A Phase Ib/III Study of Suvemcitug Plus FTD/TPI in Participants With Refractory Metastatic Colorectal Cancer

The primary goal of Phase Ib Study is to evaluate the safety of Suvemcitug in combination with trifluridine/tipiracil tablets in colorectal cancer participants. The primary goal of Phase III Study is to evaluate the efficacy of Suvemcitug in combination with trifluridine/tipiracil tablets in colorectal cancer participants. Researchers will compare Suvemcitug + trifluridine/tipiracil tablets with placebo (a look-alike substance that contains no drug)+ trifluridine/tipiracil tablets to see if Suvemcitug + trifluridine/tipiracil tablets works better in treating refractory metastatic colorectal c

Trial Details

NCT ID
NCT07361003
Phase
PHASE3
Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Suvemcitug injection, trifluridine/tipiracil tablets
  • Suvemcitug placebo injection, trifluridine/tipiracil tablets
Locations (sample)
  • Fuzhou, Fujian, China|26.06139,119.30611
  • Harbin, Heilongjiang, China|45.75,126.65
  • Nanjing, Jiangsu, China|32.06167,118.77778
  • Jinan, Shandong, China|36.66833,116.99722
  • Tianjin, Tianjin Municipality, China|39.14222,117.17667

Key Eligibility Criteria

  • 1\. Confirmed by histological and/or cytological examination as unresectable metastatic colon or rectal adenocarcinoma;
  • 2\. At least one measurable tumor lesion (RECIST v1.1);
  • 3\. Previously received fluorouracil, oxaliplatin, and irinotecan based chemotherapy; had previously undergone or was unsuitable for anti-VEGF ther…
  • 4\. Refractory metastatic colorectal cancer having progressed on or are intolerant to the last systemic treatment;

For full eligibility, visit ClinicalTrials.gov.

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