Recurrent GliomaPhase 1NCT04794972
A Study of GNC-039, a Tetra-specific Antibody, in Participants With Relapsed/Refractory or Metastatic Solid Tumors
A Phase 1 study testing GNC-039 in people with Recurrent Glioma and Solid Tumor, run by Sichuan Baili Pharmaceutical Co., Ltd. at 6 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Glioma, Solid Tumor
- What is being tested?
- GNC-039
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 6 sitesChina
- Study dates
- 14 Apr 2021to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- After failure of standard treatment (surgery, stupp regimen), subjects with diagnosed recurrent high-grade glioma (WHO Grade III-IV), or other recurrent/refractory or metastatic solid tumors can understand the informed consent, voluntarily participate in and sign the informed consent.
- 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.
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- 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 negative for fertile female subjects within -10 to -3 days prior to initial dosing.
- 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 criteria; Or subjects receiving surgical treatment after recurrence; d. Archived primary or recurrent tumor tissue or sections that can be submitted to the Center for review (no less than 10 pathological white slices of 3-5μm or corresponding tissue blocks should be provided). If patients are unable to provide tumor tissue specimens, the Center may inform the sponsor and enroll them.
- 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 treatment; Or subjects with refractory solid tumors who cannot tolerate standard therapy or have contraindications to standard therapy; b. Must have at least one measurable lesion that meets the RECIST v1.1 definition.
Who cannot join
- 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 (HCV-RNA≥ULN).
- 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 neurotoxicity, stable hypothyroidism after hormone replacement therapy, etc.).
- 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 erythematosus, Wegener syndrome, autoimmune hepatitis, systemic sclerosis, Hashimoto's thyroiditis, autoimmune vasculitis, autoimmune neuropathy (Guillain-Barre syndrome), etc. Exceptions include type I diabetes mellitus, hypothyroidism stable on hormone replacement therapy (including hypothyroidism caused by autoimmune thyroid disease), psoriasis or vitiligo that do not require systemic therapy, and autoimmune diseases caused by B cells and anti-autoimmune antibodies.
- 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).
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- 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 atrioventricular block, etc.; At rest, the QT interval was prolonged (QTc > 450 msec in men or 470 msec in women); Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events occurred within 6 months prior to initial administration; There is heart failure ≥II on the New York Heart Association (NYHA) cardiac function scale.
- 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 enrollment or 5 half-lives, whichever is shorter; b. Patients who had received intracranial lesion puncture biopsy within 7 days prior to enrollment; c. Received other investigational drugs or treatments that are not on the market within 4 weeks prior to enrollment; d. There was a history of central nervous system bleeding/infarction not associated with antineoplastic agents, such as stroke or intracranial and ocular bleeding (including embolic stroke), during the 6 months prior to enrollment.
- 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 underwent major surgery within 28 days prior to administration of the drug or were scheduled to undergo major surgery during the study period (except for procedures such as puncture or lymph node biopsy); c. poorly controlled hypertension (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg); d. Previous or associated central nervous system lesions, including but not limited to: paralysis, stroke (except those with lacunar infarction indicated by imaging examination but without treatment), severe brain injury, senile dementia, Parkinson's disease, organic brain syndrome, and psychosis; e. Received other investigational drugs or treatments that were not on the market within 4 weeks prior to enrollment.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Wenbin Li
Zhuang Kang
- Recruiting
West China Hospital，Sichuan University
Chengdu, Sichuan
Yongsheng Wang
- Recruiting
Affiliated Cancer Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Haifeng Yang
Yongsheng Li
- Recruiting
ZhuJiang Hospital of Southern Medical University
Guangzhou, Guangdong
Hongbo Guo
- Recruiting
Shenzhen Second People's Hospital
Shenzhen, Guangdong
Weiping Li
- Recruiting
The First Affiliated Hospital of Xi'an Jiao Tong University
Xian, Shanxi
Maode Wang
About this study
Official title: An Open-Label, Multi-Center, Phase I Study to Evaluate the Safety, Tolerability，Pharmacokinetic/Pharmacodynamics and Anti-tumor Activity of Tetra-specific Antibody GNC-039 in Participants With Relapsed/Refractory or Metastatic Solid Tumors
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.
