Advanced Solid TumorPhase 1NCT04478461
Safety, Tolerability, and Pharmacokinetics of MW11 in Patients With Advanced Solid Tumors
A Phase 1 study testing PD-1 monoclonal antibody in people with Advanced Solid Tumor, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
Trial summary
This is a phase Ia, single-center, open label, dose escalation clinical study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and anti-tumor efficacy of MW11 (a recombinant humanized anti-PD-1 monoclonal antibody) for injection in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- PD-1 monoclonal antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2020to 2 Feb 2023
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged from 18 to 75 (including 18 and 75).
- Pathological diagnosis of advanced or metastatic solid tumors.
- Advanced solid tumors that are progressed after standard antitumor therapy and can not accept or refuse to receive standard treatment.
- The ECOG score is 0 or 1.
- The subjects are expected to survive at least 3 months.
- Subjects must have at least 1 measurable lesion according to response evaluation criteria in solid tumors RECIST V1.1. The measurable lesion must be absent from the previous radiotherapy area or have progressed radiologically 4 weeks after radiotherapy.
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- The subjects have proper organ and hematopoietic function, no serious heart, lung, liver, renal function abnormalities or immune deficiency according to the following laboratory tests:
- Hematology: Absolute neutrophils count (ANC) ≥ 1.5×109/L, platelet ≥ 100×109/L, hemoglobin ≥ 90g/L.
- Renal function: serum creatinine ≤ 1.5 times the upper limit of normal value (ULN) or creatinine clearance ≥ 50 mL/ min (Chockcroft-Gault formula was used for creatinine clearance).
- Liver function: AST and ALT ≤ 2.5 times ULN(AST and ALT ≤ 5 times ULN in patients with liver cancer or liver metastasis; serum total bilirubin (TBIL) ≤ 1.5 times ULN; alkaline phosphatase ≤ 1.5 times ULN(alkaline phosphatase≤ 5 times ULN in patients with liver cancer or liver metastasis, or patients with bone metastasis).
- Coagulation function: international normalized ratio (INR) ≤ 2 times ULN, or activated partial thromboplastin time (APTT) ≤ 1.5 times ULN (except for the subjects who are receiving anticoagulant therapy).
- Male subjects with fertility and female subjects of reproductive age are willing to take effective contraceptive measures from the signing of informed consent until 6 months after the last dose of drug administration. Female subjects of reproductive age (before menopause and women after menopause within 2 years) must have negative blood pregnancy test results within 7 days before the first drug administration.
- Subjects sign informed consent voluntarily, to make sure they understand the study and are willing to follow and able to complete all trial procedures.
Who cannot join
- Prior or current medical conditions:
- Previous history of other malignant tumors (any malignant tumor other than the tumor species treated in this study), except that the tumor has been cured for ≥ 2 years before screening and treatment is not required during the study period.
- Brain metastases.
- Prior adverse reactions failed to recover to CTCAE V5.0 grade score ≤ 1, with the exception of residual hair loss effect.
- Fluid accumulations in the body cavity (pleural effusion, ascites, pericardial effusion, etc.) that are not well controlled and require local treatment or repeated drainage.
- With active, or history of autoimmune diseases that may recur (E.G. systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.) , or high-risk patients, such as those who have received an organ transplant and require immunosuppressive therapy. But subjects with the following diseases are allowed to be enrolled:
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- Subjects with type I diabetes whose condition is stable after receiving fixed dose of insulin (HgbA1C ≤ 6.5%).
- Autoimmune hypothyroidism requiring only hormone replacement therapy. Vitiligo, or skin diseases that do not require systemic treatment (such as eczema that accounts for less than 10% of the body surface, psoriasis without ophthalmic symptoms, etc.).
- Sudden onset of pulmonary disease, Interstitial lung disease or pneumonia, or other uncontrolled systemic disease including diabetes, pulmonary fibrosis, acute lung disease, cardiovascular disease including hypertension (for example, LVEF ≤50% or NYHA ≥ III) , with the exception of locally interstitial pneumonia due to radiotherapy.
- Subjects infected by human immunodeficiency virus (HIV), or with other acquired or congenital immunodeficiency diseases, or with a history of organ transplantation or stem cell transplantation.
- Subjects with active tuberculosis infection within 5 years before enrollment.
- Subjects who were seriously infected within 4 weeks prior to the first drug administration, or who had any signs or symptoms of active infection within 2 weeks priorly, or who required antibiotic treatment within 2 weeks priorly (except for the prophylactic antibiotics); or patients who had unexplained fever >38.5℃ before the first drug administration (subject with fever caused by tumor can be enrolled according to the investigator's judgment).
- Prior medication or treatment:
- Patients who have received anti-PD-1 or PD-L1 antibody therapy or have received any other antibody/drug (such as CTLA-4) therapy targeting T-cell co-regulatory proteins (immune checkpoint) within 12 weeks prior to the first drug administration of the study.
- Subjects who have received anti-tumor therapy except:
- The interval between systemic radiotherapy and the first drug administration of this study is ≥ 4 weeks, and the interval of local or bone metastasis radiotherapy is ≥ 2 weeks. No radiological agents were taken within 8 weeks prior to the first drug administration of this study.
