Clinical trial · Interventional
A Study of SYS6051 in Subjects With Advanced Solid Tumors
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SYS6051 in Patients With Advanced Solid Tumors
NCT07591285CI-TRIAL-00111733not yet recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SYS6051 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SYS6051
- interventionNames
- Drug: SYS6051
Primary outcomes (5)
- measure
- Dose limiting toxicity (DLT)
- timeFrame
- From Day 1 to Day 21
- measure
- Frequency and severity of AE
- timeFrame
- From Day 1 to 30 days after last dose.
- measure
- Maximal tolerable dose (MTD)
- timeFrame
- From Day 1 to 12 months.
- measure
- Recommended phase 2 dose (RP2D)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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. \-
References
Publications (0)
Data not yet available
No reference posted for this study.