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New treatment option for Recurrent Glioma
Official title A Study of GNC-039, a Tetra-specific Antibody, in Participants With Relapsed/Refractory or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT04794972
What this study is testing
What is GNC-039?
GNC-039 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for recurrent glioma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- In this study, the safety, tolerability and preliminary effectiveness of GNC-039 in patients with relapsed/refractory or metastatic glioma or other solid tumors will be investigated to assess the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) or maximum administered dose (MAD) for MTD is not reached of GNC-039.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- After failure of standard treatment (surgery, stupp regimen), people with diagnosed recurrent high-grade glioma (WHO Grade III-IV), or other...
- No gender limitation.
- Age: ≥18 years old.
- KPS≥60 points.
- The expected survival as determined by the researchers was ≥3 months.
You likely can't join if
- Patients who are allergic to immunoglobulin or any component of the injectable formulation of GNC-039.
- Patients with active infections requiring intravenous antibiotics who did not complete treatment 1 week prior to enrollment, except those who...
- Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active hepatitis B virus infection (HBsAg positive or HBcAb positive...
- Toxicity from prior antitumor therapy did not decrease to ≤ grade 1 as defined in CTCAE version 5.0 (except for toxicities that the investigators...
- Patients at risk for active autoimmune diseases, or with a history of autoimmune diseases that may involve the central nervous system, Including but...
- Lung disease defined by NCI-CTCAE v5.0 as ≥ grade 3, including patients with resting dyspnea, or in need of continuous oxygen therapy, or with a...
See the full eligibility criteria
- After failure of standard treatment (surgery, stupp regimen), people with diagnosed recurrent high-grade glioma (WHO Grade III-IV), or other recurrent/refractory or metastatic solid tumors can understand the informed...
- No gender limitation.
- Age: ≥18 years old.
- KPS≥60 points.
- The expected survival as determined by the researchers was ≥3 months.
- Hematological functions meet the following requirements: neutrophil absolute count (ANC) ≥1.5×109/L, platelet count ≥75×109/L, hemoglobin ≥90g/L.
- Renal function meets the following requirements: creatinine (Cr) ≤1.5 ULN and creatinine clearance (Ccr) ≥50 mL/min (based on the calculation criteria of the study center), urinary protein ≤2+ or \< 1000mg/24h (urine).
- Liver functions meet the following requirements: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN; Total bilirubin ≤1.5×ULN (Gilbert's syndrome ≤3×ULN).
- Coagulation function: fibrinogen ≥1.5g/L; Activated partial thromboplastin time (APTT) ≤1.5×ULN; Prothrombin time (PT) ≤1.5×ULN.
- A fertile female subject or a fertile male subject with a fertile partner must use highly effective contraception from the date of informed consent until 12 weeks after the last dosing. Serum pregnancy tests must be...
- Subject is able and willing to comply with visits, treatment plans, laboratory tests, and other study-related procedures as specified in the study protocol.
- For glioma patients: a. There must be a pathological diagnosis and a definite diagnosis of high-grade glioma; b. MRI diagnosis supported recurrence; c. Presence of at least one measurable tumor lesion according to RANO...
- For patients with other solid tumors: a. Histologically or cytologically confirmed recurrent/refractory or metastatic solid tumors with disease progression confirmed by imaging or other objective evidence after standard...
- Patients who are allergic to immunoglobulin or any component of the injectable formulation of GNC-039.
- Patients with active infections requiring intravenous antibiotics who did not complete treatment 1 week prior to enrollment, except those who received prophylactic antibiotics for puncture or biopsy.
- Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active hepatitis B virus infection (HBsAg positive or HBcAb positive with HBV-DNA copy number ≥ULN) or hepatitis C virus infection...
- Toxicity from prior antitumor therapy did not decrease to ≤ grade 1 as defined in CTCAE version 5.0 (except for toxicities that the investigators judged to be of no safety risk, such as alopecia, grade 2 peripheral...
- Patients at risk for active autoimmune diseases, or with a history of autoimmune diseases that may involve the central nervous system, Including but not limited to Crohn's disease, ulcerative colitis, systemic lupus...
- Lung disease defined by NCI-CTCAE v5.0 as ≥ grade 3, including patients with resting dyspnea, or in need of continuous oxygen therapy, or with a history of interstitial lung disease (ILD).
- Previous organ transplant recipients.
- History of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, degree III...
- Thrombotic events such as deep vein thrombosis, arterial thrombosis, and pulmonary embolism occurred within 6 months prior to screening.
- Other conditions deemed unsuitable for participation in this clinical trial by the investigator.
- Brain gliomas: a. Patients who underwent surgery, chemotherapy, targeted and immunotherapy, iodine in vivo radiation, radiation therapy, or planned to undergo radiation therapy during the trial within 4 weeks of...
- For other solid tumors: a. Received chemotherapy, antibody therapy, molecular-targeted therapy, or investigational drugs within 4 weeks or 5 half-lives (whichever is shorter) of initial administration; b. Patients who...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Guangzhou, Guangdong, China
- Shenzhen, Guangdong, China
- Xian, Shanxi, China
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Guangzhou, Guangdong, China; Shenzhen, Guangdong, China; Xian, Shanxi, China; Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.