- Prior chemotherapy interval ≥ 4 weeks, immunotherapy, biological therapy (tumor vaccine, cytokines, or growth factors that control cancer), or approved targeted and other therapies, must be completed before the first drug administration in this study, and the interval must be no less than 5 half-lives or at least 6 weeks (whichever is longer).
- TCM treatment should be completed at least 14 days before the first drug administration in this study.
- Subjects require systemic corticosteroids (the dosage is equivalent to >10 mg prednisone per day) or other immunosuppressive drugs within 14 days prior to enrollment. Enrollment is allowed in the following cases:
- Subjects are allowed to use topical or inhaled glucocorticoids. Subjects are allowed to use glucocorticoids in short-term (≤ 7 days) for the prevention or treatment of non-autoimmune allergic diseases that do not occur frequently.
- Subjects who have received immunotherapy and had an immune-related adverse event (irAE) level ≥ 3.
- History of allergies, general conditions and others:
- A subject is known to have had a prior severe allergic reaction to a macromolecular protein preparation/monoclonal antibody or any component of the tested drug (CTCAE V5.0 rating is greater than level 3).
- Subjects with chronic hepatitis B/ active hepatitis C/ syphilis. However, hepatitis B virus carriers, stable hepatitis B after drug treatment (DNA ≤ normal value), and cured hepatitis C patients (HCV RNA negative) can be enrolled.
- Subjects who participated in other drug clinical trials within 4 weeks prior to enrollment.
- Subjects who had major surgery within 4 weeks prior to screening or who are expected to have major surgery during the study period (including the 28-day screening period).
- Subjects with history of alcohol, drug or substance abuse in the last 1 year.
- Subjects with clear history of neurological or psychiatric disorders, such as epilepsy, dementia, or poor compliance.
- Females who are pregnant or breastfeeding.
- Subjects with any other medical condition that is considered to affect the subject's safety.
- The subjects that the investigator considers unsuitable for the study due to other reasons.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Suxia Luo
About this study
Official title: A Phase Ia Clinical Trial to Assess Safety, Tolerability, and Pharmacokinetics of a Recombinant Humanized Anti-PD-1 Monoclonal Antibody (MW11) for Injection in Patients With Advanced Solid Tumors
This is a phase Ia, single-center, open label, dose escalation clinical study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and anti-tumor efficacy of MW11 (a recombinant humanized anti-PD-1 monoclonal antibody) for injection in patients with advanced solid tumors.
Read the detailed description
The enrollment mainly depends on "3+3" principle. A total of 3 or 4 dose groups will be evaluated during the dose escalation period: 1, 3, 10 mg/kg, and maybe an additional fixed dose (e.g., to evaluate 200 mg or other fixed dose as RP2D). The drug is scheduled to be administrated Q3W. Actual dose increments or dosing frequency may be adjusted according to PK data and safety of MW11. Safety, tolerability, and DLT will be assessed within 3 weeks (21 days) after initial administration. Anti-tumor efficacy will be assessed every 6 weeks during the first 24 weeks and every 12 weeks ever since. The study will be divided into screening period and treatment period. The drug administration will be continued until the investigators consider that the subjects will no longer benefit from the treatment, or the subjects meet intolerable toxicity, or the subjects withdraw the informed consent, or disease progression occurs.
- Conditions
- Advanced Solid Tumor
- Being tested
- PD-1 monoclonal antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 monoclonal antibodyDrug
Also called MW11 injection
The enrollment mainly depends on "3+3" principle. A total of 3 or 4 dose groups will be evaluated during the dose escalation period: 1, 3, 10 mg/kg, and maybe an additional fixed dose (e.g., to evaluate 200 mg or other fixed dose as RP2D). The drug is scheduled to be administrated Q3W
| Study group | Role | What they receive |
|---|---|---|
| MW11 injection | Experimental | 1, 3, 10 mg/kg and maybe an additional fixed dose (e.g., to evaluate 200 mg or other fixed dose as RP2D). The drug is scheduled to be administrated Q3W. Receives: Drug: PD-1 monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event (AE )
safety evaluation
Measured: 2 years
Severity Adverse Event (SAE)
safety evaluation
Measured: 2 years
Secondary outcomes (13)
Elimination half life（t1/2）
safety/efficacy evaluation
Measured: 2 years
Area under the concentration-time curve（AUC）
safety/efficacy evaluation
Measured: 2 years
volume of distribution （Vz）
safety/efficacy evaluation
Measured: 2 years
Plasma Clearance （CL）
safety/efficacy evaluation
Measured: 2 years
Maximum Plasma Concentration（Cmax）
safety/efficacy evaluation
Measured: 2 years
Time to maximum plasma concentration（Tmax）
safety/efficacy evaluation
Measured: 2 years
Objective remission rate (ORR)
efficacy evaluation
Measured: 2 years
Disease control rate (DCR)
efficacy evaluation
Measured: 2 years
Duration of remission (DOR)
efficacy evaluation
Measured: 2 years
Progression free survival (PFS)
efficacy evaluation
Measured: 2 years
Overall survival (OS)
efficacy evaluation
Measured: 2 years
Number of Participants with positive anti drug antibody (ADA)
safety evaluation
Measured: 2 years
Number of Participants with positive neutralizing antibody (Nab)
safety evaluation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start3 Sep 2020
- Primary completion5 Jan 2023 (estimated)
- Study completion2 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Mabwell (Shanghai) Bioscience 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
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suxia Luo, professor, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478461
- Sponsor's protocol ID
- MW11-2019-CP101
- Status last verified
- Nov 2020
- First submitted
- 14 Jul 2020
- Last updated
- 13 Nov 2020
- 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 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia Clinical Trial to Assess Safety, Tolerability, and Pharmacokinetics of a Recombinant Humanized Anti-PD-1 Monoclonal Antibody (MW11) for Injection in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04478461
- Acronym / sponsor ID
- MW11-2019-CP101
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- 5 Jan 2023 (estimated)
- Study completion
- 2 Feb 2023 (estimated)
- First posted
- 20 Jul 2020 (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 Ia, single-center, open label, dose escalation clinical study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and anti-tumor efficacy of MW11 (a recombinant humanized anti-PD-1 monoclonal antibody) for injection in patients with advanced solid tumors.
