Advanced Unresectable Solid TumorsPhase 1NCT04894825
Safety, Tolerability and Pharmacokinetic Profile of M108 Monoclonal Antibody in Patients With Advanced Unresectable Solid Tumors in China
A Phase 1 study testing M108 in people with Advanced Unresectable Solid Tumors, run by FutureGen Biopharmaceutical (Beijing) Co., Ltd at 1 site in China.
Trial summary
M108 is a monoclonal antibody specific for gastric and gastroesophageal adenocarcinomas. The aim of this phase I study is to establish safety and Tolerability of different Dosage regimen in patients With Advanced Unresectable Solid Tumors in China. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Unresectable Solid Tumors
- What is being tested?
- M108
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteChina
- Study dates
- 11 Jun 2021to 30 Dec 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent.
- Advanced Unresectable solid tumors proven by histology
- At least 1 measurable site of the disease according RECIST 1.1 criteria
- ECOG performance status (PS) 0-1
- Life expectancy > 3 months
- Age ≥ 18 years and ≤75 years
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- Adequate haematological function; absolute neutrophil count ≥1.5 x 109/L; white blood cell count ≥3.0 x 109/L; platelets ≥100 x 109/L; haemoglobin ≥9 g/dL.
- Adequate coagulation function; international normalized ratio ( INR) ≤ 1.5 x upper limit of normal (ULN), or activated partial thromboplastin time (APTT) ≤ 1.5 x ULN.
- Adequate hepatic function; bilirubin ≤1.5 x ULN, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤2.5 x ULN.
- Adequate renal function; creatinine ≤1.5 x ULN, or reatinine clearance rate ≥60 mL/minute calculated.
Who cannot join
- Previous received or planned to be vaccinated with 2019-nCoV vaccine or other vaccines within 3 months prior to the start of study treatment or during the study or within 3 months after the end of the study;
- Previous radiotherapy within 4 weeks prior to the start of study treatment. (if palliative radiotherapy was given to bone metastatic side peripherally and the patient recovered from acute toxicity was allowed).
- Previous anti-tumor therapy within 4 weeks prior to the start of study treatment.
- Previous major operation within 8 weeks prior to the start of study treatment.
- Prior severe allergic reaction or intolerance to a monoclonal antibody, including humanised or chimeric antibodies.
- Symptomatic cerebral metastases.
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- Uncontrolled or severe illness.
- Known human immunodeficiency virus infection or known symptomatic hepatitis
- Other clinically significant disease which may have adversely affected the safe delivery of treatment within this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Lin Shen, PhD, 010-88196358, doctorshenlin@sina.cn
Lin Shen, PhD
About this study
Official title: A Phase I, Multi-center, Open-label, Single-dose Escalation and Expansion, Dose Escalation and Expansion Combination With Chemotherapy Study Evaluating the Safety, Tolerability and Pharmacokinetic Profile of M108 Monoclonal Antibody in Patients With Advanced Unresectable Solid Tumors in China
M108 is a monoclonal antibody specific for gastric and gastroesophageal adenocarcinomas. The aim of this phase I study is to establish safety and Tolerability of different Dosage regimen in patients With Advanced Unresectable Solid Tumors in China.
- Conditions
- Advanced Unresectable Solid Tumors
- Being tested
- M108
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M108Drug
Also called Chemotherapy
Monotherapy: Accelerated titration method, IV infusion Q3W; Conventional 3 + 3 study design, IV infusion Q3W. (21-day cycles) Combined with chemotherapy: Conventional 3 + 3 study design, IV infusion Q3W. (21-day cycles)
M108Drug
Also called Chemotherapy.
IV infusion Q3W. (21-day cycles)
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Cohort | Experimental | Monotherapy: Five dose levels of M108 will be tested according to an accelerated titration method followed by a conventional 3 + 3 study design.
Combined with chemotherapy: Three dose levels of M108 will be tested by a conventional 3 + 3 study design.
The dose-limiting toxicity (DLT) will be assessed from the first administration to the end of the first cycle (21 days). Receives: Drug: M108 |
| Dose Expansion Cohort | Experimental | Once the effective dose has been determined, 1~2 expansion cohorts will be opened to evaluate the efficacy and safety of the selected dose. Receives: Drug: M108 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)
Measured: From enrollment until 28+7 days after the last dose
Maximum Tolerated Dose
MTD
Measured: 21 days
Secondary outcomes (6)
Maximum measured plasma concentration of M108
Cmax
Measured: From enrollment until 28 days after the last dose
Time to maximum plasma concentration of M108
Tmax
Measured: From enrollment until 28 days after the last dose
Half-life of M108
T1/2
Measured: From enrollment until 28 days after the last dose
Immunogenicity profile of M108
Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies(ADA).
