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

Advanced or Metastatic Biliary Tract Cancer Clinical Trial

Official title:

An Open-label, Single-arm, Multi-center, Phase II Clinical Study of MRG003 in the Treatment of Patients With EGFR-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04838964
• Other study ID #: MRG003-003
• Status: Recruiting
• Phase: Phase 2
• Start date: April 28, 2021
• Est. completion date: November 2024

Study information

• Verified date: December 2021
• Source: Shanghai Miracogen Inc.
• Contact: Program Director
• Phone: 86-21-61637960
• Email: clinicaltrials[@]miracogen.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study consists of two stages. In Phase IIa, approximately 25 subjects will be enrolled to evaluate the safety and preliminarily efficacy of MRG003. Based on the 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 initial 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 MRG003.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Willing to sign the ICF and follow the requirements specified in the protocol.

2. Aged 18 to 75 (including 18 and 75), both genders.

3. Expected survival time = 12 weeks.

4. Patients with unresectable locally advanced or metastatic biliary tract cancer confirmed by histopathology.

5. Failed in the prior one or more standard therapies.

6. EGFR positive in the tumor specimens confirmed by central laboratory test.

7. Archival or biopsy tumor specimens should be provided (primary or metastatic).

8. Patients must have measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

9. ECOG performance score 0 or 1.

10. 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).

11. No severe cardiac dysfunction with left ventricular ejection fraction (LVEF) = 50%.

12. Organ function must meet the basic requirements.

13. Coagulation function must meet the basic requirements.

14. Patients of childbearing potential must take effective contraceptive measures during the treatment and for 6 months after the last dose of treatment.

Exclusion Criteria:

1. History of hypersensitivity to any component of MRG003.

2. Received chemotherapy, radiotherapy, biologicals, immunotherapy, or other anti-tumor drugs within 4 weeks prior to the first dose.

3. Presence of clinical manifestation of biliary obstruction.

4. Patients with clinical symptoms such as pleural, abdominal or pericardial effusion requiring puncture drainage.

5. Presence of central nervous system (CNS) metastasis and/or neoplastic meningitis.

6. Any severe or uncontrolled systemic diseases.

7. Patients with poorly controlled heart diseases.

8. Evidence of active infections, including but not limited to Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) infection.

9. History of other primary malignancies.

10. 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.

11. History of severe skin disease or chronic skin disease requiring oral or intravenous treatment.

12. History of interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.

13. Peripheral neuropathy greater than Grade 1.

14. 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.

15. History of cirrhosis (decompensated cirrhosis Child-Pugh class B and C).

16. Received anti-tumor vaccine treatment 4 weeks prior to the first dose or planning to participate in anti-tumor vaccine trials.

17. 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.

18. Other conditions inappropriate for participation in this clinical trial, at the discretion of the investigator.

Related Conditions & MeSH terms

• Advanced or Metastatic Biliary Tract Cancer
• Biliary Tract Neoplasms

Intervention

Drug:
• MRG003
Administrated intravenously

Locations

Country	Name	City	State
China	Beijing Youan Hospital,Capital Medical University	Beijing	Beijing
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing
China	Bethune First Hospital of Jilin University	Changchun	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Miracogen Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ORR by Investigator	ORR is defined as the percentage of patients with a CR and PR as assessed by Investigator according to RECIST v1.1.	Baseline to study completion, up to 12 months
Secondary	Duration of Response (DoR)	DOR is defined as the time from first documented objective response to the first onset of tumor progression or death of any cause.	Baseline to study completion, up to 12 months
Secondary	Time to Response (TTR)	TTR is defined as the duration from the start of treatment to the first onset of CR or PR in tumor evaluation.	Baseline to study completion, up to 12 months
Secondary	Disease Control Rate (DCR)	DCR is defined as the percentage of patients who achieve CR, PR, and stable disease (SD) after treatment.	Baseline to study completion, up to 12 months
Secondary	Progression Free Survival (PFS)	PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.	Baseline to study completion, up to 12 months
Secondary	Overall Survival (OS)	OS is defined as the duration from the start of treatment to death of any cause.	Baseline to study completion, up to 12 months
Secondary	Adverse Events (AEs)	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.	Baseline to 30 days after the last dose of study treatment
Secondary	Pharmacokinetics (PK) parameter of MRG003: concentration-time curve	Concentration-time curve will be depicted based on pharmacokinetics concentration set (PKCS).	Baseline to 30 days after the last dose of study treatment
Secondary	Incidence of anti-drug antibody (ADA)	The incidence of ADA analysis will be summarized for all patients who received at least one cycle study treatment.	Baseline to 30 days after the last dose of study treatment