RecruitingNCT07929909ClinicalTrials.gov record

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

Glioma · Glioblastoma · Brain Neoplasms

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THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Phase 1
Age range: 18 years - 70 years
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 50 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 the full description

YN003 is an investigationalliposome injection designed to deliver the active drug preferentially to specific glioma tissue. Part A will evaluate ascending doses of YN003 administered by intravenous infusion once every 4 weeks to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). The dose-limiting toxicity (DLT) observation period is 28 days. Approximately 21 to 30 DLT-evaluable subjects will be enrolled in Part A. Part B will enroll approximately 10 to 20 additional subjects at the RP2D to further evaluate safety, pharmacokinetics, and preliminary efficacy. The study will be conducted in the United States and China.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Not applicable
Masking: No masking

Study Drug： YN003 Injection

Single-arm, open-label study of YN003 administered by intravenous infusion once every 4 weeks.

Drug: YN003 Injection

YN003 Injection DRUG

YN003 is an investigational liposome injection designed to deliver the drug preferentially to specific glioma tissue. Part A will evaluate ascending doses of YN003 administered by intravenous infusion once every 4 weeks to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). The dose-limiting toxicity (DLT) observation period is 28 days. Approximately 21 to 30 DLT-evaluable subjects will be enrolled in Part A. Part B will enroll approximately 10 to 20 additional subjects at the RP2D to further evaluate safety, pharmacokinetics, and preliminary efficacy. The study will be conducted in the United States and China.

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