A Phase Ib/II Study of SYS6090 Combination Therapy in Advanced Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SYS6090 (Fixed Dose Level A) + bevacizumab, SYS6090 (Fixed Dose Level B ) + bevacizumab, SYS6090 RP2D + bevacizumab +mFOLFOX6, SYS6090 RP2D + bevacizumab.
- Who it may be relevant to
- Registry conditions: Unresectable Advanced or Metastatic Colorectal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- 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 (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 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.
Primary outcome measures
- Recommended Phase 2 Dose (RP2D), Safety and Tolerability [Time frame: up to approximately 3 years after the first enrollment]
- Objective Response Rate (ORR) assessed per RECIST v1.1 [Time frame: up to approximately 3 years after the first enrollment]
- Progression-Free Survival (PFS) assessed per RECIST v1.1 [Time frame: up to approximately 3 years after the first enrollment]
Eligibility criteria
\*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 .
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fujian Cancer Hospital — Fujian
Identifiers
NCT: NCT07750041 · SYS6090-008