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NCT07793994Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 31 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
130 (estimated)
First submitted
21 Aug 2026
Start date
Sept 2026
Primary completion date
31 Mar 2029
Lead sponsor
Dana-Farber Cancer Institute
NCT number
NCT07793994

What you commit to

  • Study type: Interventional
  • Planned participants: 130
  • From Sept 2026 to the primary completion date, 31 Mar 2029
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • adults who are unable to consent
  • pregnant women
  • incarcerated individuals

Who the study is looking for

  • Age 0 - 30 years at time of initial diagnosis of the solid or CNS tumor
  • Diagnosis of relapsed or refractory solid or CNS tumor, without a limit on the number of prior episodes of relapse. Refractory disease is defined as disease that progresses on standard-of-care upfront therapy or requires salvage therapy due to inadequate response, e.g. bridging chemoimmunotherapy in a patient with high-risk neuroblastoma and poor end-induction response (PEIR).
  • Life expectancy of at least 12 weeks at the time of enrollment
  • Available specimens Tissue block or unstained slides available expected to yield a minimum of 30 total slides., OR other specimens expected to result in adequate (1) RNA quantity and quality for sequencing and (2) IHC testing may substitute for tissue requirement above with the approval of the PI or study staff designee approval prior to submission enrollment. Tumor tissue from relapse/progression is preferred, but tumor tissue from diagnosis if obtained prior to neoadjuvant chemotherapy is acceptable if no relapse/progression sample available.Note that this requirement may be reduced to 15 total slides for patients who have already had RNA sequencing performed on their tumor material.
  • Informed consent for participation for adult participants or parental permission for minor participants (with assent as appropriate based on age of participant).
  • Age 0 - 30 years at time of initial diagnosis of the solid or CNS tumor
  • Diagnosis of relapsed or refractory solid or CNS tumor, without a limit on the number of prior episodes of relapse. Refractory disease is defined as disease that progresses on standard-of-care upfront therapy or requires salvage therapy due to inadequate response, e.g. bridging chemoimmunotherapy in a patient with high-risk neuroblastoma and poor end-induction response (PEIR).
  • Available specimens Tissue block or unstained slides available expected to yield a minimum of 15 total slides OR other specimens expected to result in adequate IHC testing may substitute for tissue above with the approval of the PI or study staff approval designee prior to submission.. Tumor tissue from relapse/progression is preferred, but tumor tissue from diagnosis if obtained prior to neoadjuvant chemotherapy is acceptable if no relapse/progression sample available.
  • Prior receipt of an antibody-drug conjugate (ADC). The ADC may have been received via either commercial supply or as a participant on a clinical trial. The ADC may have been received at any time during a patient's treatment course for relapsed or refractory disease and on or after January 1st, 2011 up to the time of enrollment of the final prospective participant.

Age in the registry: - to 30 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Dana-Farber Cancer Institute
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
Boston Children's Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.