Optimal Methods to Characterize ADC Resistance in Solid Tumors and Identify Clinically Useful Biomarkers

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUNICANCER

About this trial

International study that will evaluate the association of prespecified biomarkers with resistance to Antibody-drug conjugates (ADCs), a type of targeted cancer treatment currently used in clinical practice for treating different tumor types.

Eligibility criteria

Qualifiers

Patients must have signed a written informed consent form prior to any trial specific procedures;

Patients must be ≥18 years old;

Histologically confirmed or radiologically documented unresectable locally advanced or metastatic cancer (Breast, Urothelial, Non small Cell Lung or Gastric) with an indication to receive an Antibody-Drug Conjugate (ADC) approved or accessible through an early access program;

Patients must have at least 2 tumor lesions (primary tumor can be included): at least one measurable tumor lesion for tumor evaluation according to response evaluation criteria in solid tumors (RECIST) V1.1 and at least one tumor lesion other than bone and brain for biopsy;

Disqualifiers

Patients treated with an antibody drug conjugate in a curative setting;

Patients who did not consent to sample use;

Presence of another progressive pathology with short-term life-threatening prognosis;

Patients undergoing concurrent treatment for a malignancy or hematologic disorder distinct from the indication for which the ADC is being administered.

Trial design

Treatments tested in this trial

  • Biological samples collection
  • questionnaires to collect patient reported outcomes

Treatment groups

400 Participants
are divided into 4 treatment groups

Sponsors and collaborators