- Conditions
- Recurrent Glioma, Solid Tumor
- Being tested
- GNC-039
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GNC-039Drug
Administration by intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Study treatment | Experimental | After the completion of the first cycle of treatment, if the patient has no intolerable toxic side effects during the first cycle of treatment, the investigator can communicate with the patient whether to continue the treatment during the 2-8 cycle. Receives: Drug: GNC-039 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
DLTs are assessed according to NCI-CTCAE v5.0 during the first cycle and defined as occurrence of any of the toxicities in DLT definition if judged by the investigator to be possibly, probably or definitely related to study drug administration.
Measured: Up to 14 days after the first dose of GNC-039
Maximum tolerated dose (MTD) or maximum administrated dose (MAD)
In the dose increment stage, the highest dose whose estimated DLT rate is closest to the target DLT rate but does not exceed the upper bound of the equivalent interval of DLT rate is selected as MTD.
Measured: Up to 14 days after the first dose of GNC-039
Treatment-Emergent Adverse Event (TEAE)
The incidence and severity of adverse events (TEAE) during treatment were graded according to the National Cancer Institute Standard for Common Terminology for Adverse Events (NCI-CTCAE, v5.0).
Measured: Up to approximately 24 months
Secondary outcomes (12)
Drug-related Adverse Events
Adverse Event (AE) refers to all adverse medical events that occur after a subject receives the investigational drug. Ae may be manifested as symptoms, signs, disease, or abnormalities in laboratory tests, but may not necessarily have a causal relationship with the investigational drug.
Measured: Up to approximately 24 months
Cmax: Maximum serum concentration of GNC-039
Maximum serum concentration (Cmax) of GNC-039 will be investigated.
Measured: Up to 14 days after the first dose of GNC-039
Tmax: Time to maximum serum concentration (Tmax) of GNC-039
Time to maximum serum concentration (Tmax) of GNC-039 will be investigated.
Measured: Up to 14 days after the first dose of GNC-039
T1/2: Half-life of GNC-039
Half-life (T1/2) of GNC-039 will be investigated.
Measured: Up to 14 days after the first dose of GNC-039
AUC0-inf: Area under the serum concentration-time curve from time 0 to infinity
Blood concentration - Area under time line.
Measured: Up to 14 days after the first dose of GNC-039
AUC0-t: Area under the serum concentration-time curve from time 0 to the time of the last measurable concentration
Blood concentration - Area under time line.
Measured: Up to 14 days after the first dose of GNC-039
CL: Clearance in the serum of GNC-039 per unit of time
To study the serum clearance rate of GNC-039 per unit time.
Measured: Up to 14 days after the first dose of GNC-039
Incidence and titer of ADA (Anti-drug antibody)
Frequency and titer of anti-GNC-039 antibody (ADA) will be evaluated.
Measured: Up to approximately 24 months
ORR (Objective Response Rate )
ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.
Measured: Up to approximately 24 months
OS (Overall Survival)
Overall survival is the time from randomization to death from any cause.
Measured: Up to approximately 24 months
PFS (Progression-free Survival)
The PFS is defined as the time from the participant's first dose of GNC-039 to the first date of either disease progression or death, whichever occurs first.
Measured: Up to approximately 24 months
DOR (Duration of Response)
The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start14 Apr 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent GliomaStudies of the same condition, open and under way.
- More trials run by Sichuan Baili Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SystImmune Inc.
- Responsible party
- Sponsor
- Investigators
- Wenbin Li, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794972
- Sponsor's protocol ID
- GNC-039-101
- Status last verified
- Aug 2026
- First submitted
- 9 Mar 2021
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center, Phase I Study to Evaluate the Safety, Tolerability，Pharmacokinetic/Pharmacodynamics and Anti-tumor Activity of Tetra-specific Antibody GNC-039 in Participants With Relapsed/Refractory or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT04794972
- Acronym / sponsor ID
- GNC-039-101
- Conditions
- Recurrent Glioma, Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- SystImmune Inc.
