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

Prior treatment

• 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;
• Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to Grade ≤ 1 or baseline .

Other illness

• with a history of other primary malignant tumors within 5 years before administration;
• Uncontrolled or significant cardiovascular disease;

Other

• Subjects with clinically active central nervous system metastases;
• Clinically uncontrolled pleural effusion, ascites or pericardial effusion;

• 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.

Criteria the registry did not label

• \*Eligibility Criteria: