Can a new drug combo shrink advanced colorectal tumors?
NCT ID NCT07750041
First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time
Summary
This trial is testing whether an investigational drug called SYS6090, when combined with standard treatments like bevacizumab and chemotherapy, can safely and effectively treat advanced colorectal cancer that cannot be removed by surgery. The study includes adults with a specific type of colorectal cancer (pMMR/MSS) who have already tried standard therapies. Researchers will measure how well the combination works, including tumor shrinkage and how long patients live without the disease progressing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SYS6090 (an investigational drug) combined with bevacizumab and/or chemotherapy
- What this could lead to
- If successful, this combination could offer a new treatment option for people with advanced colorectal cancer that has not responded to standard therapies.
- What could go wrong
- This is an early-phase trial, so the safety and effectiveness of SYS6090 are not yet established. The combination may cause side effects or may not improve outcomes compared to existing treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 260 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
\*Eligibility Criteria: Inclusion Criteria: 1. Subjects must be ≥18 years of age. 2. Histologically or cytologically confirmed unresectable advanced or metastatic colorectal cancer with pMMR/MSS status, assigned to corresponding cohorts as follows: Cohort 1 (2L/3L) of Phase Ib \& Phase II: Subjects must have disease progression after no more than 2 lines of standard systemic therapy (prior regimens must contain fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy); tumor tissue confirmed as pMMR by IHC or MSS by NGS/PCR; Cohort 2 (1L) of Phase Ib \& Phase II: Subjects have received no prior systemic anti-tumor therapy for advanced disease; tumor tissue confirmed as pMMR by IHC or MSS by NGS/PCR. 3. At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria. 4. Eastern Cooperative Oncology Group performance status of 0 or 1. 5. Expected survival ≥ 3 months. 6. Has protocol-defined adequate organ and bone marrow function. Exclusion Criteria: 1. Subjects with clinically active central nervous system metastases; 2. with a history of other primary malignant tumors within 5 years before administration; 3. Subjects assigned to Cohort 1 who have received prior regorafenib treatment.; 4. 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; 5. Uncontrolled or significant cardiovascular disease; 6. Clinically uncontrolled pleural effusion, ascites or pericardial effusion; 7. Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to Grade ≤ 1 or baseline .
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fujian Cancer Hospital
Fujian, Fuzhou, 350014, China