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study treatment | Experimental | Drug: GNC-039After the completion of the first cycle of treatment, if the patient has no intolerable toxic side effects during the first cycle of treatment, the investigator can communicate with the patient whether to continue the treatment during the 2-8 cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- After failure of standard treatment (surgery, stupp regimen), subjects with diagnosed recurrent high-grade glioma (WHO Grade III-IV), or other recurrent/refractory or metastatic solid tumors can understand the informed consent, voluntarily participate in and sign the informed consent.
- No gender limitation.
- Age: ≥18 years old.
- KPS≥60 points.
- The expected survival as determined by the researchers was ≥3 months.
Key exclusion criteria (12 listed)
- 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 (HCV-RNA≥ULN).
- 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 neurotoxicity, stable hypothyroidism after hormone replacement therapy, etc.).
- 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 erythematosus, Wegener syndrome, autoimmune hepatitis, systemic sclerosis, Hashimoto's thyroiditis, autoimmune vasculitis, autoimmune neuropathy (Guillain-Barre syndrome), etc. Exceptions include type I diabetes mellitus, hypothyroidism stable on hormone replacement therapy (including hypothyroidism caused by autoimmune thyroid disease), psoriasis or vitiligo that do not require systemic therapy, and autoimmune diseases caused by B cells and anti-autoimmune antibodies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GNC-039Administration by intravenous infusion. | Drug | Study treatment |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: Up to 14 days after the first dose of GNC-039
DLTs are assessed according to NCI-CTCAE v5.0 during the first cycle and defined as occurrence of any of the toxicities in DLT definition if judged by the investigator to be possibly, probably or definitely related to study drug administration.
Maximum tolerated dose (MTD) or maximum administrated dose (MAD)
Time frame: Up to 14 days after the first dose of GNC-039
In the dose increment stage, the highest dose whose estimated DLT rate is closest to the target DLT rate but does not exceed the upper bound of the equivalent interval of DLT rate is selected as MTD.
Treatment-Emergent Adverse Event (TEAE)
Time frame: Up to approximately 24 months
The incidence and severity of adverse events (TEAE) during treatment were graded according to the National Cancer Institute Standard for Common Terminology for Adverse Events (NCI-CTCAE, v5.0).
12 secondary outcomes
Drug-related Adverse Events
Time frame: Up to approximately 24 months
Cmax: Maximum serum concentration of GNC-039
Time frame: Up to 14 days after the first dose of GNC-039
Tmax: Time to maximum serum concentration (Tmax) of GNC-039
Time frame: Up to 14 days after the first dose of GNC-039
T1/2: Half-life of GNC-039
Time frame: Up to 14 days after the first dose of GNC-039
AUC0-inf: Area under the serum concentration-time curve from time 0 to infinity
Time frame: Up to 14 days after the first dose of GNC-039
AUC0-t: Area under the serum concentration-time curve from time 0 to the time of the last measurable concentration
Time frame: Up to 14 days after the first dose of GNC-039
CL: Clearance in the serum of GNC-039 per unit of time
Time frame: Up to 14 days after the first dose of GNC-039
Incidence and titer of ADA (Anti-drug antibody)
Time frame: Up to approximately 24 months
ORR (Objective Response Rate )
Time frame: Up to approximately 24 months
OS (Overall Survival)
Time frame: Up to approximately 24 months
PFS (Progression-free Survival)
Time frame: Up to approximately 24 months
DOR (Duration of Response)
Time frame: Up to approximately 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wenbin Li principal investigator
Beijing Tiantan Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GNC-039 in people with Recurrent Glioma and Solid Tumor, run by Sichuan Baili Pharmaceutical Co., Ltd. at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sa Xiao, PHD (+86-15013238943, xiaosa@baili-pharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) (time frame: Up to 14 days after the first dose of GNC-039). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.