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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT07793994
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Bulk RNA Sequencing — DIAGNOSTIC_TEST
    Test performed on tumor tissue to measure antibody-drug conjugate (ADC) target expression
  • Immunohistochemistry (IHC) — DIAGNOSTIC_TEST
    Test performed on tumor tissue to confirm protein expression of antibody-drug conjugate (ADC) target antigens identified by bulk RNA sequencing

Study Details

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.

Key Dates

First listed
Aug 31, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Mar 31, 2029
Completion
Mar 31, 2030

Study Design

Enrollment
130 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Other: Prospective Cohort
    Participants with relapsed/refractory solid or CNS tumors will undergo eligibility screening, specimen submission, bulk RNA sequencing, and confirmatory IHC testing. IHC results will be returned to the enrolling provider
  • Other: Retrospective Cohort
    Participants who have received ADC therapy as part of routine clinical care will submit specimens for targeted IHC testing and clinical data collection. No RNA sequencing will be performed, and IHC results will not be returned

Primary Outcome Measure

Antibody-Drug Conjugate (ADC) Target Expression Screening Success Rate [Prospective Cohort] [ Time Frame: Week 6 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115
Steven DuBois, MD, MS
[email protected]
617-632-5460
Steven DuBois, MD, MS (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02115
Steven G. DuBois, MD, MS
[email protected]
617-632-5460
Steven G. DuBois, MD, MS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Boston Children's Hospital· Boston, MADana Farber Cancer Institute· Boston, MA

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