Advanced MalignanciesPhase 1NCT04651348
A Clinical Study of MIL95 in Advanced Malignancies.
A Phase 1 study testing Recombinant Humanized Monoclonal Antibody MIL95 in people with Advanced Malignancies, run by Beijing Mabworks Biotech Co., Ltd. at 1 site in China.
Trial summary
This study is composed of two stages: Part A initial dose escalation and Part B maintenance dose escalation. Both parts will adopt the classical 3+3 dose escalation design. The starting dose for phase Ia part A is 0.1 mg/kg QW, followed by 3 dose cohorts (0.3mg/kg QW, 0.8mg/kg QW and 1mg/kg QW). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignancies
- What is being tested?
- Recombinant Humanized Monoclonal Antibody MIL95
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2021to Nov 2024
- 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
- Adult patients, >=18 years of age;
- Diagnosis of Refractory/relapsed lymphomas or solid tumor;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Life expectancy >=3 months;
- Sufficient organ and bone marrow function;
- At least one measurable lesion or evaluable lesion (recist v1.1 or Lugano 2014);
- Able and willing to provide written informed consent and to comply with the study protocol.
Who cannot join
- Prior use of any anti-cancer therapy(including chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc) within 4 weeks of study start;
- Previous exposure to any drug targeting CD47 or SIRPα;
- Major surgery within 4 weeks prior to the first administration or expected to undergo major surgery during the study treatment;
- Live attenuated vaccine administrated within 4 weeks before the first administration or during the study period;
- Central nervous system metastasis;
- History of other primary malignant tumors in 5 years;
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- Evidence of significant, uncontrolled concomitant disease;
- Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DNA or HCV RNA );
- Active or suspected autoimmune diseases;
- Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) while participating in the study; 2) for at least 12 months after discontinuation of all study treatments;
- Known history of hemolytic anemia;
- Known severe allergic reaction or/and infusion reaction to monoclonal antibody.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing
Yuqin Song, doctor
About this study
Official title: A Phase I Clinical Study of Recombinant Humanized Monoclonal Antibody MIL95 Injection in the Treatment of Lymphomas and Advanced Malignant Solid Tumors
This study is composed of two stages: Part A initial dose escalation and Part B maintenance dose escalation. Both parts will adopt the classical 3+3 dose escalation design.
The starting dose for phase Ia part A is 0.1 mg/kg QW, followed by 3 dose cohorts (0.3mg/kg QW, 0.8mg/kg QW and 1mg/kg QW). Duration of dose limiting toxicity (DLT) observation is 14 days.
Part B will have 5 dose cohorts(3mg/kg QW, 10mg/kg QW, 20mg/kg QW 30mg/kg QW and 45mg/kg QW). DLT observation period is 28 days. The subject number for each cohort in Part B will be increased to 6 if the subject number enrolled in each cohort is less than 6.
- Conditions
- Advanced Malignancies
- Being tested
- Recombinant Humanized Monoclonal Antibody MIL95
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Humanized Monoclonal Antibody MIL95Drug
PART A :The patients confirming to the eligibility criteria will be assigned to the 4 dose groups (0.1mg/kg, 0.3mg/kg, 0.8mg/kg, 1.0mg/kg, respectively) based on the sequence of inclusion. Each patient will receive an intravenous infusion of MIL95 every week on Day 1 for a maximum of Twelve weeks.
PART B:One recommended dose as a priming dose will be selected from 4 dose groups(0.1mg/kg、0.3mg/kg、0.8mg/kg、1.0mg/kg) based on results of PART A. Each patient will receive a priming dose of MIL95 on Day 1 Cycle 1.The patients will be assigned to the 5 maintenance dose groups (3mg/kg, 10mg/kg, 20mg/kg, 30mg/kg, 45mg/kg, respectively) based on the sequence of inclusion. The maintenance dose was given on Day 8,15,22 Cycle 1 and on Day 1,8,15,22 Cycle 2+. Each cycle was 28 days.
| Study group | Role | What they receive |
|---|---|---|
| MIL95 | Experimental | Not described Receives: Drug: Recombinant Humanized Monoclonal Antibody MIL95 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Adverse Events
Percentage of Participants with AEs and SAEs assessed by NCI CTCAE v5.0.
Measured: up to 1year after enrollment
Secondary outcomes (6)
Pharmacokinetics:AUC
The area under the curve (AUC) of serum concentration of the drug after the administration
Measured: up to 1year after enrollment
Pharmacokinetics: Cmax
Maximum concentration(Cmax) of the drug after administration
Measured: up to 1year after enrollment
Objective response rate (ORR)
To evaluate preliminary anti-tumor activity of MIL95 in subjects with advanced malignancies.ORR includes complete remission(CR) and partial remission(PR) assessed by RECIST v1.1 criteria for solid tumors and Lugano2014 criteria for lymphoma.
