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CompletedNCT06167486Updated Sep 4, 2026

SG2918 For Advanced Malignant Tumors

A Phase 1 interventional study of SG2918 in Advanced Malignant Tumors, sponsored by Hangzhou Sumgen Biotech Co., Ltd.. Completed at 6 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by Hangzhou Sumgen Biotech Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This is a Phase I, open-label, dose escalation and dose expansion study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SG2918 in subjects with Advanced Malignant Tumors who are refractory or resistant to standard therapy, or without available standard or curative therapy.

Read the detailed description

The study consists of dose escalation and dose expansion, the dose escalation will be performed in a standard 3+3 manner at the dose of 0.1mg/kg、0.5mg/kg、1 mg/kg、1.5mg/kg、2 mg/kg、2.5mg/kg and 3 mg/kg, and the dose expansion will be done in specific tumor types. Patients enrolled in the study will receive SG2918 treatment every three weeks (Q3W), until disease progression, intolerable toxicity or others, whichever occurs first.

02

Conditions studied

  • Advanced Malignant Tumors
03

In context

Lead sponsor

Hangzhou Sumgen Biotech Co., Ltd. is the lead sponsor of 12 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Histologically or cytologically documented advanced malignant tumors that is refractory/relapsed to standard therapies;
  2. Adequate organ function;
  3. ECOG Performance Status score of 0 or 1;
  4. Must have at least one measurable lesion according to RECIST Version1.1;
  5. Toxicity caused by prior anti-tumor therapy recovered to Grade 0 to 1 (CTCAE 5.0);
  6. Must have an effective contraception during the study, starting with the Screening Visit through 7 months after the last dose of study intervention.

Exclusion criteria

Exclusion Criteria:

  1. Has active central nervous system metastatic lesions;
  2. Has Active autoimmune disease requiring systemic therapy within the past 2 years;
  3. Has Grade 2 and above peripheral neuropathy;
  4. Has an active infection requiring systemic therapy;
  5. Has a history of any of the following cardiovascular conditions within 6 months of dosing: myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, coronary artery bypass graft, pulmonary embolism, etc; has New York Heart Association (NYHA) Class II and above congestive heart failure; LVEF\<50%;
  6. Has a history of hypertensive crisis or hypertensive encephalopathy; Uncontrolled hypertension though standard treatment within 14 days before the first dose (systolic blood pressure≥160 mmHg and/or diastolic blood pressure≥100mmHg);
  7. Has known human immunodeficiency virus (HIV) and/or hepatitis B or C infections;
  8. Has a history of potent CYP3A4 inhibitor with 2 weeks;
  9. Has received systemic anticancer therapy, radiotherapy, or surgery within 4 weeks before the start of study treatment;
  10. Have received previous treatment targeted LILRB4 or MMAE experiencing serious adverse events;
  11. Have received previous immunotherapy experiencing serious adverse events that leading to permanent discontinuation;
  12. Have received systemic corticosteroids (equivalent dose > 10 mg/day of prednisone) or other immunosuppressive drugs within 14 days prior to the first dose;
  13. Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody (mAB) and or any components of the study intervention;
  14. Any live vaccine within 28 days prior to the first dose;
  15. Has a history of interstitial lung disease or active pneumonia or tracheal fistula; uncontrolled pleural, abdominal and pericardial effusion;
  16. Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 year.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    SG2918

    SG2918 monotherapy

    Drug: SG2918

Interventions

  • DrugSG2918

    The SG2918 will be administrated by intravenous infusion every 3 weeks

06

What researchers measure

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events

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

    Time frame: From the time of first dose until 30 days after last dose of SG2918

  2. Number of Participants Who Experience a Dose-Limiting Toxicity (DLT)

    DLTs will be assessed during the dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria and assessed as related to study drug, and unrelated to disease, disease progression, intercurrent illness or concomitant medications that occurs within the first cycle (three weeks) of treatment.

    Time frame: Cycle 1 (up to 21 days)

Secondary outcomes

  1. Pharmacokinetics(PK): Cmax

    Maximum drug concentration after administration

    Time frame: From the time of first dose until 30 days after last dose of SG2918

  2. Pharmacokinetics (PK): AUC

    Area Under the Curve of the drug after administration

    Time frame: From the time of first dose until 30 days after last dose of SG2918

  3. Pharmacokinetics (PK): T1/2

    Elimination half-life of the drug after administration

    Time frame: From the time of first dose until 30 days after last dose of SG2918

  4. Pharmacokinetics (PK): CL

    Clearance of the drug after administration

    Time frame: From the time of first dose until 30 days after last dose of SG2918

  5. Pharmacodynamic(PD): cellular biomarkers

    cellular biomarkers including CD4+ T cells, CD8+ T cells, Myeloid-derived suppressor cells (MDSCs) and Regulatory T cells (Tregs)

    Time frame: From the time of first dose until 30 days after last dose of SG2918

  6. Pharmacodynamic(PD): cytokine levels

    Peripheral blood cytokine levels including measurements for TNF-α，IFN-γ，IL-2，IL-4、IL-6，IL-8，IL-10，IL-1β

    Time frame: From the time of first dose until 30 days after last dose of SG2918

  7. Immunogenicity endpoints

    Levels of anti-drug antibodies(ADAs) and neutralizing antibodies (tested in ADA-positive samples)

    Time frame: Through study completion, an average of one year，assessed up to approximately 12 months

  8. Efficacy endpoints

    objective response rate (ORR)

    Time frame: Through study completion, an average of one year，assessed up to approximately 12 months

07

Study locations

6 sites
  • Chongqing University Cancer Hospital
    Chongqing, Chongqing Municipality 400000, China
  • Henan Cancer Hospital
    Zhengzhou, Henan 450003, China
  • Hunan Cancer Hospital
    Changsha, Hunan 410031, China
  • Shanghai first maternity and infant hospital
    Shanghai, Shanghai Municipality 200126, China
  • Shanxi Provincial Cancer Hospital
    Taiyuan, Shanxi 30013, China
  • Zhejiang Cancer Hospital
    Hangzhou, Zhejiang 310005, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06167486
Lead sponsor
Hangzhou Sumgen Biotech Co., Ltd.
Responsible party
Sponsor
First posted
Dec 12, 2023
Start date
Dec 26, 2023
Primary completion
Nov 11, 2025
Completion
Nov 11, 2025
Last update
Sep 4, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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