A Study of SI-B001, an EGFR/HER3 Bispecific Antibody, in Locally Advanced or Metastatic Epithelial Tumors

Guangzhou, China

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

No Placebo-Only Group

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.

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Eligible Conditions

Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 24 months

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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