A Phase Ib/II Study of SYS6090 Combination Therapy in Advanced Colorectal Cancer (NCT07750041) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Phase Ib/II Study of SYS6090 Combination Therapy in Advanced Colorectal Cancer
China260 participantsStarted 2026-08-30
Plain-language summary
This study constitutes an open-label, multi-cohort, multi-center Phase Ib/II clinical study, developed to assess the safety, tolerability, and therapeutic efficacy of SYS6090 injection when administered in combination with bevacizumab, or in triple combination with bevacizumab and chemotherapy, among patients diagnosed with advanced colorectal cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects must be ≥18 years of age.
. Histologically or cytologically confirmed unresectable advanced or metastatic colorectal cancer with pMMR/MSS status, assigned to corresponding cohorts as follows:
. At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.
. Eastern Cooperative Oncology Group performance status of 0 or 1.
. Expected survival ≥ 3 months.
. Has protocol-defined adequate organ and bone marrow function.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recommended Phase 2 Dose (RP2D), Safety and Tolerability
Timeframe: up to approximately 3 years after the first enrollment
2
Objective Response Rate (ORR) assessed per RECIST v1.1
Timeframe: up to approximately 3 years after the first enrollment
3
Progression-Free Survival (PFS) assessed per RECIST v1.1
Timeframe: up to approximately 3 years after the first enrollment
. Subjects with clinically active central nervous system metastases;
. with a history of other primary malignant tumors within 5 years before administration;
. Subjects assigned to Cohort 1 who have received prior regorafenib treatment.;
. Prior documented interstitial lung disease (ILD)/ pneumonitis that required steroids, current ILD/ pneumonitis, or suspected ILD/ pneumonitis that cannot be ruled out by imaging at screening;
. Uncontrolled or significant cardiovascular disease;
. Clinically uncontrolled pleural effusion, ascites or pericardial effusion;
. Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to Grade ≤ 1 or baseline .