Unresectable Advanced or Metastatic Colorectal CancerPhase 1/2NCT07750041

A Phase Ib/II Study of SYS6090 Combination Therapy in Advanced Colorectal Cancer

A Phase 1/2 study testing SYS6090 (Fixed Dose Level A) + bevacizumab, SYS6090 (Fixed Dose Level B ) + bevacizumab and SYS6090 RP2D + bevacizumab +mFOLFOX6 in people with Unresectable Advanced or Metastatic Colorectal Cancer, run by CSPC Megalith Biopharmaceutical Co.,Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Unresectable Advanced or Metastatic Colorectal Cancer
What is being tested?: SYS6090 (Fixed Dose Level A) + bevacizumab, SYS6090 (Fixed Dose Level B ) + bevacizumab and SYS6090 RP2D + bevacizumab +mFOLFOX6
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 260 participants
Where: 1 siteChina
Study dates: 30 Aug 2026to 30 Aug 2029
Phase: Phase 1/2
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

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:
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.
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.

Who cannot join

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 .

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Information Group officer contact

0311-69085587

ctr-contact@cspc.cn

LIN contact

China1 site

Fujian Cancer Hospital
Fujian, Fuzhou, 350014
Rong-Bo Lin, PhD, +86 13705919382, linrongbo@fjzlhospital.com

Other trials in China

About this study

Official title: A Phase Ib/II Study to Evaluate the Safety, Tolerability, and Efficacy of SYS6090 in Combination With Other Therapies in Participants With Advanced Coloretal Cancer

Conditions: Unresectable Advanced or Metastatic Colorectal Cancer
Being tested: SYS6090 (Fixed Dose Level A) + bevacizumab, SYS6090 (Fixed Dose Level B ) + bevacizumab, SYS6090 RP2D + bevacizumab +mFOLFOX6, SYS6090 RP2D + bevacizumab, Regorafenib
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SYS6090 (Fixed Dose Level A) + bevacizumabDrug
Participants will receive intravenous SYS6090 at fixed dose level A combined with intravenous bevacizumab, administered per cycle schedule specified in study protocol, for advanced/palliative unresectable pMMR/MSS colorectal cancer.
SYS6090 (Fixed Dose Level B ) + bevacizumabDrug
Participants will receive intravenous SYS6090 at fixed dose level B plus intravenous bevacizumab per protocol-defined cycle schedule for unresectable advanced pMMR/MSS colorectal cancer.
SYS6090 RP2D + bevacizumab +mFOLFOX6Drug
Participants will receive intravenous SYS6090 at RP2D plus intravenous bevacizumab combined with standard mFOLFOX6 chemotherapy regimen (oxaliplatin, leucovorin, fluorouracil), administered per protocol-defined cycle schedule for unresectable advanced pMMR/MSS colorectal cancer.
SYS6090 RP2D + bevacizumabDrug
Participants will receive intravenous SYS6090 at RP2D plus intravenous bevacizumab, administered per protocol-defined cycle schedule for unresectable advanced pMMR/MSS colorectal cancer.
RegorafenibDrug
Oral regorafenib monotherapy as standard control for metastatic pMMR/MSS colorectal cancer.
SYS6090 PR2D+ bevacizumab + FOLFOXIRIDrug
Participants will receive intravenous SYS6090at RP2D plus intravenous bevacizumab combined with FOLFOXIRI triple chemotherapy (oxaliplatin, irinotecan, leucovorin, fluorouracil) per study cycle schedule for metastatic pMMR/MSS colorectal cancer.
bevacizumab + FOLFOXIRIDrug
Participants will receive intravenous bevacizumab combined with FOLFOXIRI triple chemotherapy (oxaliplatin, irinotecan, leucovorin, fluorouracil) per study cycle schedule for metastatic pMMR/MSS colorectal cancer.

