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
Overview
- Phase
- Phase 2
- Intervention
- MRG002
- Conditions
- Advanced or Metastatic Biliary Tract Cancer
- Sponsor
- Shanghai Miracogen Inc.
- Enrollment
- 86
- Locations
- 7
- Primary Endpoint
- Objective Response Rate (ORR) by Independent Review Committee (IRC)
- Last Updated
- 4 years ago
Overview
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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •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).
Exclusion Criteria
- •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.
Arms & Interventions
MRG002
MRG002 will be administrated by an IV infusion of 2.6 mg/kg on Day 1 of every 3 weeks (21-day cycle).
Intervention: MRG002
Outcomes
Primary Outcomes
Objective Response Rate (ORR) by Independent Review Committee (IRC)
Time Frame: Baseline to study completion, up to 12 months
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.
Secondary Outcomes
- 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)
- Overall Survival (OS)(Baseline to study completion, up to 12 months)
- Adverse Events (AEs)(Baseline to 30 days after the last dose of study treatment)
- Pharmacokinetics (PK) Parameter of MRG002: concentration-time curve(Baseline to 30 days after the last dose of study treatment)
- Incidence of anti-drug antibody (ADA)(Baseline to 30 days after the last dose of study treatment)