Status:
RECRUITING
SG2918 For Advanced Malignant Tumors
Lead Sponsor:
Hangzhou Sumgen Biotech Co., Ltd.
Conditions:
Advanced Malignant Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 refra...
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,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 28 2026
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT06167486
Start Date
December 26 2023
End Date
December 28 2026
Last Update
June 26 2025
Active Locations (6)
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1
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400000
2
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
3
Hunan Cancer Hospital
Changsha, Hunan, China, 410031
4
Shanghai first maternity and infant hospital
Shanghai, Shanghai Municipality, China, 200126