ClinicalTrials.gg
Not yet recruitingNCT07750041Updated Aug 6, 2026

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

A Phase 1/2 interventional study of SYS6090 (Fixed Dose Level A) + bevacizumab and SYS6090 (Fixed Dose Level B ) + bevacizumab in Unresectable Advanced or Metastatic Colorectal Cancer, sponsored by CSPC Megalith Biopharmaceutical Co.,Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-06.

Sponsored by CSPC Megalith Biopharmaceutical Co.,Ltd. (part of CSPC Pharmaceutical Group Limited) · Phase 1/2, Interventional, and Treatment

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Phase
Phase 1/2
Study type
Interventional
Enrollment
260
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 230 studies testing bevacizumab in Colorectal Neoplasms — 49 open to participants now, 61 under way, 11 of them phase 3. Bevacizumab · Colorectal Neoplasms.

Planned enrollment
42nd of 224
260 · median 63
Started
2026
with 12 others
Phase 1/2
11 of 230
5 open now
Primary completion
2027-12
later than 43 of 60 live
Registered
230th of 230
by date

Among the 230 studies testing bevacizumab in Colorectal Neoplasms, this one is the 42nd largest by planned enrollment of the 224 interventional ones that give a count, is one of 13 that started in 2026, is one of 11 in phase 1/2, reaches primary completion later than 43 of the 60 other live ones, and was the 230th registered.

Colorectal Neoplasms

6,545 studies on the registry are indexed under Colorectal Neoplasms; 1,664 are open to participants now.

Browse Colorectal Neoplasms studies →

Open to participants now

49 of the 230 studies testing bevacizumab in Colorectal Neoplasms are open now, in 12 countries. Recruiting first, the newest first:

44 more — sign in →

By country, each count listing its studies:

All 49 open studies →

About bevacizumab

Bevacizumab: first FDA approval 2004 (AVASTIN), first EMA approval 2005. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 1,181 Colorectal Neoplasms studies recruiting now, 764 (65%) set no upper age limit and 264 (22%) stop at 75 or younger; 48 take children under 18; 123 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 230 studies testing bevacizumab in Colorectal Neoplasms, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Unresectable Advanced or Metastatic Colorectal Cancer
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

*Eligibility Criteria:

Inclusion criteria

Inclusion Criteria:

  1. Subjects must be ≥18 years of age.
  2. or cytologically confirmed unresectable advanced or 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 at baseline according to 1.1 criteria.
  4. performance status of 0 or 1.
  5. Expected survival ≥ 3 months.
  6. Has protocol-defined adequate organ and bone marrow function.

Exclusion criteria

Exclusion Criteria:

  1. Subjects with clinically active central nervous system ;
  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 , 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 .
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
260 participants (estimated)

Study arms

  • Experimental
    Ib-Randomized Arm 1

    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.

    Drug: SYS6090 (Fixed Dose Level A) + bevacizumab

  • Experimental
    Ib-Randomized Arm 2

    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.

    Drug: SYS6090 (Fixed Dose Level B ) + bevacizumab

  • Experimental
    II-Cohort 1- Randomized Arm A

    Enrolled Subjects will be randomized to receive SYS6090 at RP2D combined with bevacizumab and mFOLFOX6

    Drug: SYS6090 RP2D + bevacizumab +mFOLFOX6

  • Experimental
    II-Cohort 1- Randomized Arm B

    Enrolled Subjects will be randomized to receive SYS6090 at RP2D combined with bevacizumab

    Drug: SYS6090 RP2D + bevacizumab

  • Experimental
    II-Cohort 1- Randomized Arm C

    Enrolled Subjects will be randomized to receive regorafenib

    Drug: Regorafenib

  • Experimental
    II-Cohort 2- Randomized Arm D

    Enrolled Subjects will be randomized to receive SYS6090 at RP2D combined with bevacizumab and FOLFOXIRI

    Drug: SYS6090 PR2D+ bevacizumab + FOLFOXIRI

  • Active comparator
    II-Cohort 2- Randomized Arm E

    Enrolled Subjects will be randomized to receive bevacizumab combined with FOLFOXIRI

    Drug: bevacizumab + FOLFOXIRI

Interventions

  • DrugSYS6090 (Fixed Dose Level A) + bevacizumab

    Drug pages: Anti-PD-1/IL-15 Fusion Protein JMT108 · Bevacizumab

    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.

  • DrugSYS6090 (Fixed Dose Level B ) + bevacizumab

    Drug pages: Anti-PD-1/IL-15 Fusion Protein JMT108 · Bevacizumab

    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.

  • DrugSYS6090 RP2D + bevacizumab +mFOLFOX6

    Drug pages: Anti-PD-1/IL-15 Fusion Protein JMT108 · Bevacizumab

    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.

  • DrugSYS6090 RP2D + bevacizumab

    Drug pages: Anti-PD-1/IL-15 Fusion Protein JMT108 · Bevacizumab

    Participants will receive intravenous SYS6090 at RP2D plus intravenous bevacizumab, administered per protocol-defined cycle schedule for unresectable advanced pMMR/MSS colorectal cancer.

  • Oral regorafenib monotherapy as standard control for metastatic pMMR/MSS colorectal cancer.

  • DrugSYS6090 PR2D+ bevacizumab + FOLFOXIRI

    Drug pages: Anti-PD-1/IL-15 Fusion Protein JMT108 · Bevacizumab

    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.

  • Drugbevacizumab + FOLFOXIRI

    Drug page: Bevacizumab

    Participants will receive intravenous bevacizumab combined with FOLFOXIRI triple chemotherapy (oxaliplatin, irinotecan, leucovorin, fluorouracil) per study cycle schedule for metastatic pMMR/MSS colorectal cancer.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to approximately 3 years after the first enrollment

  2. 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.

    Time frame: up to approximately 3 years after the first enrollment

  3. 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.

    Time frame: up to approximately 3 years after the first enrollment

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Dec 2027, 16 months later.

Of 158 industry-sponsored phase 1/2 interventional studies under Colorectal Neoplasms, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 82. This study's planned 16 months is below that.

Counting every sponsor, half of 260 studies reached it within 59 months; a quarter within 36 and three quarters within 87.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 2, 2026
First posted
Aug 6, 2026
StartEst.
Aug 30, 2026
Primary completionEst.
Dec 31, 2027
CompletionEst.
Aug 30, 2029
Last update
Aug 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07750041
Responsible party
Sponsor
First posted
Aug 6, 2026
Start date
Aug 30, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Aug 30, 2029 (estimated)
Last update
Aug 6, 2026

Study contacts

Clinical Trials Information Group officer
Contact
ctr-contact@cspc.cn
0311-69085587
LIN
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drugs tested here: Anti-PD-1/IL-15 Fusion Protein JMT108 · Bevacizumab · Regorafenib

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