A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Advanced NSCLC (HERKULES-2)

  • STATUS
    Recruiting
  • End date
    Mar 25, 2024
  • participants needed
    200
  • sponsor
    Erasca, Inc.
Updated on 25 July 2022

Summary

  • To evaluate the safety and tolerability of escalating doses of ERAS-007 or ERAS-601 in combination with other cancer therapies in study participants with advanced non-small cell lung cancer (NSCLC).
    • To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of ERAS-007 or ERAS-601 administered in combination with other cancer therapies.
    • To evaluate the antitumor activity of ERAS-007 or ERAS-601 in combination with other cancer therapies.
    • To evaluate the PK profiles of ERAS-007 or ERAS-601 and other cancer therapies when administered in combination.

Description

This is a Phase 1b/2, open-label, multicenter master protocol evaluating safety, tolerability, and antitumor activity of ERAS-007 or ERAS-601 in combination with other cancer therapies in study participants with advanced NSCLC. The study will commence with the following dose escalation cohorts: ERAS-007 plus osimertinib in study participants with advanced NSCLC harboring epidermal growth factor receptor-sensitizing mutation(s) (EGFRm); ERAS-007 or ERAS-601 plus sotorasib in study participants with advanced NSCLC harboring Kirsten rat sarcoma G12C mutation (KRAS G12Cm). Dose expansion will follow and will evaluate ERAS-007 or ERAS-601 drug combinations administered at the RD identified from each respective dose escalation cohort in study participants with advanced EGFRm or KRAS G12Cm NSCLC.

Details
Condition Advanced Non-squamous Non-small-cell Lung Cancer
Treatment Osimertinib, Sotorasib, ERAS-601, ERAS-007
Clinical Study IdentifierNCT04959981
SponsorErasca, Inc.
Last Modified on25 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age ≥ 18 years
Willing and able to give written informed consent
Have histologically or cytologically confirmed NSCLC, with presence of EGFR mutation(s) sensitive to EGFR inhibitors, or KRAS G12C mutation
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Adequate bone marrow and organ function
Have ECOG performance status of 0 or 1
Willing to comply with all protocol-required visits, assessments, and procedures
Able to swallow oral medication

Exclusion Criteria

Concurrent treatment with any systemic anticancer therapy for NSCLC, including any approved or investigational agent
For participants with EGFRm NSCLC: prior therapy with a RAS, RAF, MEK, or ERK inhibitor
For participants with KRAS G12Cm NSCLC: prior therapy with a SHP2, ERK, or KRAS G12C inhibitor (depending on which cohort is being considered for enrollment)
Palliative radiotherapy within 7 days of enrollment
History of unacceptable toxicity to treatment with osimertinib or sotorasib
Unresolved toxicities from prior systemic therapy greater than NCI CTCAE grade 1 at time of enrollment, except for toxicities not considered a safety risk (eg, alopecia, vitiligo, and grade 2 neuropathy due to prior chemotherapy)
Major surgery within the 28 days of enrollment
History of another malignancy ≤5 years prior to first dose, except for patients who are disease-free for >2 years after treatment with curative intent or who have carcinoma in situ
Any evidence of severe or uncontrolled systemic disease or evidence of any other significant clinical disorder or laboratory finding that renders the patient inappropriate to participate in the study
Symptomatic and unstable brain metastases, or spinal cord compression, except for patients who have completed definitive therapy (surgery or radiotherapy), are not on steroids, and have a stable neurologic status for a least 2 weeks after completion of the definitive therapy and steroids
Impaired cardiovascular function or clinically significant cardiovascular disease
History of or clinically active ILD, drug induced ILD, or radiation pneumonitis that required steroid treatment
History or current evidence of retinal pigment epithelial detachment (RPED), central serous retinopathy, retinal vein occlusion (RVO), or predisposing factors to RPED or RVO
Pregnant or breastfeeding women
Contraindication to osimertinib or sotorasib use as per local label
Clear my responses

How to participate?

Step 1 Connect with a study center
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

site

0/250

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

Loading...

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 • 

 • 

Private

Reply by • Private
Loading...

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.
Loading...

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