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
Sponsor study identifier
interventional
152
1 country
1
Study Start
June 11, 2021
Actual (reported)Primary Completion
July 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 12, 2021
Actual (reported)May 20, 2021
Actual (reported)June 11, 2021
Actual (reported)July 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Incidence of adverse events
defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)
From enrollment until 28+7 days after the last dose
Maximum Tolerated Dose
MTD
21 days
Maximum measured plasma concentration of M108
From enrollment until 28 days after the last dose
Time to maximum plasma concentration of M108
From enrollment until 28 days after the last dose
Half-life of M108
From enrollment until 28 days after the last dose
Immunogenicity profile of M108
From enrollment until 28 days after the last dose
Objective Response Rate
From first dose to disease progression , death or end of study，an average of 1 year
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).
Once the effective dose has been determined, 1\~2 expansion cohorts will be opened to evaluate the efficacy and safety of the selected dose.
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)
IV infusion Q3W. (21-day cycles)
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
First Submitted
May 12, 2021
First Posted
May 20, 2021
Study Start
June 11, 2021
Actual (reported)Primary Completion
July 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Study Completion
December 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 27, 2023
Record last verified: 2023-11
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Source: ClinicalTrials.gov.
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