Advanced Solid Tumors
Conditions
Brief summary
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.
Detailed description
This study is a multicenter, open-label, Phase Ib/II clinical trial with dose-escalation and dose-expansion components, conducted in Chinese patients with advanced malignant solid tumors. In Part A, participants will receive SG1827 in combination with an anti-PD-1/PD-L1 antibody; in Part B, participants will receive SG1827 in combination with an anti-PD-1/PD-L1 antibody and bevacizumab. Part A is designed to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD), immunogenicity, and anti-tumor efficacy of SG1827 plus an anti-PD-1/PD-L1 antibody in advanced solid tumors, while Part B is designed to evaluate the safety, tolerability, PK/PD, immunogenicity, and anti-tumor efficacy of SG1827 combined with an anti-PD-1/PD-L1 antibody and bevacizumab in the same patient population.
Interventions
DRUGSG1827
Intravenous infusion, once every three weeks
Intravenous infusion
DRUGbevacizumab
Intravenous infusion
Sponsors
Hangzhou Sumgen Biotech Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years, male or female. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 3. Life expectancy ≥3 months. 4. 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. 5. At least one measurable lesion per RECIST 1.1 criteria. 6. Adequate organ and bone marrow function. 7. Female participants of childbearing potential and male participants with partners of childbearing potential must use at least one accepted method of contraception during the study treatment period and for at least 5 months (150 days) after the last dose. 8. Male participants must refrain from sperm donation from the time of signing the informed consent form (ICF) until at least 5 months after the last dose.
Exclusion criteria
1. Prior treatment with immunotherapies targeting CTLA 4 and/or CD28 (or agents containing these targets). 2. Presence of active central nervous system (CNS) metastatic lesions. 3. Other malignant tumors within 5 years prior to the first dose. 4. Receipt of any of the following treatments or procedures: 1. Major surgery (other than diagnostic biopsy) within 28 days prior to the first dose; 2. Anti tumor macromolecular antibody therapy or other unmarketed investigational anti tumor therapies within 28 days prior to the first dose; anti tumor chemotherapy, endocrine therapy, or oral small molecule targeted therapy within 14 days prior to the first dose; traditional Chinese medicine preparations approved by the NMPA with anti tumor indications within 7 days prior to the first dose; 3. Curative radiotherapy within 28 days prior to the first dose; palliative radiotherapy is permitted within 14 days prior to the first dose, provided that all related AEs have resolved to ≤ Grade 1 (CTCAE v6.0), except for toxicities such as alopecia that are judged by the investigator to have no safety risk and not to violate other inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AEs | From first dose until 30 days after last dose of SG1827 | Number and percentage of AEs which is calculated by worst CTCAE grade by CTCAE 6.0 |
Countries
China
Contacts
CONTACTYue Song, Bachelor
Outcome results
None listed