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Advanced Solid TumorsPhase 1/2NCT07774611

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

A Phase 1/2 study testing SG1827, anti-PD-1/PD-L1 antibody and bevacizumab in people with Advanced Solid Tumors, run by Hangzhou Sumgen Biotech Co., Ltd. at 10 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
SG1827, anti-PD-1/PD-L1 antibody and bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
10 sitesChina
Study dates
22 Sep 2026to 31 Dec 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • At least one measurable lesion per RECIST 1.1 criteria.
  • Adequate organ and bone marrow function.
  • 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.
  • 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.

Who cannot join

  • 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.
  • Receipt of any of the following treatments or procedures:
  • Major surgery (other than diagnostic biopsy) within 28 days prior to the first dose;
  • 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;
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  • 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/exclusion criteria;
  • Vaccination with any live vaccine within 28 days prior to the first dose, or planned vaccination with any live vaccine during the study treatment period;
  • History of allogeneic organ transplantation or allogeneic stem cell transplantation.
  • Use of systemic corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressive agents within 14 days prior to the first dose or during the study period.
  • Active infection requiring intravenous or oral antibiotic therapy within 14 days prior to the first dose, with the exception of prophylactic use.
  • Severe cardiovascular or cerebrovascular disease within 6 months prior to the first dose.
  • Participants with active hepatitis B or hepatitis C, or human immunodeficiency virus (HIV) infection.
  • Known allergy to any component of the study drug, or history of Grade 3 4 allergic reactions to any biologic product, or history of life threatening hypersensitivity.
  • Immune related adverse reactions that led to permanent discontinuation of prior anti tumor immunotherapy.
  • Current or prior history of idiopathic pulmonary fibrosis or idiopathic pneumonia; current active pulmonary disease, interstitial lung disease or pneumonitis (excluding radiation induced localized interstitial pneumonia), pulmonary fibrosis, etc.; history of tracheal fistula; severe dyspnea, pulmonary insufficiency, or requiring continuous oxygen supplementation.
  • Uncontrolled pleural, peritoneal, or pericardial effusion requiring repeated drainage or with significant symptoms within 14 days prior to the first dose.
  • Psychiatric disorders or poor compliance.
  • Female participants who are pregnant or breastfeeding.
  • Any other condition that, in the investigator's opinion, would make the participant unsuitable for participation in the study.

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yue Song, Bachelor contact

+86 18511021364

songyue@sumgenbio.com

10 sites in 1 country

China10 sites

  • Jilin Cancer Hospital

    Changchun, Jilin

    Haifeng Liu, Doctor

  • Hunan Cancer Hospital

    Changsha, Hunan

    Yongchang Zhang, Doctor

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

    Chao Deng, Doctor

  • The Affiliated Hospital of Chengde Medical University

    Chengde, Hebei

    Qingshan Li, Doctor

    Xiaoqin Zhu, Doctor

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality

    Yi Gong, Doctor

  • Dongguan People's Hospital

    Dongguan

    Ruinian Zheng, Doctor

    Zhigang Liu, Doctor

  • Fujian Cancer Hospital

    Fuzhou, Fujian

  • Sun Yat-sen University Cancer Center

    Guanzhou, Guangdong, 510060

    Ruihua Xu, Doctor, xurh@sysucc.org.cn

  • Harbin Medical University Cencer Hospital

    Haerbin, Heilongjiang

    Tongsen Zheng, Doctor

  • The First Affiliated Hospital of Henan Medical University

    Xinxiang, Henan

    Liuzhong Yang, Doctor

Other trials in China

About this study

Official title: A Phase 1b/2 Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of SG1827 for Injection in Combination With Anti-PD-1/PD-L1 Antibody and Bevacizumab in Patients With Advanced Malignant Solid Tumors

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.

Read the 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.

Being tested
SG1827, anti-PD-1/PD-L1 antibody, bevacizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SG1827Drug

    Intravenous infusion, once every three weeks

  • anti-PD-1/PD-L1 antibodyDrug

    Intravenous infusion

  • bevacizumabDrug

    Intravenous infusion

Study groups in NCT07774611
Study groupRoleWhat they receive
SG1827ExperimentalPart 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.
Receives: Drug: SG1827; Drug: anti-PD-1/PD-L1 antibody; Drug: bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AEs

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

    Measured: From first dose until 30 days after last dose of SG1827

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2026
  2. Study start22 Sep 2026 (estimated)
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07774611
Sponsor's protocol ID
CSG-1827-102
Status last verified
Aug 2026
First submitted
13 Aug 2026
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SG1827, anti-PD-1/PD-L1 antibody and bevacizumab in people with Advanced Solid Tumors, run by Hangzhou Sumgen Biotech Co., Ltd. at 10 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yue Song, Bachelor (+86 18511021364, songyue@sumgenbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AEs (time frame: From first dose until 30 days after last dose of SG1827). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07774611.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.

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