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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04670679




Registration number
NCT04670679
Ethics application status
Date submitted
11/12/2020
Date registered
17/12/2020

Titles & IDs
Public title
A Dose Escalation/Expansion Study of ERAS-601 in Patients With Advanced or Metastatic Solid Tumors
Scientific title
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 Other Anti-Cancer Therapies in Patients With Advanced or Metastatic Solid Tumors
Secondary ID [1] 0 0
ERAS-601-01
Universal Trial Number (UTN)
Trial acronym
FLAGSHP-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced or Metastatic Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ERAS-601
Treatment: Drugs - Cetuximab
Treatment: Drugs - Pembrolizumab

Experimental: Dose Escalation (Part A): ERAS-601 monotherapy - ERAS-601 monotherapy will be administered in sequential ascending doses to study participants with advanced or metastatic solid tumors until unacceptable toxicity, disease progression, or withdrawal of consent.

Experimental: Dose Escalation (Part B): ERAS-601 monotherapy - ERAS-601 monotherapy will be administered in sequential ascending doses to study participants with advanced or metastatic solid tumors until unacceptable toxicity, disease progression, or withdrawal of consent.

Experimental: Dose Escalation (Part C): ERAS-601 monotherapy - ERAS-601 will be administered in sequential ascending doses to study participants with advanced or metastatic solid tumors until unacceptable toxicity, disease progression or withdrawal of consent.

Experimental: Dose Escalation and Dose Expansion (Part D): ERAS-601 in combination with cetuximab - ERAS-601 will be administered in sequential ascending doses with cetuximab to study participants with advanced metastatic solid tumors until unacceptable toxicity, disease progression or withdrawal of consent. Once the combination therapy recommended dose has been determined, this will be administered to study participants with HPV negative advanced or metastatic head and neck squamous cell carcinoma (HNSCC) or colorectal cancer (CRC).

Experimental: Dose Escalation and Dose Expansion (Part E): ERAS-601 in combination with pembrolizumab - ERAS-601 will be administered in sequential ascending doses with pembrolizumab to study participants with advanced metastatic solid tumors until unacceptable toxicity, disease progression or withdrawal of consent. Once the combination therapy recommended dose has been determined, this will be administered to study participants with HPV negative advanced or metastatic head and neck squamous cell carcinoma (HNSCC) or non small cell lung cancer (NSCLC).


Treatment: Drugs: ERAS-601
Administered orally

Treatment: Drugs: Cetuximab
Administered via intravenous infusion

Treatment: Drugs: Pembrolizumab
Administered via intravenous infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose Limiting Toxicities (DLT)
Timepoint [1] 0 0
Study Day 1 up to Day 29
Primary outcome [2] 0 0
Maximum tolerated dose (MTD)
Timepoint [2] 0 0
Study Day 1 up to Day 29
Primary outcome [3] 0 0
Recommended dose (RD)
Timepoint [3] 0 0
Study Day 1 up to Day 29
Primary outcome [4] 0 0
Adverse Events
Timepoint [4] 0 0
Assessed up to 24 months from time of first dose
Primary outcome [5] 0 0
Plasma concentration (Cmax)
Timepoint [5] 0 0
Study Day 1 up to Day 29
Primary outcome [6] 0 0
Time to achieve Cmax (Tmax)
Timepoint [6] 0 0
Study Day 1 up to Day 29
Primary outcome [7] 0 0
Area under the curve
Timepoint [7] 0 0
Study Day 1 up to Day 29
Primary outcome [8] 0 0
Half-life
Timepoint [8] 0 0
Study Day 1 up to Day 29
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
Assessed up to 24 months from time of first dose
Secondary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
Assessed up to 24 months from time of first dose
Secondary outcome [3] 0 0
Time to Response (TTR)
Timepoint [3] 0 0
Assessed up to 24 months from time of first dose

Eligibility
Key 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
* Able to swallow oral medication
* 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
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous treatment with a SHP2 inhibitor
* Documented PTPN11 mutations
* Is 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-601
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 0 0
Linear Clinical Research - Perth
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment postcode(s) [2] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
Nevada
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Erasca, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Les Brail, PhD
Address 0 0
Clinical Development
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04670679