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NCT Number: NCT07750041

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

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.

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Key information

Conditions

Unresectable Advanced or Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

*Eligibility Criteria:

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:

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.

Exclusion criteria

  • 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 .

Treatment and study plan

SYS6090 (Fixed Dose Level A) + bevacizumab

Drug

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 ) + bevacizumab

Drug

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 +mFOLFOX6

Drug

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 + bevacizumab

Drug

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

regorafenib

Drug

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

SYS6090 PR2D+ bevacizumab + FOLFOXIRI

Drug

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 + FOLFOXIRI

Drug

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Information Group officer

CONTACT

[email protected]

0311-69085587

LIN

CONTACT

Sponsors and collaborators

Lead sponsor

CSPC Megalith Biopharmaceutical Co.,Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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