A Phase I Clinical Study of YN003 in the Treatment of Glioma
NCT07929909, Phase 1, Recruiting, Beijing Inno Medicine Co., Ltd.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Phase I Clinical Study of YN003 in the Treatment of Glioma | ClinicalTrials.gov |
| NCT number | NCT07929909 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 1 | ClinicalTrials.gov |
| Enrollment | 50 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Beijing Inno Medicine Co., Ltd. | ClinicalTrials.gov |
| Conditions | Glioma, Glioblastoma, Brain Neoplasms | ClinicalTrials.gov |
| Interventions | YN003 Injection | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | To Incidence and characteristics of AEs/SAEs； | From first dose of YN003 to 30 days after the last dose (or initiation of new antitumor therapy, whichever occurs first) | Assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 6.0. | ClinicalTrials.gov |
| Primary | Incidence of clinically significant abnormalities in laboratory tests | From first dose of YN003 to 30 days after the last dose (or initiation of new antitumor therapy, whichever occurs first) | Percentage of participants with clinically significant abnormalities in hematology, blood chemistry, urinalysis, and coagulation lipid, Thyroid function. | ClinicalTrials.gov |
| Primary | Incidence of clinically significant abnormalities in vital signs | From first dose of YN003 to 30 days after the last dose (or initiation of new antitumor therapy, whichever occurs first) | Percentage of participants with clinically significant abnormalities in body temperature, respiratory rate, blood pressure, pulse rate, and oxygen saturation. | ClinicalTrials.gov |
| Primary | Incidence of clinically significant abnormalities in physical examinations | From first dose of YN003 to 30 days after the last dose (or initiation of new antitumor therapy, whichever occurs first) | Percentage of participants with clinically significant abnormalities in general physical examinations and neurological examinations. | ClinicalTrials.gov |
| Primary | Change from baseline in 12-lead Electrocardiogram (ECG) parameters | From first dose of YN003 to 30 days after the last dose (or initiation of new antitumor therapy, whichever occurs first) | To Incidence and characteristics of Clinically significant changes of ECG The ECG evaluation must include heart rate, QT interval, QTcF, and PR interval. | ClinicalTrials.gov |
| Primary | To assess the tolerability of YN003 in subjects with recurrent/progressive glioma (WHO grade 3 - 4) | First 28 days after the first dose of YN003 MTD：During dose escalation (Part A), approximately 21-30 DLT-evaluable subjects] | Dose-limiting toxicity (DLT) Maximum tolerated dose (MTD) | ClinicalTrials.gov |
| Secondary | Peak Plasma Concentration (Cmax) and Time to Peak Plasma Concentration (Tmax) of YN003 | Up to 28 days of post initiation of last dose | Maximum observed plasma concentration (Cmax) and time to reach maximum observed plasma concentration (Tmax). | ClinicalTrials.gov |
| Secondary | Area Under the Plasma Concentration-Time Curve (AUC) of YN003 | Up to 28 days of post initiation of last dose | Area under the plasma concentration versus time curve from time zero to the last quantifiable time point (AUC0-t) and from time zero to infinity (AUC0-∞). | ClinicalTrials.gov |
| Secondary | Terminal Half-life (t1/2), Clearance (CL), and Volume of Distribution (Vd) of YN003 | Up to 28 days of post initiation of last dose | Terminal elimination half-life, total body clearance, and apparent volume of distribution. | ClinicalTrials.gov |
| Secondary | Overall Survival (OS) | From 1st dose to death from any cause, assessed at 6 and 12 months after first dose. | OS rates at 6 and 12 months. | ClinicalTrials.gov |
| Secondary | Progression-Free Survival (PFS) | From 1st dose until the date to first documented disease progression or death from any cause, whichever comes first, assessed at 6 and 12 months after first dose. | PFS rates at 6 and 12 months, assessed by the investigator per RANO 2.0 criteria. | ClinicalTrials.gov |
| Secondary | Objective Response Rate (ORR) | From first dose until disease progression or initiation of new antitumor therapy (estimated up to 2 years). | Percentage of participants with a confirmed complete response (CR) or partial response (PR) as assessed by the investigator per RANO 2.0 criteria. | ClinicalTrials.gov |
| Secondary | Duration of Response (DoR) | From the date of 1st dose to the date of first documented disease progression or death (estimated up to 1 year). | Time from the first documented objective response to the date of first documented disease progression or death from any cause, whichever comes first. | ClinicalTrials.gov |
| Secondary | Disease Control Rate (DCR) | From first dose until disease progression or initiation of new antitumor therapy (estimated up to 2 years). | Percentage of participants with a confirmed complete response (CR), partial response (PR), or stable disease (SD) as assessed by the investigator per RANO 2.0 criteria. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)