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

NCT07104877 | Active Not Recruiting

• 1 other identifier: SYH2051-002
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Gastric Cancer (GC); Gastrointestinal Tumors

Keywords

SYS6010; SYH2051

Outcome Measures

Primary Outcomes (2)

• Adverse Event (AE)

  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.

  Up to 90 days following the last dose

• Dose-limiting toxicities (DLTs)

  DLTs are defined as adverse events related to the study drug that meet the protocol-specified criteria for dose limitation.

  Up to 21 days

Secondary Outcomes (5)

• Objective response rate (ORR) per RECIST v1.1

  Up to 2 years

• 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

Study Arms (1)

SYS6010+SYH2051

EXPERIMENTAL

Drug: SYS6010; Drug: SYH2051

Interventions

SYS6010 DRUG

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

SYS6010+SYH2051

SYH2051 DRUG

Administered via oral at the dose of 40-80 mg

SYS6010+SYH2051

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (1)

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Stomach Neoplasms; Digestive System Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: April 18, 2024
• Primary Completion: November 1, 2024
• Study Completion: April 30, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-07

Locations

CN (1)