SG2918 For Advanced Malignant Tumors
Sponsored by Hangzhou Sumgen Biotech Co., Ltd.
About this trial
Last updated 2 months ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Started 2 years ago
What is this trial about?
What are the participation requirements?
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
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.
