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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04837508
• Other study ID #: MRG002-002
• Status: Recruiting
• Phase: Phase 2
• Start date: June 7, 2021
• Est. completion date: August 2023

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 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: August 2023
• Est. primary completion date: December 2022
• 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. HER2 positive (IHC 3 + or IHC 2 +) 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 MRG002 or history of hypersensitivity of = Grade 3 to trastuzumab.

2. Received chemotherapy, radiotherapy, biologicals, immunotherapy, or other anti-tumor drugs within 4 weeks prior to the first MRG002 treatment.

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

11. Peripheral neuropathy greater than Grade 1.

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

13. 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.

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

15. 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.

16. 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:
• MRG002
Administrated intravenously

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	The first affiliated hospital of bengbu medical college	Bengbu	Anhui
China	ZhuJiang Hospital of Southern Medical University	Guangzhou	Guangdong
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Liaoning Cancer Hospital&Institute	Shenyang	Liaoning
China	Henan Cancer Hospital	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 MRG002: 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