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. · Phase 1/2, Interventional, and Treatment
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.
*Eligibility Criteria:
Inclusion Criteria:
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.
Exclusion Criteria:
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
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
Enrolled Subjects will be randomized to receive SYS6090 at RP2D combined with bevacizumab and mFOLFOX6
Drug: SYS6090 RP2D + bevacizumab +mFOLFOX6
Enrolled Subjects will be randomized to receive SYS6090 at RP2D combined with bevacizumab
Drug: SYS6090 RP2D + bevacizumab
Enrolled Subjects will be randomized to receive regorafenib
Drug: Regorafenib
Enrolled Subjects will be randomized to receive SYS6090 at RP2D combined with bevacizumab and FOLFOXIRI
Drug: SYS6090 PR2D+ bevacizumab + FOLFOXIRI
Enrolled Subjects will be randomized to receive bevacizumab combined with FOLFOXIRI
Drug: bevacizumab + FOLFOXIRI
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.
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.
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.
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.
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.
Participants will receive intravenous bevacizumab combined with FOLFOXIRI triple chemotherapy (oxaliplatin, irinotecan, leucovorin, fluorouracil) per study cycle schedule for metastatic pMMR/MSS colorectal cancer.
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
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
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
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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CSPC Megalith Biopharmaceutical Co.,Ltd.