Solid Tumor CancerPhase 1NCT06934616
A Phase I, First-in-Human Study of GB268 (PD-1/CTLA-4/VEGF Trispecific Antibody) in Advanced Solid Tumors
A Phase 1 study testing GB268 in people with Solid Tumor Cancer, run by Genor Biopharma Co., Ltd..
Trial summary
This is a Phase I, First-in-Human, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of a Trispecific PD-1/CTLA-4/VEGF Antibody GB268 in Participants with Advanced Solid Tumors. The study will consist of a dose-escalation stage and an dose-expansion stage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Cancer
- What is being tested?
- GB268
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- No sites listed yet
- Study dates
- 24 Apr 2025to Mar 2028
- 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
- ≥ 18 years of age at the time of Informed Consent.
- Able to give voluntary informed consent and are willing to follow and complete all the study required procedures.
- Participants with histologically or cytologically confirmed locally advanced, metastatic or unresectable solid tumors that have failed standard therapy, or for whom no standard therapy exists, or where standard therapy is contraindicated.
- Participants must have measurable disease according to Response Criteria in Solid Tumors (RECIST) v1.1.
- ECOG performance status ≤ 1.
- Participants with HCC must have a Child-Pugh score class A.
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- Life expectancy ≥ 3 months.
- Participants must have adequate organ function
- Tumor tissue samples for biomarker testing are highly desirable (mandatory in dose expansion part)
- For women of childbearing potential: participants must have a negative serum pregnancy test within 7 days prior to Cycle 1 Day 1 and agree to abstain from heterosexual intercourse or use an acceptable contraceptive method during the study and for at least 6 months following the final administration of GB268.
- For male participants: agreement to abstain from heterosexual intercourse or use of an acceptable contraceptive method during the study treatment and for at least 6 months following the final infusion, and agreement to refrain from sperm donation during the study treatment and for at least 6 months following the final administration of GB268.
Who cannot join
- Received the following treatments or medications before starting the study treatment:
- Participants who received the last systemic anti-tumor therapy, including chemotherapy, biological agents etc., within 3 weeks prior to Cycle 1 Day 1; participants who received hormonal anti-tumor therapy and small molecule targeted therapy within 2 weeks prior to Cycle 1 Day 1; and participants who received Chinese herbal medicine or traditional Chinese medicinal products with anti-tumor indications within 2 weeks prior to Cycle 1 Day 1. Participants who received non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, tumor necrosis factor, etc.) within 2 weeks prior to Cycle 1 Day 1.
- Received a live or attenuated vaccination within 4 weeks prior to Cycle 1 Day 1.
- Prior radiation therapy completed within 3 weeks prior to Cycle 1 Day 1. Palliative radiotherapy for the control of symptoms is allowed to be completed at least 2 weeks prior to Cycle 1 Day 1.
- Treatment with systemic immunosuppressive medications within 2 weeks prior to Cycle 1 Day 1.
- Participants who have, or will have, any of the following:
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- An invasive operative procedure within 4 weeks of, or with incomplete recovery, before Cycle 1 Day 1. Participants who have undergone minor local procedure (excluding peripherally inserted central catheterisation and intravenous infusion port implantation) within 3 days prior to Cycle 1 Day 1.
- Significant traumatic injury within 4 weeks prior to Cycle 1 Day 1 (all wounds must be fully healed prior to Cycle 1 Day 1).
- Any medical condition that affects wound healing capacity and is expected to endanger participant safety if wound healing capacity would be severely reduced during administration of the investigational product.
- Major surgery expected during study participation.
- Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to Grade ≤ 1
- Participants who have experienced ≥ Grade 3 immune-related adverse events (irAE) or irAE leading to treatment discontinuation
- Has known active central nervous system (CNS) metastases.
- Participants with a history of other malignancies unless the patient has undergone potentially curative therapy with no evidence of that disease for 3 years prior to Cycle 1 Day 1
- Uncontrolled pleural effusion, or ascites requiring recurrent drainage procedures within 4 weeks prior to Cycle 1 Day 1.
- History of clinically significant cardiovascular disease.
- History of interstitial lung disease (ILD).
- Active or prior documented autoimmune disease required systemic treatment within the past 2 years.
- Active or prior history of inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea).
- Prior history of hypertensive crisis or hypertensive encephalopathy.
- Participants with significant coagulation disorders or other obvious evidence of bleeding risk.
- History of abdominal fistula, tracheoesophageal fistula, and female genital fistula (e.g., vesicovaginal fistula, urethrovaginal fistula, and vesicocervical fistula, etc.), gastrointestinal perforation, or abdominal abscess, or patient has risk factors for gastrointestinal obstruction at the discretion of the investigator.
- Active infection that have received systemic anti-infective treatment within 2 weeks prior to Cycle 1 Day 1. Serious infections within 4 weeks prior to Cycle 1 Day 1, including but not limited to complications requiring hospitalization, sepsis or severe pneumonia.
- Participants with uncontrolled concurrent illness, including, but not limited to, poorly controlled hypertension or Type 2 diabetes mellitus, or psychiatric illness or a social situation that would limit compliance with the study requirements.
- Known presence of active tuberculosis.
- Participants have at screening:
- Positive hepatitis B (hepatitis B virus [HBV]) surface antigen (HBsAg) or Hepatitis B Core Antibody (HBcAb), with HBV-DNA result greater than 500 IU/mL (or 2500 copies/mL).
- Positive hepatitis C virus antibody (anti-HCV), with HCV-RNA result greater than the lower limit of quantification.
