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A Study of ERAS-007 in Patients With Advanced or Metastatic Solid Tumors (HERKULES-1)

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ClinicalTrials.gov Identifier: NCT04866134
Recruitment Status : Recruiting
First Posted : April 29, 2021
Last Update Posted : July 8, 2021
Sponsor:
Information provided by (Responsible Party):
Erasca, Inc.

Brief Summary:
  • To evaluate the safety and tolerability of ERAS-007 monotherapy administered once weekly (QW) and twice daily-once weekly (BID-QW).
  • To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of ERAS-007 monotherapy administered BID-QW.
  • To characterize the pharmacokinetic (PK) profile of ERAS-007 monotherapy.
  • To determine the optimal dose and schedule of ERAS-007 monotherapy.
  • To evaluate antitumor activity of ERAS-007 in various solid tumors.

Condition or disease Intervention/treatment Phase
Advanced or Metastatic Solid Tumors Drug: ERAS-007 Phase 1 Phase 2

Detailed Description:
This is a Phase 1b/2, open-label, multicenter clinical study of ERAS-007 monotherapy administered either QW or BID-QW. The monotherapy RD on a weekly schedule has been determined to be 250 mg QW in a previous study. The dose escalation phase of this study will test ERAS-007 monotherapy administered BID-QW in participants with any solid tumor. In parallel, the dose expansion phase of this study will test ERAS-007 monotherapy administered at the RD of 250 mg QW in participants with advanced or metastatic solid tumors harboring specific molecular alterations. Once sufficient safety and PK data are available from the BID-QW dose escalation phase, the Sponsor will then determine the optimal dose and schedule of ERAS-007 administered as a monotherapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b/2, Open-label, Multi-center Study of ERAS-007 in Patients With Advanced or Metastatic Solid Tumors (HERKULES-1)
Actual Study Start Date : May 7, 2021
Estimated Primary Completion Date : May 1, 2024
Estimated Study Completion Date : November 1, 2024

Arm Intervention/treatment
Experimental: Dose Escalation (Part A): ERAS-007 Monotherapy, BID-QW dosing
ERAS-007 monotherapy will be administered BID-QW in sequential ascending doses to participants with advanced or metastatic solid tumors until unacceptable toxicity, disease progression, or withdrawal of consent.
Drug: ERAS-007
ERAS-007 will be administered orally as specified in Arm description.

Experimental: Dose Expansion (Part B): ERAS-007 Monotherapy, QW dosing
ERAS-007 monotherapy will be administered at 250 mg QW to participants with advanced or metastatic solid tumors that harbor specific molecular alterations.
Drug: ERAS-007
ERAS-007 will be administered orally as specified in Arm description.

Experimental: Dose Expansion (Part C): ERAS-007 Monotherapy, BID-QW dosing (if necessary)
Depending on data generated from Part A, ERAS-007 monotherapy may be administered at the BID-QW RD to participants with advanced or metastatic solid tumors that harbor specific molecular alterations.
Drug: ERAS-007
ERAS-007 will be administered orally as specified in Arm description.




Primary Outcome Measures :
  1. Evaluate safety and tolerability of escalating doses of ERAS-007 BID-QW [ Time Frame: Assessed up to 24 months from time of first dose ]
    Based on adverse events observed

  2. Dose Limiting Toxicities (DLT) [ Time Frame: Study Day 1 up to Day 29 ]
    Based on adverse events observed

  3. Maximum tolerated dose (MTD) [ Time Frame: Study Day 1 up to Day 29 ]
    Based on adverse events observed

  4. Recommended dose (RD) [ Time Frame: Study Day 1 up to Day 29 ]
    Based on adverse events observed

  5. Adverse Events [ Time Frame: Assessed up to 24 months from time of first dose ]
    Incidence and severity of treatment-emergent AEs and serious AEs

  6. Plasma concentration (Cmax) [ Time Frame: Study Day 1 up to Day 29 ]
    Maximum plasma concentration of ERAS-007

  7. Time to achieve Cmax (Tmax) [ Time Frame: Study Day 1 up to Day 29 ]
    Time to achieve maximum plasma concentration of ERAS-007

  8. Area under the curve [ Time Frame: Study Day 1 up to Day 29 ]
    Area under the plasma concentration-time curve of ERAS-007

  9. Half-life [ Time Frame: Study Day 1 up to Day 29 ]
    Half-life of ERAS-007


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Assessed up to 24 months from time of first dose ]
    Based on assessment of radiographic imaging per RECIST version 1.1

  2. Duration of Response (DOR) [ Time Frame: Assessed up to 24 months from time of first dose ]
    Based on assessment of radiographic imaging per RECIST version 1.1

  3. Time to Response (TTR) [ Time Frame: Assessed up to 24 months from time of first dose ]
    Based on assessment of radiographic imaging per RECIST version 1.1


Other Outcome Measures:
  1. Pharmacodynamic assessment [ Time Frame: Assessed up to 24 months from time of first dose ]
    Assessment of phosphorylated ERK (pERK) inhibition in isolated PBMCs or tumor tissue by immunoblot, IHC or immunofluorescence.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years.
  • Willing and able to give written informed consent.
  • Have histologically or cytologically confirmed advanced or metastatic solid tumor with a relevant molecular alteration (as applicable).
  • 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.
  • Recovered from all toxicities associated with prior treatment to acceptable baseline status.
  • Have ECOG performance status of 0 or 1 with an anticipated life expectancy of > 12 weeks.
  • Willing to comply with all protocol-required visits, assessments, and procedures.
  • Able to swallow tablets.

Exclusion Criteria:

  • 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-007.
  • Received previous treatment with an ERK inhibitor.
  • Received prior antineoplastic therapy within < 21 days or 5 half-lives, whichever is shorter.
  • Received prior palliative radiation within 7 days of first dose of ERAS 007.
  • Received previous treatment with a MAPK inhibitor that resulted in discontinuation due to unacceptable toxicity.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04866134


Contacts
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Contact: Erasca Clinical Team +1-858-465-6511 clinicaltrials@erasca.com

Locations
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United States, Colorado
Sarah Cannon Research Institute (HealthONE) Recruiting
Denver, Colorado, United States, 80218
United States, Florida
Sarah Cannon Research Institute (Florida Cancer Specialists) Recruiting
Sarasota, Florida, United States, 34232
United States, Tennessee
Sarah Cannon Research Institute (Tennessee Oncology) Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Mary Crowley Cancer Research Recruiting
Dallas, Texas, United States, 75251
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Erasca, Inc.
Investigators
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Study Director: Wei Lin, M.D. Chief Medical Officer
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Responsible Party: Erasca, Inc.
ClinicalTrials.gov Identifier: NCT04866134    
Other Study ID Numbers: ERAS-007-01
First Posted: April 29, 2021    Key Record Dates
Last Update Posted: July 8, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Erasca, Inc.:
ERK
solid tumor
advanced solid tumor
metastatic solid tumor
neoplasms
solid malignancies
MAPK
Additional relevant MeSH terms:
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Neoplasms