YN003 injection in glioma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, single-arm, dose-escalation and dose-expansion phase 1 trial of YN003 Injection for adults with recurrent or progressive glioma, including glioblastoma. Part A uses a Bayesian design to find the maximum tolerated dose and the recommended phase 2 dose with a 28-day evaluation period for dose-limiting toxicities. Part B expands at the RP2D to further assess safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy. YN003 is a liposome-based formulation intended to deliver the active drug more directly to glioma tissue. The study will enroll patients in the United States and China across multiple sites.

Why it matters

Who can join: the full rules

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

Where it's running

• Beijing Tsinghua Changgung Hospital
  Beijing, Beijing Municipality, China Recruiting
• Sanbo Brain Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• University of California, Los Angeles (UCLA)
  Los Angeles, California, United States Not yet recruiting
• University of California, San Francisco (UCSF)
  San Francisco, California, United States Not yet recruiting
• The University of Texas MD Anderson Cancer Center
  Houston, Texas, United States Not yet recruiting

Study contacts

• Study coordinator: Kaiqi Zong, Master
• Email: zongkaiqi@innovmedicine.com
• Phone: 13683178623

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.