HER2-positive Recurrent or Metastatic Malignant Solid TumorPhase 1NCT03842085
Phase I Clinical Study of MBS301 in Treatment of HER2 Positive Recurrent or Metastatic Malignant Solid Tumor
A Phase 1 study testing Recombinant Humanized Bispecific Monoclonal Antibody MBS301 in people with HER2-positive Recurrent or Metastatic Malignant Solid Tumor, run by Beijing Mabworks Biotech Co., Ltd. at 1 site in China.
Trial summary
This is a phase I study evaluating the safety and pharmacokinetics of MBS301 after intravenous administration in patients with HER-2 positive recurrent or metastatic malignant solid tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Recurrent or Metastatic Malignant Solid Tumor
- What is being tested?
- Recombinant Humanized Bispecific Monoclonal Antibody MBS301
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 11 Apr 2019to Dec 2025
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with HER2-positive recurrent or metastatic malignant solid tumor diagnosed by histopathology or cytology.
- Patients with any types of malignant solid tumors who have progressed despite standard therapy or are intolerant of standard therapy, or for which no standard therapy exists.
- Patients should have measurable lesions or immeasurable lesions (according to RECIST 1.1).
- ECOG physical condition: 0 or 1 point.
- Expected survival period exceeds 12 weeks.
Who cannot join
- Absolute neutrophils count (ANC) is less than1.5×109/L and/or blood platelets less than 100 ×109/L and/or hemoglobin less than 9g/dL.
- Total bilirubin is more than 1.5 ×ULN.
- Patients without hepatic metastasis, ALT or AST is more than 1.5 ×ULN; Patients with hepatic metastasis, ALT or AST is more than 3 ×ULN.
- Serum creatinine is more than 1.5 × ULN or estimated creatinine clearance <50 mL/min(according to Cockcroft-Gault).
- International normalized ratio (INR) is more than 1.5 × ULN or activated partial thromboplastin time (APTT) is more than 1.5 × ULN.
- Patient has prior treated with anthracyclineswhich accumulated dose is equivalent to adriamycin≥360mg/m2.
Show all 10Show fewer
- Patient has been experienced toxic reactions after previous anticancer therapy and has not recovered to Grade 0 or Grade 1 (except for hair loss).
- Known a history with brain metastasis.
- Have a history of liver disease of clinical significance.
- Known to be human immunodeficiency virus (HIV) positive.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hospital
Zhengzhou
Suxia Luo, doctor, luosxrm@163.com
About this study
Official title: Evaluation on Open-Labeled and Dose-Escalation Phase I Clinical Study of Safety and Pharmacokinetics of Recombinant Humanized Bispecific Monoclonal Antibody MBS301 for Injection in Treatment of HER2 Positive Recurrent or Metastatic Malignant Solid Tumor
This is a phase I study evaluating the safety and pharmacokinetics of MBS301 after intravenous administration in patients with HER-2 positive recurrent or metastatic malignant solid tumors
- Being tested
- Recombinant Humanized Bispecific Monoclonal Antibody MBS301
- Keywords
- HER2-positive, solid tumor, MBS301
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Humanized Bispecific Monoclonal Antibody MBS301Drug
Also called MBS301
The patients confirming to the eligibility criteria will be assigned to the 8 dose groups based on the sequence of inclusion. MBS301 will be administered intravenousely on day 1 of each 21-day cycle for each patient.The first intravenous infusion for each patient will be last for 90 minutes.It could be changed to 60 minutes for the subsequent infusions if the drug is well tolerated.
| Study group | Role | What they receive |
|---|---|---|
| MBS301 | Experimental | Drug: Recombinant Humanized Bispecific Monoclonal Antibody MBS301 Receives: Drug: Recombinant Humanized Bispecific Monoclonal Antibody MBS301 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT of MBS301
Evaluate the safety of MBS301 and determine the dose limited toxicity (DLT) .
Measured: up to the third treatment cycle of the last subject was ended (each cycle is 21 days)
MTD of MBS301
Evaluate the safety of MBS301 and determine the maximum tolerated dose (MTD).
Measured: up to the third treatment cycle of the last subject was ended (each cycle is 21 days)
Secondary outcomes (12)
Investigate the pharmacokinetics profile(Cmax) of MBS301
Maximum Plasma Concentration [Cmax]
Measured: At the end of Cycle 3 (each cycle is 21 days)
Investigate the pharmacokinetics profile(AUC) of MBS301
Area Under the Curve [AUC]
Measured: At the end of Cycle 3 (each cycle is 21 days)
Investigate the pharmacokinetics profile(Tmax) of MBS301
Time for Peak concentration[Tmax]
Measured: At the end of Cycle 3 (each cycle is 21 days)
Investigate the pharmacokinetics profile(MRT) of MBS301
Mean ResidenceTime[MRT]
Measured: At the end of Cycle 3 (each cycle is 21 days)
Investigate the pharmacokinetics profile(T1/2) of MBS301
Half-life[T1/2]
Measured: At the end of Cycle 3 (each cycle is 21 days)
Investigate the pharmacokinetics profile(Vd) of MBS301
Apparent volume of distribution[Vd]
Measured: At the end of Cycle 3 (each cycle is 21 days)
Investigate the pharmacokinetics profile(CL) of MBS301
Clearance[CL]
Measured: At the end of Cycle 3 (each cycle is 21 days)
Evaluate the immunogenicity of MBS301
Anti-drug antibody (ADA)
Measured: screening, before the second/third cycle of administration, Cycle 1 day 15, at the end of Cycle 3 (each cycle is 21 days)
Evaluate the objective response rate (ORR)of MBS301
objective response rate (ORR)
Measured: up to approximately 2 years
Evaluate the duration of response (DoR) of MBS301
duration of response (DoR)
Measured: up to approximately 2 years
Evaluate the disease control rate (DCR) of MBS301
disease control rate (DCR)
Measured: up to approximately 2 years
Evaluate the progression free survival (PFS) of MBS301
progression free survival (PFS)
Measured: up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start11 Apr 2019
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Recurrent or Metastatic Malignant Solid TumorStudies of the same condition, open and under way.
