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

  • End date
    May 31, 2024
  • participants needed
  • sponsor
    Erasca, Inc.
Updated on 31 July 2021


  • To evaluate the safety and tolerability of ERAS-601.
    • To determine the ERAS-601 Maximum Tolerated Dose (MTD) and/or recommended dose (RD) as a monotherapy and in combination with a MEK inhibitor.
    • To characterize the pharmacokinetic (PK) profile of ERAS-601 when administered as a monotherapy and in combination with a MEK inhibitor.


This is a first-in-human, Phase 1/1b, open-label, multicenter clinical study of ERAS-601 SHP2 inhibitor as a monotherapy and in combination with a MEK inhibitor. The study will commence with dose escalation of ERAS-601 monotherapy, followed by dose escalation of ERAS-601 in combination with a MEK inhibitor. Once the monotherapy maximum tolerated dose (MTD) and/or recommended dose (RD) has been determined, then dose expansion of ERAS-601 monotherapy may commence. Dose expansion of ERAS-601 in combination with a MEK inhibitor may commence after the combination RD has been determined. Dose expansion will enroll participants with advanced or metastatic solid tumors harboring specific molecular alterations.

Condition Advanced or Metastatic Solid Tumors
Treatment MEK inhibitor, ERAS-601
Clinical Study IdentifierNCT04670679
SponsorErasca, Inc.
Last Modified on31 July 2021


Yes No Not Sure

Inclusion Criteria

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
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

Exclusion Criteria

Is currently receiving another study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of Cycle 1, Day 1
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
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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note