Detailed description
The enrollment mainly depends on "3+3" principle. A total of 3 or 4 dose groups will be evaluated during the dose escalation period: 1, 3, 10 mg/kg, and maybe an additional fixed dose (e.g., to evaluate 200 mg or other fixed dose as RP2D). The drug is scheduled to be administrated Q3W. Actual dose increments or dosing frequency may be adjusted according to PK data and safety of MW11. Safety, tolerability, and DLT will be assessed within 3 weeks (21 days) after initial administration. Anti-tumor efficacy will be assessed every 6 weeks during the first 24 weeks and every 12 weeks ever since. The study will be divided into screening period and treatment period. The drug administration will be continued until the investigators consider that the subjects will no longer benefit from the treatment, or the subjects meet intolerable toxicity, or the subjects withdraw the informed consent, or disease progression occurs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MW11 injection | Experimental | Drug: PD-1 monoclonal antibody1, 3, 10 mg/kg and maybe an additional fixed dose (e.g., to evaluate 200 mg or other fixed dose as RP2D). The drug is scheduled to be administrated Q3W. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Men and women aged from 18 to 75 (including 18 and 75).
- Pathological diagnosis of advanced or metastatic solid tumors.
- Advanced solid tumors that are progressed after standard antitumor therapy and can not accept or refuse to receive standard treatment.
- The ECOG score is 0 or 1.
- The subjects are expected to survive at least 3 months.
Key exclusion criteria (31 listed)
- Previous history of other malignant tumors (any malignant tumor other than the tumor species treated in this study), except that the tumor has been cured for ≥ 2 years before screening and treatment is not required during the study period.
- Brain metastases.
- Prior adverse reactions failed to recover to CTCAE V5.0 grade score ≤ 1, with the exception of residual hair loss effect.
- Fluid accumulations in the body cavity (pleural effusion, ascites, pericardial effusion, etc.) that are not well controlled and require local treatment or repeated drainage.
- With active, or history of autoimmune diseases that may recur (E.G. systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.) , or high-risk patients, such as those who have received an organ transplant and require immunosuppressive therapy. But subjects with the following diseases are allowed to be enrolled:
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 |
|---|---|---|
| PD-1 monoclonal antibodyAlso: MW11 injectionThe enrollment mainly depends on "3+3" principle. A total of 3 or 4 dose groups will be evaluated during the dose escalation period: 1, 3, 10 mg/kg, and maybe an additional fixed dose (e.g., to evaluate 200 mg or other fixed dose as RP2D). The drug is scheduled to be administrated Q3W | Drug | MW11 injection |
Primary outcome
Adverse Event (AE )
Time frame: 2 years
safety evaluation
Severity Adverse Event (SAE)
Time frame: 2 years
safety evaluation
13 secondary outcomes
Elimination half life（t1/2）
Time frame: 2 years
Area under the concentration-time curve（AUC）
Time frame: 2 years
volume of distribution （Vz）
Time frame: 2 years
Plasma Clearance （CL）
Time frame: 2 years
Maximum Plasma Concentration（Cmax）
Time frame: 2 years
Time to maximum plasma concentration（Tmax）
Time frame: 2 years
Objective remission rate (ORR)
Time frame: 2 years
Disease control rate (DCR)
Time frame: 2 years
Duration of remission (DOR)
Time frame: 2 years
Progression free survival (PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Number of Participants with positive anti drug antibody (ADA)
Time frame: 2 years
Number of Participants with positive neutralizing antibody (Nab)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
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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.
Suxia Luo, professor principal investigator
Henan Cancer Hospital
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 PD-1 monoclonal antibody in people with Advanced Solid Tumor, run by Mabwell (Shanghai) Bioscience 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 13 inclusion and 31 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 13 Nov 2020. 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 Shan An (13613865536, watermelonas@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event (AE ) (time frame: 2 years). 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 13 Nov 2020.