Measured: From enrollment until 28 days after the last dose
Objective Response Rate
ORR
Measured: From first dose to disease progression , death or end of study，an average of 1 year
Progression free survival
PFS
Measured: From first dose to disease progression , death or end of study，an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start11 Jun 2021
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Unresectable Solid TumorsStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FutureGen Biopharmaceutical (Beijing) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894825
- Sponsor's protocol ID
- M108-Ⅰ
- Status last verified
- Nov 2023
- First submitted
- 12 May 2021
- Last updated
- 27 Nov 2023
- 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 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multi-center, Open-label, Single-dose Escalation and Expansion, Dose Escalation and Expansion Combination With Chemotherapy Study Evaluating the Safety, Tolerability and Pharmacokinetic Profile of M108 Monoclonal Antibody in Patients With Advanced Unresectable Solid Tumors in China
- ClinicalTrials.gov ID
- NCT04894825
- Acronym / sponsor ID
- M108-Ⅰ
- Conditions
- Advanced Unresectable Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- FutureGen Biopharmaceutical (Beijing) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 20 May 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.
M108 is a monoclonal antibody specific for gastric and gastroesophageal adenocarcinomas. The aim of this phase I study is to establish safety and Tolerability of different Dosage regimen in patients With Advanced Unresectable Solid Tumors in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Cohort | Experimental | Drug: M108Monotherapy: Five dose levels of M108 will be tested according to an accelerated titration method followed by a conventional 3 + 3 study design. Combined with chemotherapy: Three dose levels of M108 will be tested by a conventional 3 + 3 study design. The dose-limiting toxicity (DLT) will be assessed from the first administration to the end of the first cycle (21 days). |
| Dose Expansion Cohort | Experimental | Drug: M108Once the effective dose has been determined, 1~2 expansion cohorts will be opened to evaluate the efficacy and safety of the selected dose. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Written informed consent.
- Advanced Unresectable solid tumors proven by histology
- At least 1 measurable site of the disease according RECIST 1.1 criteria
- ECOG performance status (PS) 0-1
- Life expectancy > 3 months
Key exclusion criteria (9 listed)
- Previous received or planned to be vaccinated with 2019-nCoV vaccine or other vaccines within 3 months prior to the start of study treatment or during the study or within 3 months after the end of the study;
- Previous radiotherapy within 4 weeks prior to the start of study treatment. (if palliative radiotherapy was given to bone metastatic side peripherally and the patient recovered from acute toxicity was allowed).
- Previous anti-tumor therapy within 4 weeks prior to the start of study treatment.
- Previous major operation within 8 weeks prior to the start of study treatment.
- Prior severe allergic reaction or intolerance to a monoclonal antibody, including humanised or chimeric antibodies.
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 |
|---|---|---|
| M108Also: ChemotherapyMonotherapy: Accelerated titration method, IV infusion Q3W; Conventional 3 + 3 study design, IV infusion Q3W. (21-day cycles) Combined with chemotherapy: Conventional 3 + 3 study design, IV infusion Q3W. (21-day cycles) | Drug | Dose Escalation Cohort |
| M108Also: Chemotherapy.IV infusion Q3W. (21-day cycles) | Drug | Dose Expansion Cohort |
Primary outcome
Incidence of adverse events
Time frame: From enrollment until 28+7 days after the last dose
defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)
Maximum Tolerated Dose
Time frame: 21 days
MTD
6 secondary outcomes
Maximum measured plasma concentration of M108
Time frame: From enrollment until 28 days after the last dose
Time to maximum plasma concentration of M108
Time frame: From enrollment until 28 days after the last dose
Half-life of M108
Time frame: From enrollment until 28 days after the last dose
Immunogenicity profile of M108
Time frame: From enrollment until 28 days after the last dose
Objective Response Rate
Time frame: From first dose to disease progression , death or end of study，an average of 1 year
Progression free survival
Time frame: From first dose to disease progression , death or end of study，an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
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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 M108 in people with Advanced Unresectable Solid Tumors, run by FutureGen Biopharmaceutical (Beijing) 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 9 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 27 Nov 2023. 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 Zhaoyu Jin, Ph.D (010-60709130, pr@futuregenbiopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: From enrollment until 28+7 days after the last dose). 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 27 Nov 2023.