Advanced MalignanciesPhase 1NCT04671875
A Clinical Study of MIL93 in Solid Tumors.
A Phase 1 study testing Recombinant Humanized Monoclonal Antibody MIL93 in people with Advanced Malignancies, run by Beijing Mabworks Biotech Co., Ltd. at 1 site in China.
Trial summary
MIL93 is a recombinant humanized anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody. This is an open label Phase I study to evaluate safety, tolerability, pharmacokinetics and efficacy of MIL93 in Advanced or Metastatic solid tumors. 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 MIL93
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteChina
- Study dates
- 21 Apr 2021to Aug 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
- Adult patients, >=18 years of age;
- Suffer from advanced unresectable or metastatic malignant solid tumors confirmed by histological diagnosis and meet the criteria of the enrolled group as follows:
- Mono-therapy dose escalation study: The subjects for whom no standard treatment regimens are available or who is intolerable to standard treatments.
- Mono-therapy dose expansion study: The subjects with positive CDLN18.2 expression in tumor tissue (through immunohistochemistry (IHC) test) confirmed by the central laboratory at enrollment.
- Combination study is composed of 2 cohorts.Cohort 1:Subjects with untreated CLDN18.2 positive G/GEJAC; Cohort 2:Subjects with untreated CLDN18.2 positive pancreatic cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
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- Life expectancy >=3 months;
- Sufficient organ and bone marrow function;
- At least one measurable lesion or evaluable lesion (recist v1.1);
- 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 CLDN 18.2;
- Major surgery within 8 weeks prior to the first administration or expected to undergo major surgery during the study treatment;
- Systemic immunosuppressive therapy was required within 14 days prior to the first administration;
- 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 );
- Suffering from serious or uncontrollable gastro-intestinal tract bleed;
- Known severe allergic reaction or/and infusion reaction to monoclonal antibody;
- 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 6 months after discontinuation of all study treatments.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing
Jing Huang, doctor, (+86)010-87788293, huangjingwg@163.com
About this study
Official title: A Phase I Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of MIL93 in Advanced or Metastatic Solid Tumors.
MIL93 is a recombinant humanized anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody. This is an open label Phase I study to evaluate safety, tolerability, pharmacokinetics and efficacy of MIL93 in Advanced or Metastatic solid tumors.
Read the detailed description
This study is composed of two stages:Part I is mono-therapy dose escalation and dose expansion study, and Part II is the study of combination therapy.
The dose escalation study will be conducted using Part I for testing optimal doses at 0.3,1, 3, 10, 20, 30 mg/kg every 3 weeks (Q3W). An accelerated titration followed by traditional 3+3 design will be used in this study with a 21-day dose-limiting toxicity (DLT) observation period. Based on the data of dose escalation study, determine whether to carry out dose escalation at frequency of every 2 weeks(Q2W) and how many cohorts will be added in dose expansion study.
Based on the data of Part I, one or two doses will be conducted in the study of combination therapy. The study of PART II is composed of two cohorts. Cohort 1:Subjects with untreated CLDN18.2 positive gastric/gastroesophageal junction adenocarcinoma(G/GEJAC) will be treated with MIL93 and standard first-line chemotherapy.Cohort 2:Subjects with untreated CLDN18.2 positive pancreatic cancer will be treated with MIL93 and standard first-line chemotherapy.
- Conditions
- Advanced Malignancies
- Being tested
- Recombinant Humanized Monoclonal Antibody MIL93
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Humanized Monoclonal Antibody MIL93Drug
PART I :The patients confirming to the eligibility criteria will be assigned to the 6 dose groups (0.3mg/kg, 1mg/kg, 3mg/kg, 10mg/kg, 20mg/kg, 30mg/kg,respectively) based on the sequence of inclusion. Each patient will receive an intravenous infusion of MIL93 every 3 or 2 week on Day 1.
PART II:One recommended dose will be conducted from 6 dose groups based on results of PART I.
| Study group | Role | What they receive |
|---|---|---|
| MIL93 | Experimental | Not described Receives: Drug: Recombinant Humanized Monoclonal Antibody MIL93 |
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 MIL93 in subjects with advanced malignancies.ORR includes complete remission(CR) and partial remission(PR) assessed by RECIST v1.1 criteria.
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 MIL93.
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 posted17 Dec 2020
- Study start21 Apr 2021
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (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
- 228 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
- NCT04671875
- Sponsor's protocol ID
- MIL93-CT101
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2020
- Last updated
- 13 Mar 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 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of MIL93 in Advanced or Metastatic Solid Tumors.
- ClinicalTrials.gov ID
- NCT04671875
- Acronym / sponsor ID
- MIL93-CT101
- Conditions
- Advanced Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Beijing Mabworks Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 17 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.
MIL93 is a recombinant humanized anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody. This is an open label Phase I study to evaluate safety, tolerability, pharmacokinetics and efficacy of MIL93 in Advanced or Metastatic solid tumors.
Detailed description
This study is composed of two stages:Part I is mono-therapy dose escalation and dose expansion study, and Part II is the study of combination therapy.
The dose escalation study will be conducted using Part I for testing optimal doses at 0.3,1, 3, 10, 20, 30 mg/kg every 3 weeks (Q3W). An accelerated titration followed by traditional 3+3 design will be used in this study with a 21-day dose-limiting toxicity (DLT) observation period. Based on the data of dose escalation study, determine whether to carry out dose escalation at frequency of every 2 weeks(Q2W) and how many cohorts will be added in dose expansion study.
Based on the data of Part I, one or two doses will be conducted in the study of combination therapy. The study of PART II is composed of two cohorts. Cohort 1:Subjects with untreated CLDN18.2 positive gastric/gastroesophageal junction adenocarcinoma(G/GEJAC) will be treated with MIL93 and standard first-line chemotherapy.Cohort 2:Subjects with untreated CLDN18.2 positive pancreatic cancer will be treated with MIL93 and standard first-line chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MIL93 | Experimental | Drug: Recombinant Humanized Monoclonal Antibody MIL93 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult patients, >=18 years of age;
- Suffer from advanced unresectable or metastatic malignant solid tumors confirmed by histological diagnosis and meet the criteria of the enrolled group as follows:
- Mono-therapy dose escalation study: The subjects for whom no standard treatment regimens are available or who is intolerable to standard treatments.
- Mono-therapy dose expansion study: The subjects with positive CDLN18.2 expression in tumor tissue (through immunohistochemistry (IHC) test) confirmed by the central laboratory at enrollment.
- Combination study is composed of 2 cohorts.Cohort 1:Subjects with untreated CLDN18.2 positive G/GEJAC; Cohort 2:Subjects with untreated CLDN18.2 positive pancreatic cancer.
Key exclusion criteria (11 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 CLDN 18.2;
- Major surgery within 8 weeks prior to the first administration or expected to undergo major surgery during the study treatment;
- Systemic immunosuppressive therapy was required within 14 days prior to the first administration;
- 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 MIL93PART I :The patients confirming to the eligibility criteria will be assigned to the 6 dose groups (0.3mg/kg, 1mg/kg, 3mg/kg, 10mg/kg, 20mg/kg, 30mg/kg,respectively) based on the sequence of inclusion. Each patient will receive an intravenous infusion of MIL93 every 3 or 2 week on Day 1. PART II:One recommended dose will be conducted from 6 dose groups based on results of PART I. | Drug | MIL93 |
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 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. 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 MIL93 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 10 inclusion and 11 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Huang, doctor ((+86)010-87788293, huangjingwg@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 13 Mar 2024; AzTrials last refreshed its copy on 2 Nov 2026.