Neoplasms

All Conditions

Symptoms and General Pathology

Carcinoma

Carcinoma, Squamous Cell

Recurrence

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

BYL719 is an oral class I α-specific PI3K inhibitor belonging to the 2-aminothiazole class of compounds.

BYL719

Byung Chul Cho

Byung Chul Cho, M.D., Ph.D.

One promising approach to the treatment of cancer is inhibition or modulating the crucial signal transduction pathway of PI3K-Akt-mTOR. Several PI3K inhibitors are being tested in the clinical trials for cancer treatment but not for the head and neck cancer yet. BYL719 is an alpha specific I PI3K inhibitor. It showed significant, concentration dependent cell growth inhibition and induction of apoptosis. We suggest multicenter single arm phase II study to determine anti-tumor effects of BYL719 in patients with recurrent and/or metastatic SCCHN who failed to prior chemotherapy regimens. Enrollment will be done in 5 or more clinical trial centers in Korea. Primary objective is to evaluate disease control rate (DCR) at 8 weeks of BYL719, and the efficacy will be evaluated by the investigators analysis based on RECIST version 1.1.

An Open Label, Single Arm, Multicenter Phase II Study of BYL719 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck Who Failed to Respond to Platinum-based Therapy.

The primary objective of this study is to evaluate disease control rate (DCR) at 8 weeks of BYL719 administered as therapy for patient with recurrent/metastatic head and neck squamous cell carcinoma, comparing with historical control. Efficacy evaluation will be based on RECIST version 1.1. DCR will be expressed percent and 95% confidence interval.

Yonsei University

Disease Attributes

All Drugs and Chemicals

Antibodies

Immunoglobulins

On the first day of every 3 weeks, MRG003 will be administered via intravenous infusion at 2.0 mg/kg calculated based on the actual body weight

MRG003

Program Director

Ye Guo, Doctor

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 in patients with recurrent or metastatic squamous cell carcinoma of head and neck.

The study consists of two stages. In Part A, approximately 22 patients will be enrolled to evaluate the safety and preliminarily efficacy of MRG003. Based on the initial safety and efficacy data obtained from the Part A, the study design of second stage Part B single-arm study either will be continued or the trail will be terminated. If the Part A data support the continuation of the study, in the second stage, approximately an additional 98 patients will be enrolled to further evaluate the efficacy and safety of MRG003.

A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck

An Open-Label, Single Arm, Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck.

ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed by Independent Review Committee (IRC) according to RECIST v1.1.

ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed by investigator according to RECIST v1.1.

PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.

DOR is defined as the duration from the initial recording of objective disease response to the first onset of tumor progression, or death of any cause.

DCR is defined as the proportions of patients achieving CR, PR, and stable disease (SD) after treatment.

OS is defined as the duration from the start of treatment to death of any cause.

Any reaction, side effect, or untoward event that occurs during the course of the clinical trial whether or not the event is considered related to the study drug.

Area under the curve up to the last validated measurable plasma concentration

The proportion of patients with positive ADA immunogenicity results.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
An Open Label, Single Arm, Multicenter Phase II Study of BYL719 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck Who Failed to Respond to Platinum-based Therapy.	NCT02145312	Recurrent or Me...	BYL719	18 Years -	Yonsei University
A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck	NCT04868162	Recurrent or Me...	MRG003	18 Years -	Shanghai Miracogen Inc.

Spots Global Cancer Trial Database for recurrent or metastatic squamous cell carcinoma of head and neck