Study groups in NCT07750041
Study group	Role	What they receive
Ib-Randomized Arm 1	Experimental	Enrolled Subjects will be randomized to receive SYS6090 at the fixed dose level A in combination with bevacizumab. The exact dose magnitude and administration frequency of SYS6090 are temporarily undisclosed to protect pending patent information, with full dosing details archived in platform backend for regulatory review only. Receives: Drug: SYS6090 (Fixed Dose Level A) + bevacizumab
Ib-Randomized Arm 2	Experimental	Enrolled Subjects will be randomized to receive SYS6090 at the fixed dose level B in combination with bevacizumab. The exact dose magnitude and administration frequency of SYS6090 are temporarily undisclosed to protect pending patent information, with full dosing details archived in platform backend for regulatory review only. Receives: Drug: SYS6090 (Fixed Dose Level B ) + bevacizumab
II-Cohort 1- Randomized Arm A	Experimental	Enrolled Subjects will be randomized to receive SYS6090 at RP2D combined with bevacizumab and mFOLFOX6 Receives: Drug: SYS6090 RP2D + bevacizumab +mFOLFOX6
II-Cohort 1- Randomized Arm B	Experimental	Enrolled Subjects will be randomized to receive SYS6090 at RP2D combined with bevacizumab Receives: Drug: SYS6090 RP2D + bevacizumab
II-Cohort 1- Randomized Arm C	Experimental	Enrolled Subjects will be randomized to receive regorafenib Receives: Drug: Regorafenib
II-Cohort 2- Randomized Arm D	Experimental	Enrolled Subjects will be randomized to receive SYS6090 at RP2D combined with bevacizumab and FOLFOXIRI Receives: Drug: SYS6090 PR2D+ bevacizumab + FOLFOXIRI
II-Cohort 2- Randomized Arm E	Active comparator	Enrolled Subjects will be randomized to receive bevacizumab combined with FOLFOXIRI Receives: Drug: bevacizumab + FOLFOXIRI

What is being measured

The primary outcome is the main question the study is designed to answer.

Recommended Phase 2 Dose (RP2D), Safety and Tolerability
RP2D of SYS6090 combination therapy,Safety and tolerability are evaluated via incidence and severity of all Adverse Events (AEs) and Serious Adverse Events (SAEs) graded per NCI-CTCAE version 6.0, including abnormal laboratory tests, ECG parameters and vital signs from screening through end of safety follow-up.
Measured: up to approximately 3 years after the first enrollment
Objective Response Rate (ORR) assessed per RECIST v1.1
ORR per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessed by investigator was defined as the percentage of participants with at least one visit confirmed complete response (CR) or partial response (PR), for all cohorts in Phase Ib and Cohort 1 of Phase II expansion stage.
Measured: up to approximately 3 years after the first enrollment
Progression-Free Survival (PFS) assessed per RECIST v1.1
PFS per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessed by investigator was defined as the time from the date of randomization or first study treatment until the date of confirmed progressive disease (PD), or death by any cause in the absence of progression, regardless of whether the participant withdrew from study therapy or received another anticancer therapy prior to progression, for Cohort 2 of Phase II expansion stage.
Measured: up to approximately 3 years after the first enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Aug 202630 Aug 2029

First posted6 Aug 2026
Study start30 Aug 2026 (estimated)
Primary completion31 Dec 2027 (estimated)
Study completion30 Aug 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Unresectable Advanced or Metastatic Colorectal CancerStudies of the same condition, open and under way.
More trials run by CSPC Megalith Biopharmaceutical Co.,Ltd.The 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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 260 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07750041
Sponsor's protocol ID: SYS6090-008
Status last verified: Jul 2026
First submitted: 2 Aug 2026
Last updated: 6 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Clinical Trials Information Group officer

0311-69085587

ctr-contact@cspc.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ib/II Study to Evaluate the Safety, Tolerability, and Efficacy of SYS6090 in Combination With Other Therapies in Participants With Advanced Coloretal Cancer
ClinicalTrials.gov ID: NCT07750041
Acronym / sponsor ID: SYS6090-008
Conditions: Unresectable Advanced or Metastatic Colorectal Cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 260 participants (estimated)
Lead sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.Industry (pharma, biotech, devices)
Study start: 30 Aug 2026 (estimated)
Primary completion: 31 Dec 2027 (estimated)
Study completion: 30 Aug 2029 (estimated)
First posted: 6 Aug 2026 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 7

Arm	Type	Receives
Ib-Randomized Arm 1	Experimental	Drug: SYS6090 (Fixed Dose Level A) + bevacizumabEnrolled Subjects will be randomized to receive SYS6090 at the fixed dose level A in combination with bevacizumab. The exact dose magnitude and administration frequency of SYS6090 are temporarily undisclosed to protect pending patent information, with full dosing details archived in platform backend for regulatory review only.
Ib-Randomized Arm 2	Experimental	Drug: SYS6090 (Fixed Dose Level B ) + bevacizumabEnrolled Subjects will be randomized to receive SYS6090 at the fixed dose level B in combination with bevacizumab. The exact dose magnitude and administration frequency of SYS6090 are temporarily undisclosed to protect pending patent information, with full dosing details archived in platform backend for regulatory review only.
II-Cohort 1- Randomized Arm A	Experimental	Drug: SYS6090 RP2D + bevacizumab +mFOLFOX6Enrolled Subjects will be randomized to receive SYS6090 at RP2D combined with bevacizumab and mFOLFOX6
II-Cohort 1- Randomized Arm B	Experimental	Drug: SYS6090 RP2D + bevacizumabEnrolled Subjects will be randomized to receive SYS6090 at RP2D combined with bevacizumab
II-Cohort 1- Randomized Arm C	Experimental	Drug: RegorafenibEnrolled Subjects will be randomized to receive regorafenib
II-Cohort 2- Randomized Arm D	Experimental	Drug: SYS6090 PR2D+ bevacizumab + FOLFOXIRIEnrolled Subjects will be randomized to receive SYS6090 at RP2D combined with bevacizumab and FOLFOXIRI
II-Cohort 2- Randomized Arm E	Active comparator	Drug: bevacizumab + FOLFOXIRIEnrolled Subjects will be randomized to receive bevacizumab combined with FOLFOXIRI

