Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Biliary Tract Cancer

All Drugs and Chemicals

Antibodies

Immunoglobulins

MRG002 will be administrated by an IV infusion of 2.6 mg/kg on Day 1 of every 3 weeks (21-day cycle).

MRG002

Program Director

Mingxi Wang

Aiping Zhou, MD

Mei Guan

Weimin Ding

Yanqiao Zhang

Ying Liu

Jingdong Zhang

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 as single agent in HER2-positive unresectable locally advanced or metastatic biliary tract cancer patients who have progressed during or relapsed after at least one prior stand therapy.

The study consists of two stages. In Phase IIa, 25-31 eligible subjects will be enrolled to evaluate the safety and preliminary efficacy of MRG002. Based on the initial safety and efficacy data obtained from the Phase IIa, the study design of the second stage Phase IIb single-arm study either will be adjusted or the trial will be stopped. If the Phase IIa data support the continuation of the study, in the second stage, approximately an additional 55 subjects will be enrolled to further evaluate the efficacy and safety of MRG002.

A Study of MRG002 in the Treatment of HER2-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer

An Open-label, Single-arm, Multi-center, Phase II Clinical Study of MRG002 in the Treatment of Patients With HER2-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer

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

ORR is defined as the percentage of patients with a CR and PR as assessed by Investigator according to RECIST v1.1.

DOR is defined as the time from first documented objective response to the first onset of tumor progression or death of any cause.

TTR is defined as the duration from the start of treatment to the first onset of CR or PR in tumor evaluation.

DCR is defined as the percentage of patients who achieve CR, PR, and stable disease (SD) after treatment.

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

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.

Concentration-time curve will be depicted based on pharmacokinetics concentration set (PKCS).

The incidence of ADA analysis will be summarized for all patients who received at least one cycle study treatment.

Shanghai Miracogen Inc.

Antineoplastic Agents

Capecitabine

Antimetabolites

* PO varlitinib 300 mg BID
* PO capecitabine 1000 mg/m2 BID

Varlitinib

from Day 1 to Day 14 followed by 7-day of rest period, every 21 days.

The purpose of the study is to assess the efficacy of varlitinib in combination with capecitabine as measured by objective response rate (ORR) assessed by independent central review (ICR), based on RECIST v1.1 criteria.

Also to explore the role of biomarkers as predictors of response and clinical benefit with varlitinib

Are of or older than the legal age in the respective countries at the time when written informed consent is obtained.

Study of Varlitinib Plus Capecitabine in Patients With Advanced or Metastatic Biliary Tract Cancer

A Phase 2, Single Arm Study of Varlitinib Plus Capecitabine in Patients With Advanced or Metastatic Biliary Tract Cancer as First-line Systemic Therapy

Number (%) of patients with at least one visit response of CR or PR. Tumor evaluations will continue until the earlier of disease progression or starting a subsequent anti-cancer therapy.

Use Next generation sequencing/Immunohistochemistry to identify relationships between response to varlitinib and mutations or overexpression in human epidermal growth factor receptor (HER) receptors and the downstream signaling proteins, as well as, mutations in selected cancer pathways.

Defined as the time from start of treatment until the date of objective disease progression or death (by any cause in the absence of disease progression).

Defined as the time from start of treatment until death by any cause.

Defined as the time, in days, from the first recorded achievement of a response (PR or above) until time of objective disease progression in the subset of patients classified as responders in the assessment of ORR

Defined as the proportion of patients with a best response of stable disease maintained for at least 12 weeks (-5 days), PR or CR as defined by RECIST v1.1 criteria.

Defined as the proportion of patients with a best objective response (BOR) of complete response (CR) or partial response (PR), as assessed by the investigator defined by the RECIST v1.1 criteria.

Incidence of Adverse Events, categorized in accordance to CTCAE 4.03 and changes from baseline in safety parameters (including vital signs, ECG parameters, clinical laboratory tests).

ASLAN Pharmaceuticals

Varlitinib given as monotherapy to Japanese subjects with advanced or metastatic solid tumors

Varlitinib given in combination with capecitabine to Japanese subjects with advanced or metastatic biliary tract cancer

varlitinib

capecitabine

The purpose of this study is to explore safety and efficacy of varlitinib administered as monotherapy in Japanese subjects with advanced or metastatic solid tumors, and administered as combination with capecitabine in Japanese subjects with advanced or metastatic biliary tract cancer. Also to evaluate pharmacokinetics (PK) of varlitinib, capecitabine and its metabolite.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of MRG002 in the Treatment of HER2-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer	NCT04837508	Advanced or Met...	MRG002	18 Years - 75 Years	Shanghai Miracogen Inc.
Study of Varlitinib Plus Capecitabine in Patients With Advanced or Metastatic Biliary Tract Cancer	NCT03129074	Advanced or Met...	Varlitinib Capecitabine	18 Years -	ASLAN Pharmaceuticals
A Study of MRG002 in the Treatment of HER2-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer	NCT04837508	Advanced or Met...	MRG002	18 Years - 75 Years	Shanghai Miracogen Inc.
A Study of Varlitinib in Japanese Subjects With Advanced or Metastatic Solid Tumours	NCT03082053	Advanced or Met... Advanced or Met...	varlitinib capecitabine	20 Years -	ASLAN Pharmaceuticals

Spots Global Cancer Trial Database for advanced or metastatic biliary tract cancer