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Kinase Inhibitor

XRD-0394 + Palliative Radiotherapy for Advanced Cancer

Phase 1
Waitlist Available
Research Sponsored by XRad Therapeutics Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
One or more of the following sites of metastasis: Skin, Subcutaneous or soft tissue, Any other site that will allow the radiation dose to normal structures to remain within protocol-specified dosing limits.
Other protocol-defined criteria may apply
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days post-completion of rt
Awards & highlights

Study Summary

This trial is testing a new cancer drug that inhibits two enzymes, ATM and DNA-PK. It is the first time this drug is being used in humans. The trial will evaluate the safety and tolerability of single doses of the drug, as well as its effects when combined with palliative radiotherapy.

Eligible Conditions
  • Metastasis
  • Solid Tumors
  • Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
The cancer has spread to the skin, soft tissues, or other sites where radiation treatment can be given without harming nearby healthy tissues.
Select...
There may be additional requirements specific to the study that you need to meet.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days post-completion of rt
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days post-completion of rt for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of subjects experiencing treatment-emergent adverse events (TEAE), serious TEAEs, TEAEs leading to discontinuation of RT, and TEAEs leading to death
Number of subjects with at least 1 dose-limiting toxicity (DLT)
Secondary outcome measures
Change in radiation-induced phosphorylated Krüppel-associated box domain (KRAB)-associated protein 1 (pKAP1) in tumor biopsy samples
Determination of area under the plasma concentration versus time curve from zero to infinity (AUC0-∞) after a single dose of XRD-0394
Determination of area under the plasma concentration versus time curve from zero to the last sampling time (AUC0-t) after a single dose of XRD-0394
+5 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: XRD-0394 80 mgExperimental Treatment2 Interventions
Subjects will receive a single dose of XRD-0394 capsules approximately 90 minutes before RT on Day 2 of the RT regimen
Group II: XRD-0394 40 mgExperimental Treatment2 Interventions
Subjects will receive a single dose of XRD-0394 capsules approximately 90 minutes before RT on Day 2 of the RT regimen
Group III: XRD-0394 160 mgExperimental Treatment2 Interventions
Subjects will receive a single dose of XRD-0394 capsules approximately 90 minutes before RT on Day 2 of the RT regimen
Group IV: XRD-0394 (Dose TBD)Experimental Treatment2 Interventions
Subjects will receive a single dose of XRD-0394 capsules approximately 90 minutes before RT. A single biopsy will be performed in each subject (either after RT alone or after XRD-0394 and RT).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
XRD-0394
2021
Completed Phase 1
~20
Palliative radiotherapy
2015
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

XRad Therapeutics IncLead Sponsor

Media Library

XRD-0394 (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05002140 — Phase 1
Metastasis Research Study Groups: XRD-0394 40 mg, XRD-0394 80 mg, XRD-0394 160 mg, XRD-0394 (Dose TBD)
Metastasis Clinical Trial 2023: XRD-0394 Highlights & Side Effects. Trial Name: NCT05002140 — Phase 1
XRD-0394 (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05002140 — Phase 1

Frequently Asked Questions

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~3 spots leftby Mar 2025