- History of primary immunodeficiency. Participants who have previously been positive for human immunodeficiency virus (HIV) antibody, or are positive for HIV at screening.
- History of solid organ or blood system transplantation, except for corneal transplantation.
- Female patients who are pregnant, or breast-feeding.
- Patients with known allergies, hypersensitivity, or intolerance to GB268 or its excipients. Patients with history of severe hypersensitivity reactions to other mAbs.
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase I, First-in-Human, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of a Trispecific PD-1/CTLA-4/ VEGF Antibody GB268 in Participants With Advanced Solid Tumors
This is a Phase I, First-in-Human, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of a Trispecific PD-1/CTLA-4/VEGF Antibody GB268 in Participants with Advanced Solid Tumors. The study will consist of a dose-escalation stage and an dose-expansion stage.
- Conditions
- Solid Tumor Cancer
- Being tested
- GB268
- Keywords
- PD-1, CTLA-4, VEGF, anti-PD-1/CTLA-4/VEGF trispecific antibody, advanced solid tumors, Phase I
- Medical subject headings
- Diabetes Mellitus, Insulin-Dependent, 12
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB268Drug
GB268 will be administered via intravenous infusion once every 3 weeks on Days 1 of each 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| GB268 | Experimental | Not described Receives: Drug: GB268 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
Safety as assessed by clinical laboratory tests, 12-lead electrocardiogram (ECG), vital signs measurements, and the incidence, nature and severity of all adverse events (AEs) and serious AEs (SAEs)
Measured: Up to approximately 2 years
Dose Limiting Toxicity (DLT)
Incidence of Dose Limiting Toxicity (DLT) during the first cycle of treatment
Measured: 21 days
Secondary outcomes (8)
ORR
objective response rate assessed by investigator per RECIST v1.1
Measured: Up to approximately 2 years
DOR
duration of response assessed by investigator per RECIST v1.1
Measured: Up to approximately 2 years
DCR
disease control Rate assessed by investigator per RECIST v1.1
Measured: Up to approximately 2 years
PFS
progression free survival assessed by investigator per RECIST v1.1
Measured: Up to approximately 2 years
Cmax of GB268
Peak plasma concentration
Measured: Up to approximately 2 years
Tmax of GB268
Time to peak drug concentration
Measured: Up to approximately 2 years
AUC of GB268
Area under curve
Measured: Up to approximately 2 years
ADA of GB268
Detection of anti-GB268 antibodies
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start24 Apr 2025 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor CancerStudies of the same condition, open and under way.
- 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
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genor Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934616
- Sponsor's protocol ID
- GB268-001
- Status last verified
- Apr 2025
- First submitted
- 16 Mar 2025
- Last updated
- 30 Apr 2025
- Results posted
- 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 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, First-in-Human, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of a Trispecific PD-1/CTLA-4/ VEGF Antibody GB268 in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06934616
- Acronym / sponsor ID
- GB268-001
- Conditions
- Solid Tumor Cancer
- Keywords
- PD-1, CTLA-4, VEGF, anti-PD-1/CTLA-4/VEGF trispecific antibody, advanced solid tumors, Phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Genor Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Apr 2025 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 18 Apr 2025 (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.
This is a Phase I, First-in-Human, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of a Trispecific PD-1/CTLA-4/VEGF Antibody GB268 in Participants with Advanced Solid Tumors. The study will consist of a dose-escalation stage and an dose-expansion stage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GB268 | Experimental | Drug: GB268 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ≥ 18 years of age at the time of Informed Consent.
- Able to give voluntary informed consent and are willing to follow and complete all the study required procedures.
- Participants with histologically or cytologically confirmed locally advanced, metastatic or unresectable solid tumors that have failed standard therapy, or for whom no standard therapy exists, or where standard therapy is contraindicated.
- Participants must have measurable disease according to Response Criteria in Solid Tumors (RECIST) v1.1.
- ECOG performance status ≤ 1.
Key exclusion criteria (33 listed)
- Received the following treatments or medications before starting the study treatment:
- Treatment with systemic immunosuppressive medications within 2 weeks prior to Cycle 1 Day 1.
- Participants who have, or will have, any of the following:
- Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to Grade ≤ 1
- Participants who have experienced ≥ Grade 3 immune-related adverse events (irAE) or irAE leading to treatment discontinuation
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 |
|---|---|---|
| GB268GB268 will be administered via intravenous infusion once every 3 weeks on Days 1 of each 21-day cycle | Drug | GB268 |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: Up to approximately 2 years
Safety as assessed by clinical laboratory tests, 12-lead electrocardiogram (ECG), vital signs measurements, and the incidence, nature and severity of all adverse events (AEs) and serious AEs (SAEs)
Dose Limiting Toxicity (DLT)
Time frame: 21 days
Incidence of Dose Limiting Toxicity (DLT) during the first cycle of treatment
8 secondary outcomes
ORR
Time frame: Up to approximately 2 years
DOR
Time frame: Up to approximately 2 years
DCR
Time frame: Up to approximately 2 years
PFS
Time frame: Up to approximately 2 years
Cmax of GB268
Time frame: Up to approximately 2 years
Tmax of GB268
Time frame: Up to approximately 2 years
AUC of GB268
Time frame: Up to approximately 2 years
ADA of GB268
Time frame: Up to approximately 2 years
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 30 Apr 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GB268 in people with Solid Tumor Cancer, run by Genor Biopharma Co., Ltd..
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 11 inclusion and 33 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: opening soon, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Zhigang Yan, Bachelor (86-18310577427, zhigang.yan@genorbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AEs) (time frame: Up to approximately 2 years). The study lists 2 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 30 Apr 2025.