- More trials run by Beijing Mabworks Biotech Co., Ltd.The sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Mabworks Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842085
- Sponsor's protocol ID
- MBS301-CT01
- Status last verified
- Sep 2024
- First submitted
- 2 Feb 2019
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation on Open-Labeled and Dose-Escalation Phase I Clinical Study of Safety and Pharmacokinetics of Recombinant Humanized Bispecific Monoclonal Antibody MBS301 for Injection in Treatment of HER2 Positive Recurrent or Metastatic Malignant Solid Tumor
- ClinicalTrials.gov ID
- NCT03842085
- Acronym / sponsor ID
- MBS301-CT01
- Keywords
- HER2-positive, solid tumor, MBS301
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Beijing Mabworks Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 15 Feb 2019 (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.
This is a phase I study evaluating the safety and pharmacokinetics of MBS301 after intravenous administration in patients with HER-2 positive recurrent or metastatic malignant solid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MBS301 | Experimental | Drug: Recombinant Humanized Bispecific Monoclonal Antibody MBS301Drug: Recombinant Humanized Bispecific Monoclonal Antibody MBS301 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with HER2-positive recurrent or metastatic malignant solid tumor diagnosed by histopathology or cytology.
- Patients with any types of malignant solid tumors who have progressed despite standard therapy or are intolerant of standard therapy, or for which no standard therapy exists.
- Patients should have measurable lesions or immeasurable lesions (according to RECIST 1.1).
- ECOG physical condition: 0 or 1 point.
- Expected survival period exceeds 12 weeks.
Key exclusion criteria (10 listed)
- Absolute neutrophils count (ANC) is less than1.5×109/L and/or blood platelets less than 100 ×109/L and/or hemoglobin less than 9g/dL.
- Total bilirubin is more than 1.5 ×ULN.
- Patients without hepatic metastasis, ALT or AST is more than 1.5 ×ULN; Patients with hepatic metastasis, ALT or AST is more than 3 ×ULN.
- Serum creatinine is more than 1.5 × ULN or estimated creatinine clearance <50 mL/min(according to Cockcroft-Gault).
- International normalized ratio (INR) is more than 1.5 × ULN or activated partial thromboplastin time (APTT) is more than 1.5 × ULN.
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 |
|---|---|---|
| Recombinant Humanized Bispecific Monoclonal Antibody MBS301Also: MBS301The patients confirming to the eligibility criteria will be assigned to the 8 dose groups based on the sequence of inclusion. MBS301 will be administered intravenousely on day 1 of each 21-day cycle for each patient.The first intravenous infusion for each patient will be last for 90 minutes.It could be changed to 60 minutes for the subsequent infusions if the drug is well tolerated. | Drug | MBS301 |
Primary outcome
DLT of MBS301
Time frame: up to the third treatment cycle of the last subject was ended (each cycle is 21 days)
Evaluate the safety of MBS301 and determine the dose limited toxicity (DLT) .
MTD of MBS301
Time frame: up to the third treatment cycle of the last subject was ended (each cycle is 21 days)
Evaluate the safety of MBS301 and determine the maximum tolerated dose (MTD).
12 secondary outcomes
Investigate the pharmacokinetics profile(Cmax) of MBS301
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Investigate the pharmacokinetics profile(AUC) of MBS301
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Investigate the pharmacokinetics profile(Tmax) of MBS301
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Investigate the pharmacokinetics profile(MRT) of MBS301
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Investigate the pharmacokinetics profile(T1/2) of MBS301
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Investigate the pharmacokinetics profile(Vd) of MBS301
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Investigate the pharmacokinetics profile(CL) of MBS301
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Evaluate the immunogenicity of MBS301
Time frame: screening, before the second/third cycle of administration, Cycle 1 day 15, at the end of Cycle 3 (each cycle is 21 days)
Evaluate the objective response rate (ORR)of MBS301
Time frame: up to approximately 2 years
Evaluate the duration of response (DoR) of MBS301
Time frame: up to approximately 2 years
Evaluate the disease control rate (DCR) of MBS301
Time frame: up to approximately 2 years
Evaluate the progression free survival (PFS) of MBS301
Time frame: up to approximately 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
Related trials for HER2-positive Recurrent or Metastatic Malignant Solid Tumor
RecruitingPhase 1
Personalized Neo-Antigen Peptide Vaccine for the Treatment of Stage IIIC-IV Melanoma, Hormone Receptor Positive HER2 Negative Metastatic Refractory Breast Cancer or Stage III-IV Non-Small Cell Lung Cancer
Anatomic Stage IV Breast Cancer AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant Humanized Bispecific Monoclonal Antibody MBS301 in people with HER2-positive Recurrent or Metastatic Malignant Solid Tumor, run by Beijing Mabworks Biotech Co., Ltd. at 1 site 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 5 inclusion and 10 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 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Suxia Luo, doctor (18638553211, luosxrm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT of MBS301 (time frame: up to the third treatment cycle of the last subject was ended (each cycle is 21 days)). The study lists 2 primary outcomes in all. 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 20 Nov 2024.