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Pedi-STAR: Surface Target Antibody-drug Conjugate (ADC) Antigen Expression in Relapsed/Refractory Pediatric Solid and CNS Tumors

NCT07793994 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-08-31

No results posted yet for this study

Summary

This study is looking to learn whether a tumor testing approach can feasibly measure antibody-drug conjugate (ADC) target proteins in children and young adults with relapsed or refractory solid tumors or central nervous system (CNS) tumors.

The tumor testing approach is a two-step tumor profiling process of:

* Screening with bulk RNA sequencing to see which ADC target genes are turned on in the tumor.
* Confirmatory immunohistochemistry (IHC) for targets that show positive expression on the RNA screen, to confirm protein expression.

Conditions

  • CNS Tumor
  • Solid Tumor
  • Relapsed Cancer
  • Refractory Cancer
  • Pediatric Cancer

Interventions

DIAGNOSTIC_TEST

Bulk RNA Sequencing

Test performed on tumor tissue to measure antibody-drug conjugate (ADC) target expression

DIAGNOSTIC_TEST

Immunohistochemistry (IHC)

Test performed on tumor tissue to confirm protein expression of antibody-drug conjugate (ADC) target antigens identified by bulk RNA sequencing

Sponsors & Collaborators

Principal Investigators

  • Steven Dubois, MD,MS · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2029-03-31
Completion
2030-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT07793994 on ClinicalTrials.gov