Measured: up to 1year after enrollment
Duration of response (DoR)
DOR is defined as the time from the initial response (CR or PR) to the time of disease progression or death, whichever occurs first.
Measured: up to 1year after enrollment
Progression free survival (PFS)
Defined as the time from the first day of study treatment to disease progression or death, whichever occurs first.
Measured: up to 1year after enrollment
Immunogenicity
Anti-Drug Antibodies (ADA) will be tested and percentage of ADA positive patients will be calculated to evaluate immunogenicity of MIL95.
Measured: up to 1year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start4 Jan 2021
- Primary completion8 Dec 2022
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MalignanciesStudies 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
- 58 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
- NCT04651348
- Sponsor's protocol ID
- MIL95-CT101
- Status last verified
- Jul 2024
- First submitted
- 11 Nov 2020
- Last updated
- 20 Nov 2024
- Results posted
- 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
- A Phase I Clinical Study of Recombinant Humanized Monoclonal Antibody MIL95 Injection in the Treatment of Lymphomas and Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT04651348
- Acronym / sponsor ID
- MIL95-CT101
- Conditions
- Advanced Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Beijing Mabworks Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 8 Dec 2022 (actual)
- Study completion
- Nov 2024 (estimated)
- First posted
- 3 Dec 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 study is composed of two stages: Part A initial dose escalation and Part B maintenance dose escalation. Both parts will adopt the classical 3+3 dose escalation design.
The starting dose for phase Ia part A is 0.1 mg/kg QW, followed by 3 dose cohorts (0.3mg/kg QW, 0.8mg/kg QW and 1mg/kg QW). Duration of dose limiting toxicity (DLT) observation is 14 days.
Part B will have 5 dose cohorts(3mg/kg QW, 10mg/kg QW, 20mg/kg QW 30mg/kg QW and 45mg/kg QW). DLT observation period is 28 days. The subject number for each cohort in Part B will be increased to 6 if the subject number enrolled in each cohort is less than 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MIL95 | Experimental | Drug: Recombinant Humanized Monoclonal Antibody MIL95 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patients, >=18 years of age;
- Diagnosis of Refractory/relapsed lymphomas or solid tumor;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Life expectancy >=3 months;
- Sufficient organ and bone marrow function;
Key exclusion criteria (12 listed)
- Prior use of any anti-cancer therapy(including chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc) within 4 weeks of study start;
- Previous exposure to any drug targeting CD47 or SIRPα;
- Major surgery within 4 weeks prior to the first administration or expected to undergo major surgery during the study treatment;
- Live attenuated vaccine administrated within 4 weeks before the first administration or during the study period;
- Central nervous system metastasis;
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 Monoclonal Antibody MIL95PART A :The patients confirming to the eligibility criteria will be assigned to the 4 dose groups (0.1mg/kg, 0.3mg/kg, 0.8mg/kg, 1.0mg/kg, respectively) based on the sequence of inclusion. Each patient will receive an intravenous infusion of MIL95 every week on Day 1 for a maximum of Twelve weeks. PART B:One recommended dose as a priming dose will be selected from 4 dose groups(0.1mg/kg、0.3mg/kg、0.8mg/kg、1.0mg/kg) based on results of PART A. Each patient will receive a priming dose of MIL95 on Day 1 Cycle 1.The patients will be assigned to the 5 maintenance dose groups (3mg/kg, 10mg/kg, 20mg/kg, 30mg/kg, 45mg/kg, respectively) based on the sequence of inclusion. The maintenance dose was given on Day 8,15,22 Cycle 1 and on Day 1,8,15,22 Cycle 2+. Each cycle was 28 days. | Drug | MIL95 |
Primary outcome
Percentage of Participants with Adverse Events
Time frame: up to 1year after enrollment
Percentage of Participants with AEs and SAEs assessed by NCI CTCAE v5.0.
6 secondary outcomes
Pharmacokinetics:AUC
Time frame: up to 1year after enrollment
Pharmacokinetics: Cmax
Time frame: up to 1year after enrollment
Objective response rate (ORR)
Time frame: up to 1year after enrollment
Duration of response (DoR)
Time frame: up to 1year after enrollment
Progression free survival (PFS)
Time frame: up to 1year after enrollment
Immunogenicity
Time frame: up to 1year after enrollment
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.
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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.
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 Monoclonal Antibody MIL95 in people with Advanced Malignancies, 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 7 inclusion and 12 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 Yuqin Song, doctor ((+86)010-88121122, songyuqin622@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Adverse Events (time frame: up to 1year after enrollment). 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.