NCT05103917

A Study to Assess the Safety, Tolerability and Antitumor Activity of X4P-001 in Combination With TNBC

An Open Label, Phase Ib/II Trial to Study the Safety, Tolerability and Antitumor Activity of X4P-001 in Combination With Toripalimab in Patients With Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Abbisko Therapeutics Co, Ltd · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Objectives Phase 1b Primary Objectives: To evaluate the safety and tolerability of X4P-001 combined with toriplimab in patients with locally advanced or metastatic TNBC Secondary Objectives: 1. To characterize the pharmacokinetics (PK) profile of X4P-001 alone or combined with toriplimab 2. To characterize the antitumor activity of X4P-001 in combination with toriplimab in patients with locally advanced or metastatic TNBC(according to RECIST 1.1) 3. To characterize the overall survival of X4P-001 in combination with toriplimab in patients with locally advanced or metastatic TNBC 4. To characterize the immunogenicity of toriplimab when administrated in combination with X4P-001

Detailed description

Exploratory Objectives: 1. To explore selected biomarkers in peripheral blood and tumor samples that potentially correlate with clinical response to X4P-001 and toriplimab combination treatment 2. To characterize the antitumor activity of X4P-001 in combination with toriplimab in patients with locally advanced or metastatic TNBC(according to iRECIST 1.1)

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	X4P-001	CXCR4 inhibitor

Timeline

• Start date: 2021-07-21
• Primary completion: 2022-11-24
• Completion: 2023-05-21
• First posted: 2021-11-02
• Last updated: 2021-11-02

Locations

1 site across 1 country: China