NCT05928780

An Umbrella Trial Based on Molecular Pathway for Patients With Metastatic TNBC in First-line Treatment (FUTURE-Trop2)

A Molecular Pathway-based Umbrella Trial for First-line Precision Therapy With TROP2 in Patients With Locally Advanced or Metastatic TNBC (Future-Trop2 Study)

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To explore the efficacy and safety of TROP2 in the treatment of ABC

Detailed description

To explore the efficacy and safety of advanced first-line TROP2 precision therapy in patients with locally advanced or metastatic triple-negative breast cancer based on molecular subtypes

Conditions

• TNBC - Triple-Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	A1:SG with SHR3680	SG 10mg/kg d1, 8；SHR3680 240mg qd，3 weeks is a cycle
DRUG	A2:SG	SG 10mg/kg d1, 8
DRUG	B1:SG with SHR1210	SG 10mg/kg， d1, 8；SHR1210 200mg，d1，q3w；
DRUG	B2:SG	SG 10mg/kg， d1, 8
DRUG	C1:SG with SHR3162	SG 10mg/kg d1, 8；SHR3162，150mg，QD ，3 weeks is a cycle
DRUG	C2:SG	SG 10mg/kg d1, 8
DRUG	D1:SG with VEGFRI	SG 10mg/kg，d1, 8；BP102 15mg/kg，d1，3 weeks is a cycle
DRUG	D2:SG	SG 10mg/kg d1, 8

Timeline

• Start date: 2023-07-01
• Primary completion: 2024-03-01
• Completion: 2025-09-01
• First posted: 2023-07-03
• Last updated: 2023-07-03