Trial intelligence / Profile preview

SHR-4375 in advanced solid tumors

NCT06764628Phase 2

Key facts

Status: Recruiting
Start: Jan 2025
Primary completion: May 2027
Countries: 1
Sponsor: Suzhou Suncadia Biopharmaceutical
Modality: Biologic

Drugs: SHR-4375
Conditions: solid tumor

Overview

Phase 2, open-label, single-arm trial of SHR-4375 in solid tumor, sponsored by Suzhou Suncadia Biopharmaceutical. Primary endpoints: Adverse events (AEs), Dose limiting toxicity (DLT) and 2 more. Started Jan 2025; status: recruiting.

Design

1 arm

Study design: Non-randomizedOpen-label

Treatment group
SHR-4375 injection

Endpoints

Primary

Adverse events (AEs)Day 1 to 90 days after last dose
Dose limiting toxicity (DLT)Day 1 to 12 months
Maximal tolerable dose (MTD)Day 1 to 12 months
Recommended phase 2 dose (RP2D)Day 1 to 12 months

Secondary

Progression free survival (PFS)Day 1 to 12 months
Objective response rate (ORR)Day 1 to 12 months
Disease control rate (DCR)Day 1 to 12 months
Duration of response (DOR)Day 1 to 12 months
Overall survival (OS)Day 1 to 12 months

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