Description:
- 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.
Title
- Brief Title: A Study of ERAS-007 in Patients With Advanced or Metastatic Solid Tumors
- Official Title: A Phase 1b/2, Open-label, Multi-center Study of ERAS-007 in Patients With Advanced or Metastatic Solid Tumors (HERKULES-1)
Clinical Trial IDs
- ORG STUDY ID:
ERAS-007-01
- NCT ID:
NCT04866134
Conditions
- Advanced or Metastatic Solid Tumors
Interventions
Drug | Synonyms | Arms |
---|
ERAS-007 | | Dose Escalation (Part A): ERAS-007 Monotherapy, BID-QW dosing |
Purpose
- 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.
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Dose Escalation (Part A): ERAS-007 Monotherapy, BID-QW dosing | Experimental | 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. | |
Dose Expansion (Part B): ERAS-007 Monotherapy, QW dosing | Experimental | ERAS-007 monotherapy will be administered at 250 mg QW to participants with advanced or metastatic solid tumors that harbor specific molecular alterations. | |
Dose Expansion (Part C): ERAS-007 Monotherapy, BID-QW dosing (if necessary) | Experimental | 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. | |
Eligibility 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.
Maximum Eligible Age: | 99 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Evaluate safety and tolerability of escalating doses of ERAS-007 BID-QW |
Time Frame: | Assessed up to 24 months from time of first dose |
Safety Issue: | |
Description: | Based on adverse events observed |
Secondary Outcome Measures
Measure: | Objective Response Rate (ORR) |
Time Frame: | Assessed up to 24 months from time of first dose |
Safety Issue: | |
Description: | Based on assessment of radiographic imaging per RECIST version 1.1 |
Measure: | Duration of Response (DOR) |
Time Frame: | Assessed up to 24 months from time of first dose |
Safety Issue: | |
Description: | Based on assessment of radiographic imaging per RECIST version 1.1 |
Measure: | Time to Response (TTR) |
Time Frame: | Assessed up to 24 months from time of first dose |
Safety Issue: | |
Description: | Based on assessment of radiographic imaging per RECIST version 1.1 |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Erasca, Inc. |
Trial Keywords
- ERK
- solid tumor
- advanced solid tumor
- metastatic solid tumor
- neoplasms
- solid malignancies
- MAPK
Last Updated
July 8, 2021