MedTrace Logo

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

NCT05103917 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-11-02

No results posted yet for this study

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

Conditions

Interventions

DRUG

X4P-001

CXCR4 inhibitor

Sponsors & Collaborators

  • Abbisko Therapeutics Co, Ltd

    lead INDUSTRY

Principal Investigators

  • J L Zheng, Director · Abbisko Therapeutics Co, Ltd

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-21
Primary Completion
2022-11-24
Completion
2023-05-21

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 NCT05103917 on ClinicalTrials.gov