Colorectal Cancer, Gastric Cancer (GC), Gastrointestinal Tumors
Conditions
Keywords
SYS6010, SYH2051
Brief 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.
Interventions
DRUGSYS6010
Administered via intravenous infusion at the dose of 3.2-4.8 mg/kg
DRUGSYH2051
Administered via oral at the dose of 40-80 mg
Sponsors
Fujian Cancer Hospital
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event (AE) | Up to 90 days following the last dose | Occurrence and frequency of Adverse Event (AE)The occurrence and incidence of adverse events (AEs) will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. AEs will be monitored from the first dose until the safety follow-up period. |
| Dose-limiting toxicities (DLTs) | Up to 21 days | DLTs are defined as adverse events related to the study drug that meet the protocol-specified criteria for dose limitation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DOR) | Up to 2 years | — |
| Objective response rate (ORR) per RECIST v1.1 | Up to 2 years | The objective response rate (ORR) will be assessed based on RECIST v1.1 criteria. ORR is defined as the proportion of patients achieving a complete response (CR) or partial response (PR) as the best overall response. |
| Overall survival (OS) | Up to 2 years | — |
| Progression-free Survival (PFS) | Up to 2 years | — |
| Disease Control Rate (DCR) | Up to 2 years | — |
Countries
China
Outcome results
None listed