NCT05039944

SI-B001 as a Single Agent or in Combination With Chemotherapy in the Treatment of Digestive System Malignancies

A Phase II Clinical Study to Evaluate the Efficacy and Safety of SI-B001 as a Single Agent or in Combination With Chemotherapy in the Treatment of Unresectable or Metastatic Digestive System Malignancies (Colorectal and Gastric Cancer)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multi-center, open label Phase II clinical study is performed in patients with unresectable or metastatic malignant tumors of the digestive system (colorectal cancer, gastric cancer). This study is investigating the safety and efficacy of SI-B001 at monotherapy or optimal combination dose with chemotherapy in patients.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	SI-B001	In Arm\_A, B and C, the intravenous infusion dose of SI-B001 was single drug RP2D selected in phase I (Q2W); In Cohort\_D, E, and F, SI-B001 was divided into two doses, the high dose was the single drug RP2D selected in phase I clinical trial, and the low dose was the second low dose of single drug RP2D, both of which were administered by intravenous infusion.
DRUG	Irinotecan	Administration by intravenous infusion, 180 mg/m2 Q2W.
DRUG	FOLFIRI Protocol	FOLFIRI is administered intravenously at the standard dose recommended by the guidelines(Q2W).
DRUG	FOLFOX Protocol	FOLFOX is administered intravenously at the standard dose recommended by the guidelines(Q2W).

Timeline

• Start date: 2021-11-30
• Primary completion: 2022-06-06
• Completion: 2022-06-06
• First posted: 2021-09-10
• Last updated: 2024-07-18

Locations

1 site across 1 country: China