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Monoclonal Antibodies

Study treatment for Cancer

Phase 1
Recruiting
Led By Li Zhang
Research Sponsored by Sichuan Baili Pharmaceutical Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 24 months
Awards & highlights

Summary

In phase Ia study, the safety and tolerability of SI-B001 in patients with locally advanced or metastatic epithelial malignancies will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of SI-B001. In the phase Ib study, the safety and tolerability of SI-B001 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined. In addition, the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of SI-B001 in patients with locally advanced or metastatic epithelial tumors will be evaluated.

Eligible Conditions
  • Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase Ia: Dose limiting toxicity (DLT)
Phase Ia: Maximum tolerated dose (MTD)
Phase Ib: Recommended Phase II Dose (RP2D)
Secondary study objectives
ADA (anti-drug antibody)
AUC0-t
CL (Clearance)
+11 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Study treatmentExperimental Treatment1 Intervention
Participants receive SI-B001 as intravenous infusion for the first cycle (4 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Find a Location

Who is running the clinical trial?

Sichuan Baili Pharmaceutical Co., Ltd.Lead Sponsor
70 Previous Clinical Trials
10,364 Total Patients Enrolled
SystImmune Inc.Industry Sponsor
20 Previous Clinical Trials
1,472 Total Patients Enrolled
Li ZhangPrincipal InvestigatorSun Yat-sen University
19 Previous Clinical Trials
10,676 Total Patients Enrolled
~11 spots leftby Sep 2025
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