Advanced Breast CancerPhase 2OASISNCT07259226
Optimal Methods to Characterize ADC Resistance in Solid Tumors and Identify Clinically Useful Biomarkers
A Phase 2 study testing Biological samples collection and questionnaires to collect patient reported outcomes in people with Advanced Breast Cancer and Advanced Gastric Cancer, run by UNICANCER at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Breast Cancer, Advanced Gastric Cancer, Advanced Urothelial Cancer
- What is being tested?
- Biological samples collection and questionnaires to collect patient reported outcomes
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 14 Nov 2025to 1 Nov 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Patients must have a metastatic or locally advanced tumor site easily accessible to biopsy (with exception of bone and brain metastasis) and must have agreed to perform pretreatment and post-treatment biopsies; an archival pre-treatment biopsy may be used if it was collected within one month of enrolment, if no anticancer therapy was administered after the biopsy and if sufficient material is available for research;
- Life expectancy must be ≥12 weeks according to the discretion of the investigator;
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- ECOG performance status ≤ 2;
- Patients must have adequate hematologic and organ function, compatible with ADC administration, as per drug-specific recommendations;
- Women of childbearing potential and male patient must agree to use adequate contraception for the duration of trial participation and up to 7 months after completing treatment for women and up to 4 months for men;
- Patients must be affiliated to a social security system (or equivalent);
- Patients must be willing and able to comply with the protocol for the duration of the trial;
- Patients must consent to the use of their collected tumor specimen, as well as, blood samples as detailed in the protocol for future scientific research, which includes but is not limited to DNA, RNA, and protein-based biomarker analysis.
Who cannot join
- 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.
- Patients with inadequate washout period prior to Cycle 1 Day 1, defined as:
- Whole brain radiation therapy <14 days or stereotactic brain radiation therapy <7 days.
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- Any cytotoxic chemotherapy, investigational agents or other anticancer drug(s) (including another ADC) from a previous cancer treatment regimen or clinical study (other than epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI)), <14 days or 5 half-lives, whichever is longer.
- Immune checkpoint inhibitor therapy <21 days.
- Hormonal therapy <21 days.
- Major surgery (excluding placement of vascular access) <28 days.
- Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation <28 days or palliative radiation therapy <14 days.
- Female participant who is pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 90 days after the final administration of study treatment;
- Person deprived of their liberty or under protective custody or guardianship.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jérôme Lemonnier contact
France1 site, 1 recruiting
- Recruiting
Gustave Roussy Cancer Center
Villejuif, 94805
Barbara PISTILLI, MD, +33 (0)1 42 11 61 62, barbara.pistilli@gustaveroussy.fr
Noemie CORCOS, PhD, + 33 (0) 1 42 11 51 58, Noemie.CORCOS@gustaveroussy.fr
About this study
Official title: International Multicenter Multicohort Open-label Phase II Trial Aiming to Define Optimal Methods for Predicting Response/Resistance to Antibody-drug Conjugates in Patients With Solid Tumors Treated According to Current Standard Indications.
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.
Read the detailed description
Over the past five years, antibody-drug conjugates (ADCs) have dramatically improved survival in solid and hematologic malignancies. Among 14 ADCs approved worldwide, nine are now available in Europe, and over 370 others are in clinical development. This expanding landscape indicates that ADCs could soon replace conventional chemotherapy across multiple tumor types. Given this rapid evolution, clinicians will need to select the most suitable ADC for each patient, considering tumor biology, microenvironment (TME) and patient-specific factors. Yet, despite remarkable efficacy, resistance to ADCs eventually arises. Understanding resistance mechanisms is therefore essential to guide therapeutic sequencing and optimize next-generation ADCs.
ADCs are complex molecules combining an antibody, a linker, and a cytotoxic payload. Their activity depends on factors such as antigen expression, internalization, linker stability, and payload sensitivity. Resistance can result from altered vascular perfusion, antigen downregulation, defective internalization or trafficking, impaired linker cleavage, drug efflux, or payload target modifications. These multifactorial processes differ from those driving resistance to traditional chemotherapies. Existing preclinical and clinical tools (Patient-Derived Xenograft(PDX)/Cell-line-Derived Xenograft (CDX) models, standard imaging, Immunohistochemistry (IHC), genomic profiling) fail to capture this complexity or predict ADC efficacy and resistance. Furthermore, ADCs often cause significant toxicities-on-target or off-target-affecting the ocular surface, skin, lungs, and peripheral nerves. Patient factors such as age, comorbidities, and weight influence these events. Understanding the determinants of toxicity is critical to maintain quality of life and treatment adherence.
The OASIS program aims to identify predictive biomarkers of ADC response and toxicity to enable personalized ADC selection and toxicity prevention. This multicenter study will integrate advanced technologies-digital pathology, liquid biopsy, and Patient-derived organoids (PDOs)-to generate comprehensive biological and clinical data. Using these datasets, a multimodal machine-learning model (OASIS Multiparametric Score) will be developed to predict both efficacy and key toxicities of ADCs. The project will prospectively include patients receiving ADCs in standard practice, with longitudinal tumor and blood sampling to investigate biomarkers of resistance and toxicity. In parallel, preclinical models derived from patient tumors will explore resistance mechanisms and screen ADC sensitivity.
