NCT03433027

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of intratumoral injections with an Epidermal Growth Factor Receptor (EGFR) AntiSense DNA (BB-401) in patients with metastatic/recurrent HNSCC.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2018

Geographic Reach
2 countries

6 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

February 5, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 14, 2018

Completed
29 days until next milestone

Study Start

First participant enrolled

March 15, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2020

Completed
Last Updated

April 15, 2020

Status Verified

April 1, 2020

Enrollment Period

9 months

First QC Date

February 5, 2018

Last Update Submit

April 13, 2020

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Overall Response (OR) of the injected tumor

    Overall response is defined as Complete Response (CR) or Partial Response (PR) as evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee version 1.1

    Up to 20 months (estimated length of the study)

Secondary Outcomes (4)

  • Disease Control Rate (DCR)

    End of Treatment Visit (Week 9) through to study end (up to 18 months)

  • Progression Free Survival (PFS)

    Up to 20 months (estimated length of study)

  • Overall Survival (OS)

    Up to 20 months (estimated length of study)

  • Duration of Response (DoR)

    20 months (estimated length of study)

Study Arms (1)

BB-401

EXPERIMENTAL

BB-401 Intratumoral injection

Drug: BB-401

Interventions

BB-401DRUG

BB-401 1.92ug/mL Intratumoral Injections, every week for up to 8 weeks

BB-401

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed HNSCC
  • Failed (or are ineligible/decline to receive) all available standard therapies
  • Stable, treated brain metastases
  • One target lesion defined as measurable (via RECIST v1.1), with a maximum longest diameter of 4 cm, and suitable for injection
  • Eastern Cooperative Oncology Group (ECOG) 0-2
  • Agree to biopsies of a selected primary lesion and where possible of a second untreated lesion at baseline and end of treatment
  • Ceased anti-cancer therapy for at least 3 weeks or 5 half-lives for chemotherapy based treatment regimen, or 4 weeks from any therapy with therapeutic biologicals or any type of investigational therapy

You may not qualify if:

  • Nasopharyngeal Carcinoma
  • Concomitant anti-cancer therapy
  • Unresolved toxicities from prior treatments
  • Patients in whom the indicator lesion is at risk of hemorrhage or clinically significant swelling/inflammation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

The Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

Location

Calvary Central Districts Hospital

Elizabeth Vale, South Australia, Australia

Location

Irkutsk Oncology Center

Irkutsk, Russia

Location

Clinical Oncology Dispensary #1

Krasnodar, Russia

Location

Leningrad Regional Oncology Dispensary

Leningrad Region, Russia

Location

Saint Petersburg City Oncology Clinic

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2018

First Posted

February 14, 2018

Study Start

March 15, 2018

Primary Completion

December 12, 2018

Study Completion

April 6, 2020

Last Updated

April 15, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for primary and secondary outcome measures will be made available for the Interim Analysis and routinely through-out the study for the Data Safety Monitoring Board

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
Data will be available within 6-8 weeks from data cut off/lock
Access Criteria
Data will only be available to the Data Safety Monitoring Board and Interim Analysis members

Locations

AU(2)RU(4)