The study is being conducted to evaluate the efficacy and safety of JSKN003 Versus Physician Choiced Treatment in Patients With HER2-positive and Advanced Colorectal Cancer Who had Failed to Respond to Oxaliplatin, 5-Fu, and Irinotecan subjects.
Age≥18 years old.
Unresectable locally advanced or distant metastatic BRAFV600E wild-type colorectal cancer diagnosed histologically or cytologically.
After treatment with oxaliplatin, 5-fluorouracil (such as 5-FU, Capecitabine) , irinotecan (DMMR/MSI-H subjects also need anti-PD-1/PD-L1 antibody treatment failure).
HER2-positive (defined as IHC3+ or IHC 2+/FISH +).
Participants who have previously been treated with an anti-HER2 ADC loaded with topoisomerase I inhibitors.
Participants with brain metastasis or spinal cord compression at screening.
Previous antineoplastic therapy toxicities did not revert to a CTCAE v5.0 grade rating of ≤1.
There are obvious clinical manifestations of gastrointestinal abnormalities, including but not limited to: having experienced intestinal obstruction or symptoms and signs of intestinal obstruction within 3 months prior to administration; having had gastrointestinal perforation, gastrointestinal fistula, or intra-abdominal abscess within 3 months prior to administration; having experienced gastrointestinal bleeding of CTCAE grade ≥ 3 within 3 months prior to administration, or having had gastrointestinal bleeding within the previous 1 month.
Parallel
JSKN003
DrugJSKN003 (6.3 mg/kg) was administered intravenously on the first day of each cycle, once every 3 weeks (Q3W).
Physician choiced treatment, include: TAS-102, Regorafenib, Fruquintinib.
DrugTAS-102(35 mg/m2, maximum 80 mg per dose), twice daily (BID), once every 4 weeks (Q4W); or Regorafenib 160mg, once daily (QD), once every 4 weeks (Q4W); or Fruquintinib 5mg once daily (QD), once every 4 weeks (Q4W).
Progressive Free Survive (PFS) assessed by Independent Review Committee
Progressive Free Survive (PFS) assessed by the Investigator
Objective response rate (ORR) assessed by the Investigator or IRC
Duration of Response (DOR) assessed by the Investigator or IRC
Overall Survival (OS)
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This trial is not recruiting at the moment. You can still explore other options:
