Description:
- 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.
Title
- Brief Title: A Dose Escalation/Expansion Study of ERAS-601 in Patients With Advanced or Metastatic Solid Tumors
- Official Title: FLAGSHP-1: 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 a MEK Inhibitor in Patients With Advanced or Metastatic Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
ERAS-601-01
- NCT ID:
NCT04670679
Conditions
- Advanced or Metastatic Solid Tumors
Interventions
Drug | Synonyms | Arms |
---|
ERAS-601 | | Dose Escalation (Part A): ERAS-601 Monotherapy, Once daily (QD) dosing |
MEK inhibitor | | Dose Escalation (Part C): ERAS-601 in Combination with a MEK Inhibitor |
Purpose
- 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.
Detailed Description
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Dose Escalation (Part A): ERAS-601 Monotherapy, Once daily (QD) dosing | Experimental | ERAS-601 will be administered QD to participants in sequential ascending doses as a monotherapy until unacceptable toxicity, disease progression, or withdrawal of consent. | |
Dose Escalation (Part B): ERAS-601 Monotherapy, Twice daily (BID) dosing | Experimental | ERAS-601 will be administered BID to participants in sequential ascending doses as a monotherapy until unacceptable toxicity, disease progression, or withdrawal of consent. | |
Dose Escalation (Part C): ERAS-601 in Combination with a MEK Inhibitor | Experimental | ERAS-601 will be administered to participants in sequential ascending doses in combination with a MEK inhibitor until unacceptable toxicity, disease progression, or withdrawal of consent. | |
Dose Expansion (Part D): ERAS-601 Monotherapy | Experimental | ERAS-601 will be administered at the monotherapy recommended dose (as determined from Part A or B) to participants with advanced or metastatic solid tumors that harbor specific molecular alterations. | |
Dose Expansion (Part E): ERAS-601 in Combination with a MEK Inhibitor | Experimental | ERAS-601 will be administered at the combination therapy recommended dose (as determined from Part C) 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
- 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
Maximum Eligible Age: | 99 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Dose Limiting Toxicities (DLT) |
Time Frame: | Study Day 1 up to Day 29 |
Safety Issue: | |
Description: | Based on toxicities 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 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Erasca, Inc. |
Trial Keywords
- SHP2
- PTPN11
- solid tumor
- advanced solid tumor
- metastatic solid tumor
- neoplasms
- solid malignancies
Last Updated
July 23, 2021