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

NCT04837508 | Unknown Phase 2

• 1 other identifier: MRG002-002
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Advanced or Metastatic Biliary Tract Cancer

Keywords

MRG002; Antibody Drug Conjugate (ADC); HER2; Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) by Independent Review Committee (IRC)

  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.

  Baseline to study completion, up to 12 months

Secondary Outcomes (9)

• ORR by Investigator

  Baseline to study completion, up to 12 months

• Duration of Response (DoR)

  Baseline to study completion, up to 12 months

• Time to Response (TTR)

  Baseline to study completion, up to 12 months

• Disease Control Rate (DCR)

  Baseline to study completion, up to 12 months

• Progression Free Survival (PFS)

  Baseline to study completion, up to 12 months

Study Arms (1)

MRG002

EXPERIMENTAL

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

Drug: MRG002

Interventions

MRG002 DRUG

Administrated intravenously

MRG002

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to sign the ICF and follow the requirements specified in the protocol.
• Aged 18 to 75 (including 18 and 75), both genders.
• Expected survival time ≥ 12 weeks.
• Patients with unresectable locally advanced or metastatic biliary tract cancer confirmed by histopathology.
• Failed in the prior one or more standard therapies.
• HER2 positive (IHC 3 + or IHC 2 +) in the tumor specimens confirmed by central laboratory test.
• Archival or biopsy tumor specimens should be provided (primary or metastatic).
• Patients must have measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
• ECOG performance score 0 or 1.
• Prior anti-tumor treatment-related AEs (NCI CTCAE v5.0 Criteria) have recovered to ≤ Grade 1 (except alopecia, non-clinically significant or asymptomatic laboratory abnormalities).
• No severe cardiac dysfunction with left ventricular ejection fraction (LVEF) ≥ 50%.
• Organ function must meet the basic requirements.
• Coagulation function must meet the basic requirements.
• Patients of childbearing potential must take effective contraceptive measures during the treatment and for 6 months after the last dose of treatment.

You may not qualify if:

• History of hypersensitivity to any component of MRG002 or history of hypersensitivity of ≥ Grade 3 to trastuzumab.
• Received chemotherapy, radiotherapy, biologicals, immunotherapy, or other anti-tumor drugs within 4 weeks prior to the first MRG002 treatment.
• Presence of clinical manifestation of biliary obstruction.
• Patients with clinical symptoms such as pleural, abdominal or pericardial effusion requiring puncture drainage.
• Presence of central nervous system (CNS) metastasis and/or neoplastic meningitis.
• Any severe or uncontrolled systemic diseases.
• Patients with poorly controlled heart diseases.
• Evidence of active infections, including but not limited to Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) infection.
• History of other primary malignancies.
• History of interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.
• Peripheral neuropathy greater than Grade 1.
• History of cirrhosis (decompensated cirrhosis Child-Pugh class B and C).
• Patients with active autoimmune disease or a history of autoimmune disease, who are using immunosuppressive agents, or systemic hormone therapy and still receiving within 2 weeks prior to enrollment.
• Received anti-tumor vaccine treatment 4 weeks prior to the first dose or planning to participate in anti-tumor vaccine trials.
• Female patents with a positive serum pregnancy test or who are breast-feeding or who do not agree to take adequate contraceptive measures during the treatment and for 6 months after the last dose of study treatment.

Sponsors & Collaborators

• Shanghai Miracogen Inc.: lead

Study Sites (7)

The first affiliated hospital of bengbu medical college

Bengbu, Anhui, 233004, China

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100000, China

RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

ZhuJiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510280, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

Liaoning Cancer Hospital&Institute

Shenyang, Liaoning, 110801, China

RECRUITING

MeSH Terms

Conditions

Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Aiping Zhou, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Program Director

CONTACT

86-21-61637960; clinicaltrials@miracogen.com.cn

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: April 6, 2021
• First Posted: April 8, 2021
• Study Start: June 7, 2021
• Primary Completion: December 1, 2022
• Study Completion: August 1, 2023
• Last Updated: December 10, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)