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Advanced Solid TumorsPhase 1CSG-1827-101NCT06076291

An Open-label Study of SG1827 in Subjects With Advanced Solid Tumors

A Phase 1 study testing SG1827 in people with Advanced Solid Tumors, run by Hangzhou Sumgen Biotech Co., Ltd. at 6 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase I, open-label, dose escalation and dose expansion study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SG1827 in subjects with Advanced Solid Tumors, refractory or resistant to standard therapy, or without available standard or curative therapy. 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
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
6 sitesChina
Study dates
27 Sep 2023to 18 Mar 2026
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Understand and voluntarily sign the informed consent form (ICF).
  • Age ≥18 years.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
  • Life expectancy ≥3 months.
  • Histologically or cytologically documented advanced or metastatic solid tumors that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available. In the dose-expansion cohorts (Phase 1b), histologically or cytologically confirmed selected advanced solid tumors.
  • Subject must have at least one measurable lesion according to RECIST Version1.1.
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  • Adequate organ function.
  • Toxicity caused by prior anti-tumor therapy recovered to Grade 0 to 1 (CTCAE 5.0).
  • Female patients of childbearing potential and male patients whose female partners are of childbearing potential need to use at least one approved contraceptive (e.g., intrauterine device, pill, or condom) during study treatment and for at least 5 months (150 days) after the last dose; female patients of childbearing potential must have a negative blood human chorionic gonadotropin (HCG) test within 7 days prior to dosing and must not be lactating.
  • Male patients must refrain from donating sperm from the time the ICF is signed until at least 5 months after the last dose.

Who cannot join

  • Subjects with symptomatic central nervous system metastatic lesions; presence of metastases to the brainstem or meninges, spinal cord metastases or compression. Except the subjects who have been treated, be asymptomatic.
  • Active autoimmune disease requiring systemic therapy within the past 2 years (e.g., use of immunomodulatory drugs, corticosteroids, or immunosuppressive medications); related replacement therapy is allowed (e.g., thyroid hormone, insulin, or physiologic corticosteroid replacement for renal or pituitary insufficiency).
  • Have received any of the following treatments or procedures:
  • Prior treatment with any antitumor therapy targeting CTLA-4.
  • Subjects received open surgery within 28 days prior to the first dose (except for surgeries for the purpose of biopsy).
  • Subjects received systemic anticancer therapy (including chemotherapy, targeted therapy, hormonal therapy, immunotherapy and other experimental drugs) within 28 days or 5 drug half-lives (which occurs first) prior to the first dose, and all AEs have not returned to grade ≤1 (CTCAE 5.0).
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  • Subjects received curative radiotherapy within 28 days prior to the first dose; palliative radiotherapy is allowed if which occurs within 14 days prior to the first dose, and all AEs have not returned to grade ≤1 (CTCAE 5.0).
  • Any live vaccine within 28 days prior to the first dose.
  • Prior allogeneic organ grafting or allogeneic stem cell transplantation.
  • Subjects received systemic corticosteroids (equivalent dose > 10 mg/day of prednisone) or other immunosuppressive drugs within 14 days prior to the first dose or will receive during the study. Except topical or prophylactic treatment for non-autoimmune diseases.
  • Presence of active infection requiring antibiotic therapy within 30 days prior to the first dose, except for prophylaxis use.
  • Presence of cardiovascular system disease within 6 months prior to screening that meets any of the following:
  • Cardiac function: congestive heart failure of New York Heart Association (NYHA) class III or IV; left ventricular ejection fraction <50%.
  • Clinically significant cardiac disease or surgery , including myocardial infarction, unstable angina pectoris, coronary/peripheral artery bypass, etc.
  • QTcF >450 ms (corrected QT interval with Fridericia formula); history of clinically significant ventricular arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, tip-twist ventricular tachycardia); history or family history of congenital long QT syndrome; arrhythmias requiring antiarrhythmic drug therapy (patients with atrial fibrillation with controllable heart rate 1 month prior to the first dose of the investigational drug may be enrolled).
  • History of arterial thrombosis, deep venous thrombosis and pulmonary embolism.
  • Hyperglycaemia or Hypertension that has not been effectively controlled after standard treatment.
  • Patients with active hepatitis B or C, or HIV antibody positive.
  • Known history of Grade 3 to 4 hypersensitivity reactions to any biological product, history of life threatening hypersensitivity reactions, or known hypersensitivity to components of SG1906 drug product.
  • History of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapies.
  • Presence of body fluid (hydrothorax, ascites, pericardial effusion, etc.) requiring local treatment or repeated drainage.
  • Immune-related adverse effects leading to permanent discontinuation during previous antineoplastic immunotherapy.
  • Subjects with unhealed wounds.
  • Subjects with high risk of bleeding.
  • Subjects with other malignant solid tumors (except for cured defined tumors) within 5 years prior to the first dose.
  • Any other condition that, in the opinion of the Investigator, may lead to inappropriate participation in this study.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University

