NCT02391727

Brief Summary

A first-in-human evaluation of SYN004, a monoclonal antibody that binds to the EGF receptor on cancer cells. Cetuximab, a marketed antibody, has been shown to be effective by inhibiting the growth of cancer cells thereby prolonging the life of patients who have received it. SYN004 is a closely related monoclonal antibody also binds to the EGF receptor in the same way. SYN004 might also inhibit cancer cells and prolong life but has been engineered to avoid some of the hypersensitivity reactions known to provoked by cetuximab.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2015

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

November 16, 2018

Status Verified

November 1, 2018

Enrollment Period

3.4 years

First QC Date

March 9, 2015

Last Update Submit

November 15, 2018

Conditions

Colon Cancer, Breast Cancer, Cancer of the Head and Neck

Keywords

SYN004cetuximab

Outcome Measures

Primary Outcomes (1)

  • Number of patients with adverse events

    cutaneous toxicity, hypersensitivity

    28 days of last SYN004 Administration

Secondary Outcomes (9)

  • maximum plasma concentration (Cmax)

    84 days

  • time to Cmax (Tmax)

    84 days

  • elimination rate constant (λz)

    84 days

  • elimination half-life (t½)

    84 days

  • mean residence time (MRT)

    84 days

  • +4 more secondary outcomes

Other Outcomes (1)

  • To assess biomarkers of relevance to SYN004 mechanism of action and activity

    84 days

Study Arms (1)

SYN004

OTHER

open label study

Biological: SYN004

Interventions

SYN004BIOLOGICAL

subjects who have received effective treatment for their cancers are eligible

SYN004

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Diagnosis of a solid tumor for which the accepted standard of care includesa licensed anti-EGFR therapy;
  • Tumor progression in patients with RAS wild type metastatic colorectal cancer irrespective of their exposure to licensed anti-EGFR therapy including anti-EGFR antibodies; OR Tumor progression in patients with metastatic colorectal cancer refractory to cetuximab or panitumumab or other anti-EGFR antibodies OR Tumor progression in patients with EGFR-mutated non-small cell lung cancer (NSCLC) who have refused therapy.
  • OR Tumor progression or recurrence in patients with squamous cell carcinoma of the head and neck irrespective of their exposure to licensed anti-EGFR therapy including anti-EGFR antibodies.
  • OR Patients with locally advanced or metastatic colorectal carcinoma who have
  • relapsed after standard of care treatment,
  • proved refractory to standard of care treatment
  • refused standard of care treatment
  • been found to be medically unsuitable for standard of care treatment
  • Completion of written informed consent procedure;
  • Male or female subjects over 17 years of age
  • Life expectancy of at least 3 months;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2;
  • At least one measureable non-irradiated site of disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
  • Adequate bone marrow function, with absolute neutrophil count (ANC) \>1,500/mm3, platelet count \>100,000/mm3, and hemoglobin \> 10 g/mm3;
  • Adequate liver function, with bilirubin \<1.5 x the upper limit of the normal range (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<2.5 x the ULN;
  • +26 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Washington University Medical Center

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Colonic NeoplasmsBreast NeoplasmsHead and Neck Neoplasms

Interventions

SYN-004

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • John McClain, MD

    Synermore Biologics Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2015

First Posted

March 18, 2015

Study Start

May 1, 2015

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

November 16, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(2)