Colorectal CancerNCT07104877
A Study of SYS6010 in Combination With SYH2051 in Patients With Advanced Colorectal Cancer and Other Gastrointestinal Tumors
A study testing SYS6010 and SYH2051 in people with Colorectal Cancer and Gastric Cancer (GC), run by Fujian Cancer Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Gastric Cancer (GC), Gastrointestinal Tumors
- What is being tested?
- SYS6010 and SYH2051
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 18 Apr 2024to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of SYH2051 in Combination With SYS6010 in Patients With Gastrointestinal Tumors Such as Advanced Colorectal Cancer
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.
- Being tested
- SYS6010, SYH2051
- Keywords
- SYS6010, SYH2051
- Medical subject headings
- Colorectal Neoplasms, Stomach Neoplasms, Digestive System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYS6010Drug
Administered via intravenous infusion at the dose of 3.2-4.8 mg/kg
SYH2051Drug
Administered via oral at the dose of 40-80 mg
| Study group | Role | What they receive |
|---|---|---|
| SYS6010+SYH2051 | Experimental | Not described Receives: Drug: SYS6010; Drug: SYH2051 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 21 days
Secondary outcomes (5)
Objective response rate (ORR) per RECIST v1.1
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.
Measured: Up to 2 years
Disease Control Rate (DCR)
Measured: Up to 2 years
Duration of Response (DOR)
Measured: Up to 2 years
Progression-free Survival (PFS)
Measured: Up to 2 years
Overall survival (OS)
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start18 Apr 2024
- Primary completion1 Nov 2024
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104877
- Sponsor's protocol ID
- SYH2051-002
- Status last verified
- Jul 2025
- First submitted
- 29 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of SYH2051 in Combination With SYS6010 in Patients With Gastrointestinal Tumors Such as Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07104877
- Acronym / sponsor ID
- SYH2051-002
- Keywords
- SYS6010, SYH2051
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SYS6010+SYH2051 | Experimental | Drug: SYS6010, Drug: SYH2051 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYS6010Administered via intravenous infusion at the dose of 3.2-4.8 mg/kg | Drug | SYS6010+SYH2051 |
| SYH2051Administered via oral at the dose of 40-80 mg | Drug | SYS6010+SYH2051 |
Primary outcome
Adverse Event (AE)
Time frame: 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)
Time frame: Up to 21 days
DLTs are defined as adverse events related to the study drug that meet the protocol-specified criteria for dose limitation.
5 secondary outcomes
Objective response rate (ORR) per RECIST v1.1
Time frame: Up to 2 years
Disease Control Rate (DCR)
Time frame: Up to 2 years
Duration of Response (DOR)
Time frame: Up to 2 years
Progression-free Survival (PFS)
Time frame: Up to 2 years
Overall survival (OS)
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SYS6010 and SYH2051 in people with Colorectal Cancer and Gastric Cancer (GC), run by Fujian Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event (AE) (time frame: Up to 90 days following the last dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.