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

Sponsor
CSPC Megalith Biopharmaceutical Co.,Ltd.
Study ID
NCT07684261
Status
Not Yet Recruiting

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Conditions

  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SYS6026 combined with Enlonstobart therapy — DRUG
    SYS6026 combined with Enlonstobart therapy

Study Details

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.

Key Dates

First listed
Jul 6, 2026
Start date
Jul 20, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
186 participants (estimated)

Arms

  • Arm: SYS6026 + Enlonstobart
    SYS6026 + Enlonstobart
  • Arm: SYS6026 + Enlonstobart ± bevacizumab
    SYS6026 + Enlonstobart ± bevacizumab

Primary Outcome Measure

DLT incidence [ Time Frame: 24 Months ]

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