A Study of MRG003 in the Treatment of EGFR-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer

NCT04838964 | Unknown Phase 2

• 1 other identifier: MRG003-003
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 7

Brief Summary

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 as single agent in EGFR-positive unresectable locally advanced or metastatic biliary tract cancer patients who have progressed during or relapsed after at least one prior standard therapy.

Conditions

Advanced or Metastatic Biliary Tract Cancer

Keywords

MRG003; Antibody Drug Conjugate (ADC); EGFR; 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)

MRG003

EXPERIMENTAL

MRG003 will be administrated via IV infusion at 2.0 mg/kg on Day 1 of every 3 weeks (21-day cycle).

Drug: MRG003

Interventions

MRG003 DRUG

Administrated intravenously

MRG003

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.
• EGFR positive 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 MRG003.
• Received chemotherapy, radiotherapy, biologicals, immunotherapy, or other anti-tumor drugs within 4 weeks prior to the first dose.
• 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 the following ophthalmologic abnormalities：severe dry eye syndrome; keratoconjunctivitis sicca; severe exposure keratitis; any other condition that may increase the risk of corneal epithelial damage.
• History of severe skin disease or chronic skin disease requiring oral or intravenous treatment.
• History of interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.
• Peripheral neuropathy greater than Grade 1.
• 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.
• History of cirrhosis (decompensated cirrhosis Child-Pugh class B and C).

Sponsors & Collaborators

• Shanghai Miracogen Inc.: lead

Study Sites (7)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100000, China

RECRUITING

Beijing Youan Hospital,Capital Medical University

Beijing, Beijing Municipality, 100007, China

RECRUITING

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410031, China

RECRUITING

Bethune First Hospital of Jilin University

Changchun, Jilin, 130061, 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 9, 2021
• Study Start: April 28, 2021
• Primary Completion: October 1, 2024
• Study Completion: November 1, 2024
• Last Updated: December 29, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)