    Changsha, Hunan, 410013

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • The Affiliated Hospital of USTC

    Hefei, Anhui, 230001

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110002

  • Henan Cancer Hospital

    Zhenzhou, Henan, 450003

Other trials in China

About this study

Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SG1827 in Subjects With Advanced Solid Tumors

This is a Phase I, open-label, dose escalation and dose expansion study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SG1827 in subjects with Advanced Solid Tumors, refractory or resistant to standard therapy, or without available standard or curative therapy.

Read the detailed description

After a screening period of up to 28 days for each study phase, qualified patients will be enrolled to receive their assigned dose of SG1827, administered every three weeks (Q3W), until disease progression, intolerable toxicity or others, whichever occurs first.

The study consists of a dose escalation phase (Phase 1a) to determine the maximum tolerated dose (MTD), or recommended Phase 2 dose (RP2D) for SG1827 as a single agent, and a dose expansion phase (Phase 1b) in subjects with specific tumor types which will characterize treatment of SG1827 as a single agent at the MTD or RP2D.

Being tested
SG1827

What participants receive

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

  • SG1827Drug

    PhaseⅠa will use an accelerated titration and Bayesian optimal interval (AT-BOIN) design with 7 dose cohorts: 0.02mg/kg, 0.2mg/kg, 1mg/kg, 3mg/kg, 6mg/kg, 10mg/kg, and 15mg/kg by IV infusion. Accelerated titration (1 patient) will be only applied to the first cohort.

Study groups in NCT06076291
Study groupRoleWhat they receive
SG1827ExperimentalSG1827 monotherapy intravenous (IV) infusion - administered every three weeks (Q3W)
Receives: Drug: SG1827

What is being measured

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

  1. Incidence of Treatment-Emergent Adverse Events

    Number and percentage of AEs which is calculated by worst CTCAE grade by CTCAE 5.0

    Measured: Through study completion, an average of one year

  2. MTD/MAD/ RP2D

    MTD/MAD/RP2D will be determined based on the DLTs and safety data.

    Measured: Through study completion, an average of one year

Secondary outcomes (5)

  1. Pharmacokinetics (PK): Cmax

    Cmax to maximum drug concentrationadministration

    Measured: Through study completion, an average of one year

  2. Pharmacokinetics (PK):limination half-life (T1/2)

    limination half-life (T1/2) of the drug after administration.

    Measured: Through study completion, an average of one year

  3. PD endpoints: cytokine levels

    including but not limited to tumor necrosis factor (TNF)-α, interferon gamma (IFN-γ), interleukin (IL)-2, IL-4, IL-6, IL-8, IL-10, IL-1β.

    Measured: Through study completion, an average of one year

  4. Immunogenicity endpoints:

    levels of anti-drug antibodies (ADAs) and neutralizing antibodies (tested in ADA-positive samples only).

    Measured: Through study completion, an average of one year

  5. Efficacy endpoints:

    objective response rate (ORR),

    Measured: Through study completion, an average of one year

Timeline

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

  1. First posted10 Oct 2023
  2. Study start27 Sep 2023
  3. Primary completion18 Mar 2026
  4. Study completion18 Mar 2026

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06076291
Sponsor's protocol ID
CSG-1827-101
Acronym
CSG-1827-101
Status last verified
Jul 2026
First submitted
24 Sep 2023
Last updated
4 Sep 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 study testing SG1827 in people with Advanced Solid Tumors, run by Hangzhou Sumgen Biotech Co., Ltd. at 6 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 10 inclusion and 26 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: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 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.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events (time frame: Through study completion, an average of one year). The study lists 2 primary outcomes in all. 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 NCT06076291.

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 4 Sep 2026.

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