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

Not Applicable

Active, not recruiting

• Conditions: Colorectal Cancer; Gastric Cancer (GC); Gastrointestinal Tumors
• Interventions: Drug: SYS6010; Drug: SYH2051

• Registration Number: NCT07104877
• Lead Sponsor: Fujian Cancer Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-18
• Primary Completion: 2024-11-01
• Status Verified: 2025-07
• Study First Submitted: 2025-07-29
• Study First Submitted QC: 2025-07-29
• Last Update Submitted: 2025-07-29
• Study First Posted: 2025-08-05
• Last Update Posted: 2025-08-05
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
SYS6010+SYH2051	SYS6010	-
SYS6010+SYH2051	SYH2051	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Disease Control Rate (DCR)	Up to 2 years
Duration of Response (DOR)	Up to 2 years
Progression-free Survival (PFS)	Up to 2 years
Overall survival (OS)	Up to 2 years

Trial Locations

Locations (1)

Fujian Provincial Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China