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Tyrosine Kinase Inhibitor

X4P-001 for Renal Cell Carcinoma

Phase 1 & 2
Waitlist Available
Research Sponsored by X4 Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 80 weeks, from time of enrollment through study completion or early termination
Awards & highlights

Study Summary

This trial will test the safety and effectiveness of a new drug, X4P-001, for treating advanced renal cell carcinoma.

Eligible Conditions
  • Renal Cell Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 80 weeks, from time of enrollment through study completion or early termination
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 80 weeks, from time of enrollment through study completion or early termination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)
Secondary outcome measures
Area Under the Curve (AUC)
Disease Control Rate
Maximum Plasma Concentration (Cmax)
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part CExperimental Treatment1 Intervention
X4P-001 monotherapy
Group II: Part BExperimental Treatment2 Interventions
Randomized assignment to one of two regimens: X4P-001 at the Part A maximum tolerated dose (MTD), in combination with axitinib X4P-001 at 0.5x Part A MTD, in combination with axitinib
Group III: Part AExperimental Treatment2 Interventions
X4P-001 + axitinib dose escalation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
X4P-001
2016
Completed Phase 2
~100
Axitinib
FDA approved

Find a Location

Who is running the clinical trial?

X4 PharmaceuticalsLead Sponsor
9 Previous Clinical Trials
288 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~8 spots leftby Apr 2025