A Phase Ib/II Study of SYS6090 Combination Therapy in Advanced Colorectal Cancer
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCSPC Megalith Biopharmaceutical Co.,Ltd.
About this trial
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
Qualifiers
Subjects must be ≥18 years of age.
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- SYS6090 (Fixed Dose Level A) + bevacizumab
- SYS6090 (Fixed Dose Level B ) + bevacizumab
- SYS6090 RP2D + bevacizumab +mFOLFOX6
- SYS6090 RP2D + bevacizumab
- Regorafenib
- SYS6090 PR2D+ bevacizumab + FOLFOXIRI
- bevacizumab + FOLFOXIRI
Treatment groups
260 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov