Advanced or Metastatic Solid TumorPhase 1NCT04965077
Treatment of Advanced and Metastatic Solid Tumors With MIL97
A Phase 1 study testing Recombinant Humanized Monoclonal Antibody MIL97 for Injection in people with Advanced or Metastatic Solid Tumor, run by Beijing Mabworks Biotech Co., Ltd. at 1 site in China.
Trial summary
This is a Phase 1, global, multi-center, open-label, multiple-dose, first-in-human study of MIL97 to evaluate the safety, tolerability, pharmacokinetics, biomarkers and efficacy in subjects with advanced or metastatic solid tumor. The study consists of a dose escalation phase and a dose expansion phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Tumor
- What is being tested?
- Recombinant Humanized Monoclonal Antibody MIL97 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2022to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 metastatic and/or unresectable solid tumors;
- At least one extracranial measurable unirradiated lesion or evaluable lesion (recist v1.1) ;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1Life expectancy >=3 months;
- Sufficient organ and bone marrow function within 7 days before enrollment;
- Life expectancy >=12 weeks;
- Able and willing to provide written informed consent and to comply with the study protocol.
Who cannot join
- have a history of myocardial infarction within 6 months or a history of arterial thromboembolic event within 3 months before the first dose;
- Comorbidity that would interfere with therapy, including interstitial pneumonia, symptomatic congestive heart failure; unstable angina, uncontrolled hypertension; ongoing cardiac arrhythmia ≥ CTCAE 5.0 Grade 3, active coagulopathy, uncontrolled diabetes, QTcF>450ms (Male) or QTcF>470ms (Female) at screening;
- Patients have a known or suspected history of an autoimmune disorder, except for the following: Type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders such as vitiligo, or alopecia not requiring systemic therapy, or conditions not expected to recur in the absence of an external trigger are eligible;
- Have a history of manifested central nervous system (CNS) metastases or have primary brain tumor. Patients with known or suspected leptomeningeal disease or cord compression;
- Receipt of allograft or allogeneic hematopoietic stem cell transplantation;
- Patients have another active invasive malignancy, but history of a non-invasive malignancy and history of malignancy that is in complete remission after treatment with curative intent are allowed;
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- Active known clinically serious infections are required intravenous antibiotic treatment;
- Have a history of primary immunodeficiency, including but not limited with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness;
- Active and clinical significant bacterial, fungal, or viral infection including hepatitis B virus (HBV) or hepatitis C (HCV) (Hepatitis B should be confirmed as HBV surface antigen (HBsAg) positive or HBV core antibody (HBcAb) positive with HBV DNA above ULN);
- Any antitumor therapy within prior 4 weeks (including chemotherapy, targeted therapy, hormone therapy, immunotherapy, radiotherapy, tumor embolization, etc), except for palliative radiotherapy for relief bone pain;
- Major surgery within prior 4 weeks or expected to require major surgery during study treatment (Major surgery: laparotomy, thoracotomy, and internal organs excision by laparoscopic surgery);
- Patients have concurrent received or used an immunosuppressive agent within 14 days before study treatment, with the following exceptions and notes: Systemic steroids at physiologic doses, intranasal, inhaled, topical, intra-articular, and ocular corticosteroids with minimal systemic absorption, transient courses of steroids may be approved by the Medical Monitor;
- Previous exposure to CD40 antibodies;
- Patients received a live attenuated vaccine within 28 days before study treatment and plan to receive live vaccines during the study unless approved by both investigator and sponsor;
- Toxicities due to prior therapy are unresolved to ≤ CTCAE 5.0 Grade 1 except for AEs not constituting a safety risk to the patient based on the judgment of investigators;
- History of clinically significant sensitivity or allergy to MIL97, their excipients, or intravenous gamma globulin;
- Females who are pregnant or lactating or who intend to become pregnant during the clinical trial period and within 6 months after discontinuation of study treatment. Female or Male who refused using birth control during the clinical trial period and within 6 months after discontinuation of study treatment;
- Participation in a therapeutic clinical study within 4 weeks for biological treatments, and within 1 week or 5 half-lives for small-molecule agents, before study drug treatment, or current participation in other therapeutic investigational procedures;
- Patients who have any clinically significant psychiatric, social, or medical condition that, in the opinion of the investigator, could increase the patient's risk, interfere with protocol adherence, or affect the patient's ability to give informed consent are ineligible to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Jianming Xu, doctor
About this study
Official title: A Phase I Multicenter, Open Label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of MIL97 in Subjects With Advanced or Metastatic Solid Tumors
This is a Phase 1, global, multi-center, open-label, multiple-dose, first-in-human study of MIL97 to evaluate the safety, tolerability, pharmacokinetics, biomarkers and efficacy in subjects with advanced or metastatic solid tumor. The study consists of a dose escalation phase and a dose expansion phase. An accelerated titration design (cohorts 1-2 only) followed by 3+3 dose-escalation design will be used in dose escalation phase.
The starting dose for dose escalation phase is 0.01 mg/kg Q3W, followed by 5 dose cohorts (0.03mg/kg Q3W, 0.1mg/kg Q3W, 0.2mg/kg Q3W, 0.3mg/kg Q3W and 0.45mg/kg Q3W). Duration of dose limiting toxicity (DLT) observation is 21 days. Based on data of 3-week treatment regimen, one or two dose levels may be chosen for Q2w regimen. Duration of dose limiting toxicity (DLT) observation is 28 days.
One or two dose cohorts will be chosen (either 2-week regimen or 3-week regimen cohorts) to expand to total of 10 subjects in each cohort for further exploration of PK as well as safety and efficacy.
- Conditions
- Advanced or Metastatic Solid Tumor
- Being tested
- Recombinant Humanized Monoclonal Antibody MIL97 for Injection
- 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 Monoclonal Antibody MIL97 for InjectionDrug
Dose escalation phase: The patients confirming to the eligibility criteria will be assigned to the 6 dose groups (0.01mg/kg, 0.03mg/kg, 0.1mg/kg, 0.2mg/kg, 0.3mg/kg 0.45mg/kg, respectively) based on the sequence of inclusion. Each patient will receive an intravenous infusion of MIL97 every 3 week on Day 1 of each cycle. Additional 1 or 2 dose cohorts will receive an intravenous infusion of MIL97 every 2 week on Day 1 of each cycle after last patient finishes DLT observation period.
Dose expansion phase: One or two recommended expansion doses (either Q3W or Q2W) will be selected from 6 dose groups (0.01mg/kg, 0.03mg/kg, 0.1mg/kg, 0.2mg/kg, 0.3mg/kg 0.45mg/kg) based on results of dose escalation phase. MIL97 will be administered via intravenous infusion for 60 to 90 minutes on Day 1 of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| MIL97 | Experimental | Not described Receives: Drug: Recombinant Humanized Monoclonal Antibody MIL97 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of MIL97 treatment-emergent adverse events in patients with advanced or metastatic solid tumor
incidence of AEs and SAEs assessed by NCI CTCAE v5.0.
Measured: up to 2.5 year after enrollment
Secondary outcomes (9)
Pharmacokinetics: AUC
The area under the curve (AUC) of serum concentration of the drug after the administration
Measured: up to 1.5 year after enrollment
Pharmacokinetics: Cmax;
Maximum concentration (Cmax) of the drug after administration
Measured: up to 1.5 year after enrollment
Objective response rate (ORR);
To evaluate preliminary anti-tumor activity of MIL97 in subjects with advanced or metastatic solid tumor. ORR includes complete remission (CR) and partial remission (PR) assessed by RECIST v1.1 criteria.
Measured: up to 2.5 year 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 2.5 year 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 2.5 year after enrollment
The overall survival for patients with advanced or metastatic solid tumor;
Defined as the time from the first day of study treatment to disease progression or death, whichever occurs first.
Measured: up to 2.5 year after enrollment
The Disease control rate for patients with advanced or metastatic solid tumor;
Defined defined as the proportion of patients with objective evidence of CR, PR, or SD.
Measured: up to 2.5 year after enrollment
Immunogenicity;
Anti-Drug Antibodies (ADA) will be tested and percentage of ADA positive patients will be calculated to evaluate immunogenicity of MIL97.
Measured: up to 2.5 year after enrollment
Biomarkers;
measurement of CD80, CD86 and cytokines in human plasma
Measured: up to 2.5 year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start18 Jan 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (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 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 62 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
- NCT04965077
- Sponsor's protocol ID
- MIL97-CT101
- Status last verified
- Dec 2023
- First submitted
- 7 Jul 2021
- Last updated
- 13 Mar 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 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Multicenter, Open Label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of MIL97 in Subjects With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT04965077
- Acronym / sponsor ID
- MIL97-CT101
- Conditions
- Advanced or Metastatic Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Beijing Mabworks Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Jul 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.
This is a Phase 1, global, multi-center, open-label, multiple-dose, first-in-human study of MIL97 to evaluate the safety, tolerability, pharmacokinetics, biomarkers and efficacy in subjects with advanced or metastatic solid tumor. The study consists of a dose escalation phase and a dose expansion phase. An accelerated titration design (cohorts 1-2 only) followed by 3+3 dose-escalation design will be used in dose escalation phase.
The starting dose for dose escalation phase is 0.01 mg/kg Q3W, followed by 5 dose cohorts (0.03mg/kg Q3W, 0.1mg/kg Q3W, 0.2mg/kg Q3W, 0.3mg/kg Q3W and 0.45mg/kg Q3W). Duration of dose limiting toxicity (DLT) observation is 21 days. Based on data of 3-week treatment regimen, one or two dose levels may be chosen for Q2w regimen. Duration of dose limiting toxicity (DLT) observation is 28 days.
One or two dose cohorts will be chosen (either 2-week regimen or 3-week regimen cohorts) to expand to total of 10 subjects in each cohort for further exploration of PK as well as safety and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MIL97 | Experimental | Drug: Recombinant Humanized Monoclonal Antibody MIL97 for Injection |
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 metastatic and/or unresectable solid tumors;
- At least one extracranial measurable unirradiated lesion or evaluable lesion (recist v1.1) ;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1Life expectancy >=3 months;
- Sufficient organ and bone marrow function within 7 days before enrollment;
Key exclusion criteria (19 listed)
- have a history of myocardial infarction within 6 months or a history of arterial thromboembolic event within 3 months before the first dose;
- Comorbidity that would interfere with therapy, including interstitial pneumonia, symptomatic congestive heart failure; unstable angina, uncontrolled hypertension; ongoing cardiac arrhythmia ≥ CTCAE 5.0 Grade 3, active coagulopathy, uncontrolled diabetes, QTcF>450ms (Male) or QTcF>470ms (Female) at screening;
- Patients have a known or suspected history of an autoimmune disorder, except for the following: Type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders such as vitiligo, or alopecia not requiring systemic therapy, or conditions not expected to recur in the absence of an external trigger are eligible;
- Have a history of manifested central nervous system (CNS) metastases or have primary brain tumor. Patients with known or suspected leptomeningeal disease or cord compression;
- Receipt of allograft or allogeneic hematopoietic stem cell transplantation;
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 MIL97 for InjectionDose escalation phase: The patients confirming to the eligibility criteria will be assigned to the 6 dose groups (0.01mg/kg, 0.03mg/kg, 0.1mg/kg, 0.2mg/kg, 0.3mg/kg 0.45mg/kg, respectively) based on the sequence of inclusion. Each patient will receive an intravenous infusion of MIL97 every 3 week on Day 1 of each cycle. Additional 1 or 2 dose cohorts will receive an intravenous infusion of MIL97 every 2 week on Day 1 of each cycle after last patient finishes DLT observation period. Dose expansion phase: One or two recommended expansion doses (either Q3W or Q2W) will be selected from 6 dose groups (0.01mg/kg, 0.03mg/kg, 0.1mg/kg, 0.2mg/kg, 0.3mg/kg 0.45mg/kg) based on results of dose escalation phase. MIL97 will be administered via intravenous infusion for 60 to 90 minutes on Day 1 of each cycle. | Drug | MIL97 |
Primary outcome
The incidence of MIL97 treatment-emergent adverse events in patients with advanced or metastatic solid tumor
Time frame: up to 2.5 year after enrollment
incidence of AEs and SAEs assessed by NCI CTCAE v5.0.
9 secondary outcomes
Pharmacokinetics: AUC
Time frame: up to 1.5 year after enrollment
Pharmacokinetics: Cmax;
Time frame: up to 1.5 year after enrollment
Objective response rate (ORR);
Time frame: up to 2.5 year after enrollment
Duration of response (DoR);
Time frame: up to 2.5 year after enrollment
Progression free survival (PFS);
Time frame: up to 2.5 year after enrollment
The overall survival for patients with advanced or metastatic solid tumor;
Time frame: up to 2.5 year after enrollment
The Disease control rate for patients with advanced or metastatic solid tumor;
Time frame: up to 2.5 year after enrollment
Immunogenicity;
Time frame: up to 2.5 year after enrollment
Biomarkers;
Time frame: up to 2.5 year after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 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.
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 MIL97 for Injection in people with Advanced or Metastatic 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 7 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 13 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianming Xu, Ph.D (13910866712, jmxu2003@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of MIL97 treatment-emergent adverse events in patients with advanced or metastatic solid tumor (time frame: up to 2.5 year 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 13 Mar 2024.