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Clinical Trials in China / NCT07104877
Active, not recruiting Not applicable

A Study of SYS6010 in Combination With SYH2051 in Patients With Advanced Colorectal Cancer and Other Gastrointestinal Tumors

NCT07104877 · tracked via the Priya Life Science China tracker
Sponsor
Fujian Cancer Hospital
Phase
Not applicable
Started
2024-04-18
Last updated
2025-08-05

Condition(s) studied

Colorectal CancerGastric Cancer (GC)Gastrointestinal Tumors

Investigational drug(s) / intervention(s)

SYS6010 →SYH2051

SYS6010: Administered via intravenous infusion at the dose of 3.2-4.8 mg/kg

SYH2051: Administered via oral at the dose of 40-80 mg

Study summary

This study is an open-label, non-randomized trial design, including a dose escalation phase and a dose expansion phase, to evaluate the safety, tolerability and preliminary anti-tumor activity of SYS6010 in combination with SYH2051 in patients with advanced gastrointestinal tumors.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥18 years. * Patients with unresectable or metastatic colorectal cancer or other gastrointestinal tumors confirmed by histology or pathology, who have failed at least first-line standard therapy or for whom standard treatment is not applicable. * Provide tumor tissue samples for immunohistochemical EGFR expression testing, with EGFR expression positive as confirmed by the central laboratory. * At least one measurable lesion confirmed according to RECIST v 1.1 criteria. * ECOG performance status score of 0-1. * Expected survival of ≥3 months. * Major organ functions must meet relevant laboratory criteria for blood counts, renal function, liver function, and coagulation within 7 days prior to treatment. * Subjects agree to use effective contraception during the study and for 6 months after the last dose, with women being non-lactating and men refraining from sperm donation. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first administration of the study drug. * Willing to participate in the study, understand the study procedures, and sign a written informed consent form. Exclusion Criteria: * Previously treated with antibody-drug conjugates (ADC) containing topoisomerase I inhibitors. * Failure to meet the required washout period for prior medications or treatments as specified in the protocol.. * Has other primary malignancies within 3 years prior to the first dose of the study drugs. * History of severe cardio-cerebrovascular disease. * Adverse events from prior anti-tumor treatments that have not resolved to ≤ Grade 1 of CTCAE V5.0. * Patients with active central nervous system and/or leptomeningeal metastases. * Clinically significant pleural effusion, peritoneal effusion, or pericardial effusion requiring intervention. * Has a history of Interstitial lung disease (ILD)/non-infectious pneumonitis that required steroids, has current ILD/non-infectious pneumonitis, or where suspected ILD/non-infectious pneumonitis cannot be ruled out by imaging at screening. * Patients with thyroid dysfunction requiring treatment, but that well-controlled was allowed. * Severe infections within 4 weeks prior to the first administration of the study drugs. * Prior interruption of EGFR-targeted therapy due to skin toxicity, or skin diseases requiring oral or intravenous treatment currently. * Known allergy to any component of SYS6010 or SYH2051, or any humanized monoclonal antibody product. * Severe ophthalmic history (e.g., dry eye syndrome, keratitis, conjunctivitis, etc.). * Had a history of autoimmune disease (except tuberous sclerosis), immunodeficiency (including positive HIV test), or other acquired or congenital immunodeficiency diseases, or organ transplantation. * Active HBV, HCV infection or syphilis infection. * Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fujian Provincial Cancer Hospital Fuzhou Fujian

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07104877 on ClinicalTrials.gov ↗ ← All trials in China