MedTrace Logo

A Study of SI-B003, a PD-1/CTLA-4 Bispecific Antibody, in Patients With Advanced Solid Tumors

NCT04606472 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-09-26

No results posted yet for this study

Summary

In phase Ia study, the safety and tolerability of SI-B003 in patients with recurrent or metastatic solid tumors will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) or maximum administered dose (MAD) for MTD is not reached of SI-B003.

In the phase Ib study, the safety and tolerability of SI-B003 in specific tumors will be further investigated by selecting multiple doses based on the results of phase Ia study or/and the fixed-dose administration method with the closest exposure level, and recommended phase II dose (RP2D) for phase II clinical studies will be determined.

Conditions

Interventions

DRUG

SI-B003

Administration by intravenous infusion.

Sponsors & Collaborators

  • SystImmune Inc.

    collaborator INDUSTRY

  • Sichuan Baili Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Lin Shen · Peking University Cancer Hospital & Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-10
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT04606472 on ClinicalTrials.gov