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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:
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.
At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.
Eastern Cooperative Oncology Group performance status of 0 or 1.

Key exclusion criteria (7 listed)

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;

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
SYS6090 (Fixed Dose Level A) + bevacizumabParticipants will receive intravenous SYS6090 at fixed dose level A combined with intravenous bevacizumab, administered per cycle schedule specified in study protocol, for advanced/palliative unresectable pMMR/MSS colorectal cancer.	Drug	Ib-Randomized Arm 1
SYS6090 (Fixed Dose Level B ) + bevacizumabParticipants will receive intravenous SYS6090 at fixed dose level B plus intravenous bevacizumab per protocol-defined cycle schedule for unresectable advanced pMMR/MSS colorectal cancer.	Drug	Ib-Randomized Arm 2
SYS6090 RP2D + bevacizumab +mFOLFOX6Participants will receive intravenous SYS6090 at RP2D plus intravenous bevacizumab combined with standard mFOLFOX6 chemotherapy regimen (oxaliplatin, leucovorin, fluorouracil), administered per protocol-defined cycle schedule for unresectable advanced pMMR/MSS colorectal cancer.	Drug	II-Cohort 1- Randomized Arm A
SYS6090 RP2D + bevacizumabParticipants will receive intravenous SYS6090 at RP2D plus intravenous bevacizumab, administered per protocol-defined cycle schedule for unresectable advanced pMMR/MSS colorectal cancer.	Drug	II-Cohort 1- Randomized Arm B
RegorafenibOral regorafenib monotherapy as standard control for metastatic pMMR/MSS colorectal cancer.	Drug	II-Cohort 1- Randomized Arm C
SYS6090 PR2D+ bevacizumab + FOLFOXIRIParticipants will receive intravenous SYS6090at RP2D plus intravenous bevacizumab combined with FOLFOXIRI triple chemotherapy (oxaliplatin, irinotecan, leucovorin, fluorouracil) per study cycle schedule for metastatic pMMR/MSS colorectal cancer.	Drug	II-Cohort 2- Randomized Arm D
bevacizumab + FOLFOXIRIParticipants will receive intravenous bevacizumab combined with FOLFOXIRI triple chemotherapy (oxaliplatin, irinotecan, leucovorin, fluorouracil) per study cycle schedule for metastatic pMMR/MSS colorectal cancer.	Drug	II-Cohort 2- Randomized Arm E

Primary outcome

Recommended Phase 2 Dose (RP2D), Safety and Tolerability
Time frame: up to approximately 3 years after the first enrollment
RP2D of SYS6090 combination therapy,Safety and tolerability are evaluated via incidence and severity of all Adverse Events (AEs) and Serious Adverse Events (SAEs) graded per NCI-CTCAE version 6.0, including abnormal laboratory tests, ECG parameters and vital signs from screening through end of safety follow-up.
Objective Response Rate (ORR) assessed per RECIST v1.1
Time frame: up to approximately 3 years after the first enrollment
ORR per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessed by investigator was defined as the percentage of participants with at least one visit confirmed complete response (CR) or partial response (PR), for all cohorts in Phase Ib and Cohort 1 of Phase II expansion stage.
Progression-Free Survival (PFS) assessed per RECIST v1.1
Time frame: up to approximately 3 years after the first enrollment
PFS per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessed by investigator was defined as the time from the date of randomization or first study treatment until the date of confirmed progressive disease (PD), or death by any cause in the absence of progression, regardless of whether the participant withdrew from study therapy or received another anticancer therapy prior to progression, for Cohort 2 of Phase II expansion stage.

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 6 Aug 2026.

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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.

Clinical Trials Information Group officer contact

0311-69085587

ctr-contact@cspc.cn

LIN contact

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 7 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: opening soon, as of the sponsor's last update on 6 Aug 2026. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Contact Clinical Trials Information Group officer (0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended Phase 2 Dose (RP2D), Safety and Tolerability (time frame: up to approximately 3 years after the first enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07750041.

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 6 Aug 2026.