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

Sponsor
UNICANCER
Study ID
NCT07259226
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced Breast Cancer
  • Advanced Gastric Cancer
  • Advanced Non Small Cell Lung Cancer (NSCLC)
  • Advanced Urothelial Cancer

Eligibility Criteria

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

Interventions

  • Biological samples collection — PROCEDURE
    Biological samples collection (tumor tissue, blood, sputum) before initiation of treatment, during treatment, and at treatment discontinuation.
  • questionnaires to collect patient reported outcomes — BEHAVIORAL
    QLQ-C30, QLQ-FA12, HADS, EQ-5D 5L

Study Details

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.

Key Dates

First listed
Dec 2, 2025
Start date
Nov 14, 2025
Status verified
Aug 2025
Primary completion
Nov 1, 2030
Completion
Nov 1, 2030

Study Design

Enrollment
400 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Other: T-DXd (trastuzumab deruxtecan)
    Standard of care T-DXd indication
  • Other: T-DM1 (trastuzumab emtansine)
    Standard of care T-DM1 indication
  • Other: SG (sacituzumab govitecan)
    Standard of care SG indication
  • Other: EV (enfortumab vedotin)
    Standard of care EV indication

Primary Outcome Measure

Biomarkers of resistance to ADC [ Time Frame: Through study completion, an average of 3 years ]

Central Contacts

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