A Study of SYS6051 in Subjects With Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SYS6051.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SYS6051 in Patients With Advanced Solid Tumors
Overview
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
- Drug SYS6051
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.
Primary outcome measures
- Dose limiting toxicity (DLT) [Time frame: From Day 1 to Day 21]
- Frequency and severity of AE [Time frame: From Day 1 to 30 days after last dose.]
- Maximal tolerable dose (MTD) [Time frame: From Day 1 to 12 months.]
- Recommended phase 2 dose (RP2D) [Time frame: From Day 1 to 12 months.]
- ORR [Time frame: From Day 1 to 12 months.]
Secondary outcome measures (6)
- Cmax [Time frame: From Day 1 to 12 months.]
- AUCss, [Time frame: From Day 1 to 12 months.]
- ORR [Time frame: From Day 1 to 12 months.]
- PFS [Time frame: From Day 1 to 12 months.]
- OS [Time frame: From Day 1 to 18 months.]
- Positive rate for ADA [Time frame: From Day 1 to 18 months.]
Eligibility criteria
Inclusion criteria
- Fully understand the clinical study and voluntarily sign the written ICF;
- Age ≥ 18 years;
- Have at least one measurable lesion according to RECIST 1.1;
- ECOG performance status score of 0 to 1;
- Have adequate organ function;
- Expected survival of at least 3 months;
- 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;
- 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.
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07591285 · SYS6051-001