- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06167486
SG2918 For Advanced Malignant Tumors
March 26, 2024 updated by: Hangzhou Sumgen Biotech Co., Ltd.
A Phase I Clinical Study to Evaluate the Safety Tolerability and Preliminary Efficacy of SG2918 in Subjects With Advanced Malignant Tumors
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Estimated)
117
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhengbo Song, Docter
- Phone Number: 86-13857153345
- Email: songzb@zjcc.org.cn
Study Locations
-
-
Chongqing
-
Chongqing, Chongqing, China, 400000
- Recruiting
- Chongqing University Cancer Hospital
-
Contact:
- Yi Gong
- Phone Number: 86-13228685295
- Email: gongyi_95@163.com
-
-
Henan
-
Zhengzhou, Henan, China, 450003
- Recruiting
- Henan Cancer Hospital
-
Contact:
- Jufeng Wang
- Phone Number: 86-13783583966
- Email: 13783583966@163.com
-
-
Hunan
-
Changsha, Hunan, China, 410031
- Recruiting
- Hunan Cancer Hospital
-
Contact:
- Yongchang Zhang
- Phone Number: 86-13873123436
- Email: zhangyongchang@hnca.org.cn
-
-
Shanghai
-
Shanghai, Shanghai, China, 200126
- Recruiting
- Shanghai first maternity and infant hospital
-
Contact:
- Yu Wang
- Phone Number: 86-18918358318
- Email: renjiwangyu@126.com
-
-
Shanxi
-
Taiyuan, Shanxi, China, 30013
- Recruiting
- Shanxi Provincial Cancer Hospital
-
Contact:
- Xin Wang
- Phone Number: 86-13811176181
- Email: wxcams@126.com
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310005
- Recruiting
- Zhejiang Cancer Hospital
-
Contact:
- Zhengbo Song, Docter
- Phone Number: 86-13857153345
- Email: songzb@zjcc.org.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Histologically or cytologically documented advanced malignant tumors that is refractory/relapsed to standard therapies;
- Adequate organ function;
- ECOG Performance Status score of 0 or 1;
- Must have at least one measurable lesion according to RECIST Version1.1;
- Toxicity caused by prior anti-tumor therapy recovered to Grade 0 to 1 (CTCAE 5.0);
- 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:
- Has active central nervous system metastatic lesions;
- Has Active autoimmune disease requiring systemic therapy within the past 2 years;
- Has Grade 2 and above peripheral neuropathy;
- Has an active infection requiring systemic therapy;
- 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%;
- 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);
- Has known human immunodeficiency virus (HIV) and/or hepatitis B or C infections;
- Has a history of potent CYP3A4 inhibitor with 2 weeks;
- Has received systemic anticancer therapy, radiotherapy, or surgery within 4 weeks before the start of study treatment;
- Have received previous treatment targeted LILRB4 or MMAE experiencing serious adverse events;
- Have received previous immunotherapy experiencing serious adverse events that leading to permanent discontinuation;
- Have received systemic corticosteroids (equivalent dose > 10 mg/day of prednisone) or other immunosuppressive drugs within 14 days prior to the first dose;
- Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody (mAB) and or any components of the study intervention;
- Any live vaccine within 28 days prior to the first dose;
- Has a history of interstitial lung disease or active pneumonia or tracheal fistula; uncontrolled pleural, abdominal and pericardial effusion;
- Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 year.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SG2918
SG2918 monotherapy
|
The SG2918 will be administrated by intravenous infusion every 3 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Treatment-Emergent Adverse Events
Time Frame: From the time of first dose until 30 days after last dose of SG2918
|
Number and percentage of AEs which is calculated by worst CTCAE grade by CTCAE 5.0
|
From the time of first dose until 30 days after last dose of SG2918
|
Number of Participants Who Experience a Dose-Limiting Toxicity (DLT)
Time Frame: Cycle 1 (up to 21 days)
|
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.
|
Cycle 1 (up to 21 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics(PK): Cmax
Time Frame: From the time of first dose until 30 days after last dose of SG2918
|
Maximum drug concentration after administration
|
From the time of first dose until 30 days after last dose of SG2918
|
Pharmacokinetics (PK): AUC
Time Frame: From the time of first dose until 30 days after last dose of SG2918
|
Area Under the Curve of the drug after administration
|
From the time of first dose until 30 days after last dose of SG2918
|
Pharmacokinetics (PK): T1/2
Time Frame: From the time of first dose until 30 days after last dose of SG2918
|
Elimination half-life of the drug after administration
|
From the time of first dose until 30 days after last dose of SG2918
|
Pharmacokinetics (PK): CL
Time Frame: From the time of first dose until 30 days after last dose of SG2918
|
Clearance of the drug after administration
|
From the time of first dose until 30 days after last dose of SG2918
|
Pharmacodynamic(PD): cellular biomarkers
Time Frame: From the time of first dose until 30 days after last dose of SG2918
|
cellular biomarkers including CD4+ T cells, CD8+ T cells, Myeloid-derived suppressor cells (MDSCs) and Regulatory T cells (Tregs)
|
From the time of first dose until 30 days after last dose of SG2918
|
Pharmacodynamic(PD): cytokine levels
Time Frame: From the time of first dose until 30 days after last dose of SG2918
|
Peripheral blood cytokine levels including measurements for TNF-α,IFN-γ,IL-2,IL-4、IL-6,IL-8,IL-10,IL-1β
|
From the time of first dose until 30 days after last dose of SG2918
|
Immunogenicity endpoints
Time Frame: Through study completion, an average of one year,assessed up to approximately 12 months
|
Levels of anti-drug antibodies(ADAs) and neutralizing antibodies (tested in ADA-positive samples)
|
Through study completion, an average of one year,assessed up to approximately 12 months
|
Efficacy endpoints
Time Frame: Through study completion, an average of one year,assessed up to approximately 12 months
|
objective response rate (ORR)
|
Through study completion, an average of one year,assessed up to approximately 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 26, 2023
Primary Completion (Estimated)
December 28, 2025
Study Completion (Estimated)
December 28, 2026
Study Registration Dates
First Submitted
November 21, 2023
First Submitted That Met QC Criteria
December 4, 2023
First Posted (Actual)
December 12, 2023
Study Record Updates
Last Update Posted (Actual)
March 27, 2024
Last Update Submitted That Met QC Criteria
March 26, 2024
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSG-2918-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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