A Phase I Clinical Study to Evaluate the Safety Tolerability and Preliminary Efficacy of SG2918 in Subjects With Advanced Malignant Tumors
Overview
- Phase
- Phase 1
- Intervention
- SG2918
- Conditions
- Advanced Malignant Tumors
- Sponsor
- Hangzhou Sumgen Biotech Co., Ltd.
- Enrollment
- 17
- Locations
- 6
- Primary Endpoint
- Incidence of Treatment-Emergent Adverse Events
- Status
- Active, Not Recruiting
- Last Updated
- last month
Overview
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 refractory or resistant to standard therapy, or without available standard or curative therapy.
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.
Investigators
Eligibility Criteria
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;
Arms & Interventions
SG2918
SG2918 monotherapy
Intervention: SG2918
Outcomes
Primary Outcomes
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
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.
Secondary Outcomes
- Pharmacokinetics (PK): CL(From the time of first dose until 30 days after last dose of SG2918)
- Efficacy endpoints(Through study completion, an average of one year，assessed up to approximately 12 months)
- Pharmacokinetics(PK): Cmax(From the time of first dose until 30 days after last dose of SG2918)
- Pharmacokinetics (PK): AUC(From the time of first dose until 30 days after last dose of SG2918)
- Pharmacodynamic(PD): cellular biomarkers(From the time of first dose until 30 days after last dose of SG2918)
- Immunogenicity endpoints(Through study completion, an average of one year，assessed up to approximately 12 months)
- Pharmacokinetics (PK): T1/2(From the time of first dose until 30 days after last dose of SG2918)
- Pharmacodynamic(PD): cytokine levels(From the time of first dose until 30 days after last dose of SG2918)