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

NCT05039944 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2024-07-18

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Sichuan Baili Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Weijian Guo · Fudan University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2022-06-06
Completion
2022-06-06

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05039944 on ClinicalTrials.gov