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

NCT07750041 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2026-08-06

No results posted yet for this 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.

Conditions

  • Unresectable Advanced or Metastatic Colorectal Cancer

Interventions

DRUG

SYS6090 (Fixed Dose Level B ) + 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.

DRUG

SYS6090 (Fixed Dose Level A) + 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.

DRUG

SYS6090 RP2D + bevacizumab +mFOLFOX6

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.

DRUG

SYS6090 RP2D + bevacizumab

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

DRUG

Regorafenib

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

DRUG

SYS6090 PR2D+ bevacizumab + FOLFOXIRI

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.

DRUG

bevacizumab + FOLFOXIRI

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

Sponsors & Collaborators

  • CSPC Megalith Biopharmaceutical Co.,Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-30
Primary Completion
2027-12-31
Completion
2029-08-30

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07750041 on ClinicalTrials.gov