WP1066 in Children With Refractory and Progressive or Recurrent Malignant Brain Tumors

Phase 1

Waitlist Available

Led By Tobey MacDonald, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 months post-intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing WP1066, a new drug, to help children with brain tumors that don't respond to other treatments. WP1066 works by blocking a pathway that helps cancer cells grow and hide from the immune system.

Eligible Conditions

Medulloblastoma
Brain Tumor

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 months post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 months post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 months post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in safety and tolerability of WP1066: Maximum tolerated dose (MTD) and Dose limiting toxicities (DLT)

Maximum tolerated dose (MTD) of WP1066

Secondary study objectives

Change in Immunological response

Change in overall response rate (ORR) of WP1066 treatment

Change in overall survival (OS)

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: WP1066Experimental Treatment1 Intervention

There will be 5 groups based on the enrollment timing. The first group of participants will receive the lowest dose level of WP1066. Each subject within a group will receive an assigned dose of the investigational drug. The dose levels are 4, 6, 8 and 16 mg/kg of the investigational drug given twice a day. The first group will receive the lowest dose level, 4mg/kg twice a day, and subsequent groups will escalate to the next higher dose level. All groups will be treated identically, except for the dose of drug administered, with the liquid formulation of the drug.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

WP1066

2020

Completed Phase 1

~10

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