A Multicenter, Open-label, Phase II Clinical Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics (PK), and Immunogenicity of the Combination Therapy of SYS6026 in the Treatment of Advanced Solid Tumors

NCT07684261 | Not Yet Recruiting

• 1 other identifier: SYS6026-003
• Study Type: observational
• Target: 186
• Locations: 0 countries
• Sites: N/A

Brief Summary

This trial is a multicenter, open-label, dose exploration and cohort expansion Phase II clinical study designed to evaluate the safety, immunogenicity, and preliminary efficacy of different dosing regimens of SYS6026 injection (hereinafter referred to as "SYS6026") combined with Enlonstobart in patients with unresectable locally advanced or metastatic solid tumors associated with HPV types 16 or 18. The study consists of two phases: dose exploration and cohort expansion.

Conditions

Solid Tumor

Keywords

solid tumors

Outcome Measures

Primary Outcomes (1)

• DLT incidence

  24 Months

Study Arms (2)

SYS6026 + Enlonstobart

SYS6026 + Enlonstobart

Drug: SYS6026 combined with Enlonstobart therapy

SYS6026 + Enlonstobart ± bevacizumab

SYS6026 + Enlonstobart ± bevacizumab

Drug: SYS6026 combined with Enlonstobart therapy

Interventions

SYS6026 combined with Enlonstobart therapy DRUG

SYS6026 combined with Enlonstobart therapy

SYS6026 + Enlonstobart; SYS6026 + Enlonstobart ± bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

participate advanced solid tumors

You may qualify if:

• Age ≥18 years;
• Confirmation by the research center of HPV type 16 and/or 18 infection in tumor tissue;
• Pathologically confirmed unresectable locally advanced or metastatic solid tumor;
• ECOG PS score of 0-1;
• Estimated survival of at least 3 months;
• Normal function of major organs within 1 week prior to the initial vaccination/randomization (no administration of erythrocyte transfusion or hematopoietic stimulation factors \[e.g., granulocyte colony-stimulating factor, erythropoietin, thrombopoietin\] within 14 days before screening, and no platelet transfusion within 7 days before screening):
• ANC≥1.5×109/L；
• PLT≥100×109/L；
• Hb≥90 g/L；
• TBIL≤1.5×ULN，Participants with Gilbert syndrome
• TBIL≤3×ULN；
• ALT和AST≤2.5×ULN；
• Cr≤1.5×ULN，or creatinine clearance≥45 mL/min（Cockcroft-Gault）；
• APTT≤1.5×ULN，PT≤1.5×ULN，INR≤1.5×ULN。
• Eligible participants of reproductive age (both males and females) must agree to use reliable contraceptive methods (hormonal contraceptives, barrier methods, or abstinence) with their partner from the date of signing the informed consent form until 6 months after the last dose administration.

You may not qualify if:

• Tumor tissue testing reveals co-infection with other high-risk HPV types;
• Adverse reactions from prior antitumor therapy have not yet resolved to CTCAE Grade V5.0 level ≤1 (excluding alopecia or participants deemed clinically insignificant by investigators);
• Participation in other clinical trials involving the study drug within 28 days prior to first administration/randomization, excluding observational (non-interventional) trials or follow-up phases of intervention trials;
• Previous long-term (≥7 days) systemic use of immunosuppressants or initial systemic immunosuppressive therapy within 14 days prior to first administration/randomization;
• Patients who have received whole blood, plasma, or immunoglobulin therapy within the past 1 month; those with clinically diagnosed known immunological dysfunction or impairment; or individuals with functional splenectomy or complete splenectomy due to any medical condition..
• First administration of the vaccine/within 28 days prior to randomization, or planned administration of an attenuated live vaccine during the study period.
• During the screening period, patients exhibited systemic active infections (defined as requiring intravenous administration of antibacterial, antifungal, or antiviral medications)..
• Has a severe history of cardiovascular and cerebrovascular diseases, including but not limited to:
• Heart failure classified as grade ≥2 according to the NYHA classification;
• first-time medication use or occurrence of myocardial infarction, treatment-needed arrhythmia, or unstable angina within 6 months prior to randomization;
• first-time medication use or occurrence of arterial/venous thrombosis or embolism (e.g., transient ischemic attack, cerebral hemorrhage, cerebral infarction \[including lacunar infarction\], deep vein thrombosis, or pulmonary embolism) within 6 months prior to randomization;
• QTcF\> 450 ms;
• poorly controlled hypertension (systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 90 mmHg during screening), with a history of hypertensive crisis or hypertensive encephalopathy.
• Patients with active autoimmune diseases or a history of autoimmune disorders (e.g., myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, pituititis, uveitis, etc.) are eligible. Eligible conditions include well-controlled type 1 diabetes mellitus; hypothyroidism requiring only hormone replacement therapy and well-controlled; skin diseases (e.g., vitiligo, psoriasis, alopecia) not requiring systemic treatment; or participants with a predicted low risk of disease recurrence in the absence of external triggers..
• Active hepatitis B (HBsAg-positive with HBV DNA ≥ 500 IU/mL or ≥ 2,500 copies/mL) or hepatitis C (HCV antibody-positive with HCV-RNA quantification ≥ the lower limit of the detection range) (Note: For HBsAg-positive patients, antiviral therapy is recommended prior to initial use of the study drug; nucleoside analogs such as entecavir or tenofovir disoproxil are preferred); co-infection with both HBV and HCV (HBsAg-positive and HCV antibody-positive) is not eligible for enrollment..

Sponsors & Collaborators

• CSPC Megalith Biopharmaceutical Co.,Ltd.: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 6, 2026

Record last verified: 2026-06