Advanced or Metastatic Biliary Tract CancerPhase 2NCT04837508
A Study of MRG002 in the Treatment of HER2-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer
A Phase 2 study testing MRG002 in people with Advanced or Metastatic Biliary Tract Cancer, run by Shanghai Miracogen Inc. at 7 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced or Metastatic Biliary Tract Cancer
- What is being tested?
- MRG002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 7 sitesChina
- Study dates
- 7 Jun 2021to Aug 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Other conditions inappropriate for participation in this clinical trial, at the discretion of the investigator.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100000
Aiping Zhou, MD, 86-10-87788800, zhouap1825@126.com
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Mei Guan, 010-69158353, guanmei71@126.com
- Recruiting
The first affiliated hospital of bengbu medical college
Bengbu, Anhui, 233004
Mingxi Wang, 0552-3086943, drwmx@126.com
- Recruiting
ZhuJiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280
Weimin Ding, 020-62783372, DWM-2001@163.com
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Yanqiao Zhang, 0451-86298192, yanqiaozhang@126.com
- Recruiting
Liaoning Cancer Hospital&Institute
Shenyang, Liaoning, 110801
Jingdong Zhang, 024-31916651, 13804027878@163.com
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Ying Liu, 0371-65588007, yaya7207@126.com
About this study
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
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.
Read the 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.
- Being tested
- MRG002
- Keywords
- MRG002, Antibody Drug Conjugate (ADC), HER2, Biliary Tract Cancer
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRG002Drug
Administrated intravenously
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: MRG002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to study completion, up to 12 months
Secondary outcomes (9)
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.
Measured: Baseline to study completion, up to 12 months
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.
Measured: Baseline to study completion, up to 12 months
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.
Measured: Baseline to study completion, up to 12 months
Disease Control Rate (DCR)
DCR is defined as the percentage of patients who achieve CR, PR, and stable disease (SD) after treatment.
Measured: Baseline to study completion, up to 12 months
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.
Measured: Baseline to study completion, up to 12 months
Overall Survival (OS)
OS is defined as the duration from the start of treatment to death of any cause.
Measured: Baseline to study completion, up to 12 months
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.
Measured: Baseline to 30 days after the last dose of study treatment
Pharmacokinetics (PK) Parameter of MRG002: concentration-time curve
Concentration-time curve will be depicted based on pharmacokinetics concentration set (PKCS).
Measured: Baseline to 30 days after the last dose of study treatment
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.
Measured: Baseline to 30 days after the last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start7 Jun 2021
- Primary completionDec 2022 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Biliary Tract CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Miracogen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aiping Zhou, MD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837508
- Sponsor's protocol ID
- MRG002-002
- Status last verified
- Dec 2021
- First submitted
- 6 Apr 2021
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04837508
- Acronym / sponsor ID
- MRG002-002
- Keywords
- MRG002, Antibody Drug Conjugate (ADC), HER2, Biliary Tract Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Shanghai Miracogen Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRG002 | Experimental | Drug: MRG002MRG002 will be administrated by an IV infusion of 2.6 mg/kg on Day 1 of every 3 weeks (21-day cycle). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRG002Administrated intravenously | Drug | MRG002 |
Primary outcome
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.
9 secondary outcomes
ORR by Investigator
Time frame: Baseline to study completion, up to 12 months
Duration of Response (DoR)
Time frame: Baseline to study completion, up to 12 months
Time to Response (TTR)
Time frame: Baseline to study completion, up to 12 months
Disease Control Rate (DCR)
Time frame: Baseline to study completion, up to 12 months
Progression Free Survival (PFS)
Time frame: Baseline to study completion, up to 12 months
Overall Survival (OS)
Time frame: Baseline to study completion, up to 12 months
Adverse Events (AEs)
Time frame: Baseline to 30 days after the last dose of study treatment
Pharmacokinetics (PK) Parameter of MRG002: concentration-time curve
Time frame: Baseline to 30 days after the last dose of study treatment
Incidence of anti-drug antibody (ADA)
Time frame: Baseline to 30 days after the last dose of study treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aiping Zhou, MD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MRG002 in people with Advanced or Metastatic Biliary Tract Cancer, run by Shanghai Miracogen Inc. at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Program Director (86-21-61637960, clinicaltrials@miracogen.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) by Independent Review Committee (IRC) (time frame: Baseline to study completion, up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2021.