Advanced Solid Tumors
Conditions
Brief summary
This is a multicenter, open-label, dose-escalation and backfill, and cohort-expansion phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor efficacy of SYS6051 in participants with advanced solid tumors.
Interventions
DRUGSYS6051
SYS6051 is administered by intravenous infusion every 3 weeks (Q3W). The doses administered for the first and subsequent visits of SYS6051 will be calculated based on the weight at screening/baseline and prior to dosing at subsequent visits.
Sponsors
CSPC Megalith Biopharmaceutical Co.,Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is the first-in-human phase I study of SYS6051 and this study consists of two part: a dose escalation and backfill part and a cohort expansion part.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Fully understand the clinical study and voluntarily sign the written ICF; 2. Age ≥ 18 years; 3. Have at least one measurable lesion according to RECIST 1.1; 4. ECOG performance status score of 0 to 1; 5. Have adequate organ function; 6. Expected survival of at least 3 months; 7. Eligible participants of childbearing potential must agree to use a reliable method of contraception with their partner during the study and for at least 4 months (males) or 7 months (females) after the last dose. Female participants of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose; 8. Histologically or cytologically confirmed diagnosis of advanced solid tumors. -
Exclusion criteria
1\. Presence of high bleeding risk factors; 2. Presence of active ocular disease; 3. Patients with other active malignant tumors; 4. Uncontrolled serous effusions requiring frequent drainage or medical intervention within 14 days prior to the first dose; 5. Serious chronic or active infection; 6. Surgical on vital organs within 4 weeks prior to the first dose or planned systemic or local tumor resection during the study; 7. Untreated (including baseline findings) or unstable parenchymal metastases, spinal cord metastases or compression, carcinomatous meningitis; 8. History of non-infectious lung disease/pneumonitis requiring steroid hormone therapy or current interstitial lung disease/pneumonitis or suspected by imaging during screening; 9. History of significant cardiovascular disease; 10. History of immunodeficiency, Active hepatitis B or hepatitis C; 11. Known serious allergic reactions to the study drug or other ingredients and excipients in the formulation; 12. Pregnant or lactating women; 13. Presence of other conditions that could interfere with the participant 's participation in study procedures or would not be in the best interest of the participant' s participation in the study or affect the study results: such as a history of mental illness, drug use, or drug abuse, any other clinically significant disease or condition. \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity (DLT) | From Day 1 to Day 21 |
| Frequency and severity of AE | From Day 1 to 30 days after last dose. |
| Maximal tolerable dose (MTD) | From Day 1 to 12 months. |
| Recommended phase 2 dose (RP2D) | From Day 1 to 12 months. |
| ORR | From Day 1 to 12 months. |
Secondary
| Measure | Time frame |
|---|---|
| Cmax | From Day 1 to 12 months. |
| AUCss, | From Day 1 to 12 months. |
| ORR | From Day 1 to 12 months. |
| PFS | From Day 1 to 12 months. |
| OS | From Day 1 to 18 months. |
| Positive rate for ADA | From Day 1 to 18 months. |
Contacts
CONTACTClinical Trials Information Group
Outcome results
None listed