Actively Recruiting
International Multicenter Multicohort Open-label Phase II Trial to Identify Biomarkers Predicting Response and Resistance to Antibody-Drug Conjugates in Patients with Solid Tumors Treated by Standard Indications
Led by UNICANCER · Updated on 2025-12-02
400
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how specific biomarkers relate to resistance against Antibody-Drug Conjugates (ADCs), a targeted cancer treatment used for various solid tumors such as advanced breast, gastric, urothelial, and non-small cell lung cancers. This international Phase II trial aims to improve understanding of why some tumors resist ADCs and to identify biomarkers that predict response and toxicity, helping personalize treatment choices. The study also addresses the complex biology of ADCs and the impact of patient factors on treatment side effects to improve quality of life during therapy. Participants receive standard-of-care ADC treatments including trastuzumab deruxtecan (T-DXd), trastuzumab emtansine (T-DM1), sacituzumab govitecan (SG), or enfortumab vedotin (EV) according to current clinical indications. The trial includes both retrospective analysis of past patients and prospective enrollment, with collection of tumor tissue, blood, and other biological samples before, during, and after treatment. Patient-reported outcomes are collected via questionnaires. Advanced laboratory techniques and machine-learning models will be used to analyze biomarker data and develop a score predicting ADC efficacy and toxicity. Throughout an average of three years of follow-up, participants undergo regular assessments including biopsies, blood tests, and questionnaires to monitor tumor response, resistance biomarkers, and side effects. Researchers will evaluate multiple outcome measures such as biomarker changes over time, patient quality of life, and treatment costs. This comprehensive approach aims to provide new insights into ADC resistance and toxicity while supporting personalized cancer care. Participants are monitored closely to ensure safety and data are collected to inform future ADC use.
CONDITIONS
Brief Title
Optimal Methods to Characterize ADC Resistance in Solid Tumors and Identify Clinically Useful Biomarkers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before any trial procedures
- Age 18 years or older
- Histologically or radiologically confirmed unresectable locally advanced or metastatic breast, urothelial, non-small cell lung, or gastric cancer
- Indication to receive an approved or early access Antibody-Drug Conjugate (ADC)
- At least two tumor lesions: one measurable for RECIST v1.1 evaluation and one accessible for biopsy (excluding bone and brain)
- Metastatic or locally advanced tumor site accessible for biopsy and consent to pre- and post-treatment biopsies
- Life expectancy of at least 12 weeks
- ECOG performance status of 0 to 2
- Adequate hematologic and organ function compatible with ADC treatment
- Agreement to use adequate contraception during participation and for specified months after treatment
- Affiliation to a social security system or equivalent
- Willingness and ability to comply with the trial protocol
- Consent for use of tumor and blood samples for future research including DNA, RNA, and protein analysis
You will not qualify if you...
- Prior treatment with an ADC in a curative setting
- Lack of consent for sample use
- Presence of another progressive, life-threatening disease
- Concurrent treatment for a different malignancy or hematologic disorder
- Inadequate washout periods before treatment start, including recent brain radiation, chemotherapy, immunotherapy, hormonal therapy, major surgery, or extensive radiotherapy
- Pregnancy, breastfeeding, or planning pregnancy during the trial or within 90 days after treatment
- Being deprived of liberty, under protective custody, or guardianship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants receiving standard-of-care antibody-drug conjugates (ADCs) are observed with biological sample collections and patient-reported outcomes to identify biomarkers of ADC resistance and toxicity.
Regular biological sample collections before treatment start, during treatment, and at treatment discontinuation; questionnaires completed throughout the study period
Trial Site Locations
Total: 1 location
1
Gustave Roussy Cancer Center
Villejuif, France, 94805
Actively Recruiting
Research Team
M
Marjorie Mauduit
J
Jérôme Lemonnier
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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