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

Sponsor
Hangzhou Sumgen Biotech Co., Ltd.
Study ID
NCT07774611
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced Solid Tumors

Eligibility Criteria

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

Interventions

  • SG1827 — DRUG
    Intravenous infusion, once every three weeks
  • anti-PD-1/PD-L1 antibody — DRUG
    Intravenous infusion
  • bevacizumab — DRUG
    Intravenous infusion

Study Details

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.

Key Dates

First listed
Aug 19, 2026
Start date
Sep 22, 2026
Status verified
Aug 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
180 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SG1827
    Part A employs a Bayesian Optimal Interval (BOIN) design for dose escalation, with six dose levels of SG1827 (0.3, 1, 3, 6, 10, and 15 mg/kg), starting at 0.3 mg/kg and escalating sequentially from low to high. In Part B, the starting dose of SG1827 in combination with an anti-PD-1/PD-L1 antibody and bevacizumab will be determined by the SMC based on available results from Part A, using a dose-finding strategy that includes a safety run-in cohort followed by adaptive dose de-escalation.

Primary Outcome Measure

AEs [ Time Frame: From first dose until 30 days after last dose of SG1827 ]

Central Contacts

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