapy will be administered in sequential ascending doses to study participants with advanced or metastatic solid tumors until unacceptable toxicity, disease progression, or withdrawal of consent.
Receives: Drug: ERAS-601
Dose Escalation (Part C): ERAS-601 monotherapyExperimentalERAS-601 will be administered in sequential ascending doses to study participants with advanced or metastatic solid tumors until unacceptable toxicity, disease progression or withdrawal of consent.
Receives: Drug: ERAS-601
Dose Escalation and Dose Expansion (Part D): ERAS-601 in combination with cetuximabExperimentalERAS-601 will be administered in sequential ascending doses with cetuximab to study participants with advanced metastatic solid tumors until unacceptable toxicity, disease progression or withdrawal of consent. Once the combination therapy recommended dose has been determined, this will be administered to study participants with HPV negative advanced or metastatic head and neck squamous cell carcinoma (HNSCC) or colorectal cancer (CRC).
Receives: Drug: ERAS-601; Drug: Cetuximab
Dose Escalation and Dose Expansion (Part E): ERAS-601 in combination with pembrolizumabExperimentalERAS-601 will be administered in sequential ascending doses with pembrolizumab to study participants with advanced metastatic solid tumors until unacceptable toxicity, disease progression or withdrawal of consent. Once the combination therapy recommended dose has been determined, this will be administered to study participants with HPV negative advanced or metastatic head and neck squamous cell carcinoma (HNSCC) or non small cell lung cancer (NSCLC).
Receives: Drug: ERAS-601; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Limiting Toxicities (DLT)

    Based on toxicities observed

    Measured: Study Day 1 up to Day 29

  2. Maximum tolerated dose (MTD)

    Based on toxicities observed

    Measured: Study Day 1 up to Day 29

  3. Recommended dose (RD)

    Based on toxicities observed

    Measured: Study Day 1 up to Day 29

  4. Adverse Events

    Incidence and severity of treatment-emergent AEs and serious AEs

    Measured: Assessed up to 24 months from time of first dose

  5. Plasma concentration (Cmax)

    Maximum plasma concentration of ERAS-601 and cetuximab or pembrolizumab (if applicable)

    Measured: Study Day 1 up to Day 29

  6. Time to achieve Cmax (Tmax)

    Time to achieve maximum plasma concentration of ERAS-601 and cetuximab or pembrolizumab (if applicable)

    Measured: Study Day 1 up to Day 29

  7. Area under the curve

    Area under the plasma concentration-time curve of ERAS-601 and cetuximab or pembrolizumab (if applicable)

    Measured: Study Day 1 up to Day 29

  8. Half-life

    Half-life of ERAS-601 and cetuximab or pembrolizumab (if applicable)

    Measured: Study Day 1 up to Day 29

Secondary outcomes (3)

  1. 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

  2. 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

  3. 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.

  1. First posted17 Dec 2020
  2. Study start15 Dec 2020
  3. Primary completion1 Feb 2026
  4. Study completion1 Jun 2026

Resources

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
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04670679
Sponsor's protocol ID
ERAS-601-01
Acronym
FLAGSHP-1
Status last verified
Sep 2026
First submitted
11 Dec 2020
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ERAS-601, Cetuximab and Pembrolizumab in people with Advanced or Metastatic Solid Tumors, run by Erasca, Inc. at 14 sites in 2 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 11 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: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States, Australia. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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 29). 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?

On the ClinicalTrials.gov record for NCT04670679.

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 16 Sep 2026.

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