A Phase I Clinical Study of YN003 in the Treatment of Glioma
A Phase 1, Open-Label, Single-Arm, Dose-Escalation and Dose-Expansion Study of YN003 Injection in Patients With Glioma
Who can join
Ages 18 to 70 · All sexes
Full eligibility criteria
Inclusion Criteria: * Voluntarily sign the informed consent form, understand the study, and be willing to comply with the protocol and complete all study procedures. * Male or female subjects 18 years ≤ aged ≤ 70 years. * Histologically confirmed recurrent or progressive glioma, including glioblastoma, as defined by the 2021 WHO Classification of Tumors of the Central Nervous System, Grade 3 to Grade 4, following standard therapy.Excluding re-irradiation for same lesions * Karnofsky Performance Status (KPS) ≥60. * At least one measurable lesion per RANO 2.0 criteria. * Have adequate hematologic, cardiac, hepatic, renal, coagulation, and pulmonary function at final screening. * Have completed the required washout period for prior therapies before dosing on Day 1. * Corticosteroid dose must be stable or tapering within 7 days prior to dosing. Exclusion Criteria: * Participation in another interventional clinical study within 1 month prior to the date when subject signed the consent form. * Receipt of a live vaccine within 30 days prior to study treatment. * Pregnant or breastfeeding women. * Clinically significant intracranial hypertension (e.g., impending brain herniation or requiring urgent palliative intervention) or uncontrolled seizures. Subjects requiring antiepileptic drugs are eligible only if the dose has been stable for ≥ 14 days prior to first dosing * Toxicities from prior anticancer therapy that have not recovered to CTCAE v6.0 Grade ≤1, except for alopecia or other events considered tolerable by the investigator. * Contraindications to MRI, including but not limited to pacemakers, epicardial pacing leads, infusion pumps, aneurysm clips, metal fragments, metallic prostheses, magnetic implants, intraocular metal objects, or non-removable metallic dental implants. * Uncontrolled or severe cardiovascular or cerebrovascular disease
About the study
This is a Phase 1, open-label, single-arm, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of YN003 Injection in patients with recurrent or progressive glioma. The study consists of Part A (dose escalation using a Bayesian Optimal Interval design) and Part B (dose expansion at the recommended Phase 2 dose).
What is being tested
- YN003 Injection (drug)
Sponsor: Beijing Inno Medicine Co., Ltd. · Participants: 50 · Started: Oct 27, 2026
Contact the study team
- Kaiqi Zong, Master · Phone: 13683178623
- Yaqian Cui, Master · Phone: 18811320289
Official record on ClinicalTrials.gov — NCT07929909
Locations in the U.S.
| California | University of California, Los Angeles (UCLA), Los Angeles (Not yet recruiting) University of California, San Francisco (UCSF), San Francisco (Not yet recruiting) |
| Texas | The University of Texas MD Anderson Cancer Center, Houston (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.