An Open-label Study of SG1827 Combined With Anti-PD-1/PD-L1 Antibody and Bevacizumab in Patients With Advanced Solid Tumors

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHangzhou Sumgen Biotech Co., Ltd.

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • SG1827

    Drug

    Intravenous infusion, once every three weeks

  • anti-PD-1/PD-L1 antibody

    Drug

    Intravenous infusion

  • bevacizumab

    Drug

    Intravenous infusion

Treatment groups

180 Participants
are divided into 1 treatment group
Group A: SG1827Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

AEs

Number and percentage of AEs which is calculated by worst CTCAE grade by CTCAE 6.0

Time frame
From first dose until 30 days after last dose of SG1827

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: