About this trial
This multicenter, open-label Phase Ib/II study with dose escalation and expansion in Chinese patients with advanced solid tumors consists of Part A (SG1827 plus anti-PD-1/PD-L1) and Part B (SG1827 plus anti-PD-1/PD-L1 and bevacizumab), both evaluating safety, tolerability, PK/PD, immunogenicity, and antitumor efficacy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years, male or female.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Life expectancy ≥3 months.
Histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumor. Participants enrolled in the dose escalation phase must have received prior systemic therapy, with disease progression or intolerance to the last line of treatment.
Disqualifiers
Prior treatment with immunotherapies targeting CTLA 4 and/or CD28 (or agents containing these targets).
Presence of active central nervous system (CNS) metastatic lesions.
Other malignant tumors within 5 years prior to the first dose.
Major surgery (other than diagnostic biopsy) within 28 days prior to the first dose;
Trial design
Single group
Treatments tested in this trial
SG1827
DrugIntravenous infusion, once every three weeks
anti-PD-1/PD-L1 antibody
DrugIntravenous infusion
bevacizumab
DrugIntravenous infusion
Treatment groups
Trial outcomes
Primary outcomes
AEs
Number and percentage of AEs which is calculated by worst CTCAE grade by CTCAE 6.0
Sponsors and contacts
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