A Phase I, First-in-Human Study of GB268 (PD-1/CTLA-4/VEGF Trispecific Antibody) in Advanced Solid Tumors

NCT06934616 | Not Yet Recruiting Phase 1

• 1 other identifier: GB268-001
• Study Type: interventional
• Target: 330
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Solid Tumor Cancer

Keywords

PD-1; CTLA-4; VEGF; anti-PD-1/CTLA-4/VEGF trispecific antibody; advanced solid tumors; Phase I

Outcome Measures

Primary Outcomes (2)

• 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)

  Up to approximately 2 years

• Dose Limiting Toxicity (DLT)

  Incidence of Dose Limiting Toxicity (DLT) during the first cycle of treatment

  21 days

Secondary Outcomes (8)

• ORR

  Up to approximately 2 years

• DOR

  Up to approximately 2 years

• DCR

  Up to approximately 2 years

• PFS

  Up to approximately 2 years

• Cmax of GB268

  Up to approximately 2 years

Study Arms (1)

GB268

EXPERIMENTAL

Drug: GB268

Interventions

GB268 DRUG

GB268 will be administered via intravenous infusion once every 3 weeks on Days 1 of each 21-day cycle

GB268

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.
• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Genor Biopharma Co., Ltd.: lead

MeSH Terms

Conditions

Diabetes Mellitus, Insulin-Dependent, 12

Central Study Contacts

Zhigang Yan, Bachelor

CONTACT

86-18310577427; zhigang.yan@genorbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2025
• First Posted: April 18, 2025
• Study Start: April 24, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share