A Phase I Clinical Study of YN003 in the Treatment of Glioma
Key facts
- Where
- Beijing, ChinaSee the 2 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07929909, who can take part
Where in China
- Beijing Tsinghua Changgung HospitalBeijing, ChinaTaking people
- Sanbo Brain Hospital, Capital Medical UniversityBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Beijing Inno Medicine Co., Ltd.
- Trial code
- NCT07929909
- Record updated
- 10 November 2026
- Original description
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).Read full original descriptionShow less
A Phase 1, Open-Label, Single-Arm, Dose-Escalation and Dose-Expansion Study of YN003 Injection in Patients With Glioma
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).
Inclusion: 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: 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; 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; Pregnant or breastfeeding women.