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A Phase I Clinical Study of YN003 in the Treatment of Glioma

RecruitingPhase 1

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

Sponsor: Beijing Inno Medicine Co., Ltd. · Participants: 50 · Started: Oct 27, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07929909

Locations in the U.S.

CaliforniaUniversity of California, Los Angeles (UCLA), Los Angeles (Not yet recruiting)
University of California, San Francisco (UCSF), San Francisco (Not yet recruiting)
TexasThe 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.