A retrospective cohort of patients previously treated with ADCs will first be analyzed to prioritize biomarker candidates based on published data and prior findings. From this, five binary biomarkers will be selected for the primary objective. Combined with prospective data, this retrospective work will expand the translational biobank and support the construction of the OASIS score.
- Conditions
- Advanced Breast Cancer, Advanced Gastric Cancer, Advanced Urothelial Cancer, Advanced Non Small Cell Lung Cancer (NSCLC)
- Being tested
- Biological samples collection, questionnaires to collect patient reported outcomes
- Keywords
- ADC, resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological samples collectionProcedure or surgery
Also called Blood sample collection, Sputum sample collection, Tumor tissue sample collection
Biological samples collection (tumor tissue, blood, sputum) before initiation of treatment, during treatment, and at treatment discontinuation.
questionnaires to collect patient reported outcomesBehavioural
QLQ-C30, QLQ-FA12, HADS, EQ-5D 5L
| Study group | Role | What they receive |
|---|---|---|
| T-DXd (trastuzumab deruxtecan) | Other | Standard of care T-DXd indication Receives: Procedure: Biological samples collection; Behavioral: questionnaires to collect patient reported outcomes |
| T-DM1 (trastuzumab emtansine) | Other | Standard of care T-DM1 indication Receives: Procedure: Biological samples collection; Behavioral: questionnaires to collect patient reported outcomes |
| SG (sacituzumab govitecan) | Other | Standard of care SG indication Receives: Procedure: Biological samples collection; Behavioral: questionnaires to collect patient reported outcomes |
| EV (enfortumab vedotin) | Other | Standard of care EV indication Receives: Procedure: Biological samples collection; Behavioral: questionnaires to collect patient reported outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers of resistance to ADC
Resistance is defined by differences in the frequency (higher or lower) of molecular aberrations detected between paired baseline samples and progression samples (i.e., samples collected at the time of disease progression under ADC treatment)
Measured: Through study completion, an average of 3 years
Secondary outcomes (12)
Additional biomarkers of resistance characterised by histology
Differences in the frequency of molecular aberrations characterised by histologic/proteomic/genomic/transcriptomic analysis between samples of patients progressing on ADC and paired pre-treatment samples (beyond biomarkers of primary outcome)
Measured: Through study completion, an average of 3 years
Biomarkers of ADC outcome
Progression-Free Survival (PFS) defined as the time from start of treatment and radiological progression or death, whichever occurs first. Tumor assessments are made by local investigators as per standard practice (RECIST 1.1.). Patients still alive at the cut-off time without documented progression (including lost to follow-up) will be censored at the time of latest evaluable efficacy assessment.
Measured: From first day of cycle 1 (each cycle is 21 to 28 days) to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Biomarkers of ADC outcome
Objective Response Rate (ORR) defined as the proportion of patients with a confirmed complete response (CR) or partial response (PR) assessed by investigators after 6 months of treatment.
Measured: From first day of cycle 1 (each cycle is 21 to 28 days) to date of 6 months of treatment completion
Biomarkers of ADC outcome
Clinical Benefit Rate (CBR) defined as the proportion of patients who had a CR, PR, or stable disease for 6 months or more.
Measured: From first day of cycle 1 (each cycle is 21 to 28 days) to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Biomarkers of resistance to ADC
Duration of response (DOR) defined as the time from treatment initiation to disease progression or death for patients who achieve CR or PR.
Measured: From first day of cycle 1 (each cycle is 21 to 28 days) to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Biomarkers of ADC outcome
Overall Survival (OS) defined as the time from inclusion to death due to any cause. Patients still alive at the cut-off time (including lost to follow-up) will be censored at the last known alive date.
Measured: From first day of cycle 1 (each cycle is 21 to 28 days) to date of death from any cause, assessed up to 60 months
Expression of ADC target measured on CTC and within tumor tissue
Concordance between ADC target expression (HER2, TROP-2, Nectin-4) on pre- and post-treatment tumor biopsy (IHC) and antigen expression on Circulating Tumor Cells (CTCs).
Measured: Through study completion, an average of 3 years
Patients' reported outcomes (PROs)
Overall quality of life will be assessed using the EORTC-QLQ-C30 and EQ-5D-5L at Baseline, after 3 months of treatment completion, at treatment discontinuation (for progression or any other reason)
Measured: Through study completion, an average of 3 years
Patients' reported outcomes (PROs)
Fatigue will be assessed using QLQ-FA12 at Baseline, after 3 months of treatment completion, at treatment discontinuation (for progression or any other reason).
Measured: Through study completion, an average of 3 years
Patients' reported outcomes (PROs)
Anxiety and depression will be assessed using HADS questionnaire at Baseline, after 3 months of treatment completion, at treatment discontinuation (for progression or any other reason)
Measured: Through study completion, an average of 3 years
Treatment cost
Number of resources consumed in terms of treatment, hospitalization (for drug administration and toxicity), biological and radiological exams during the ADC treatment, in order to calculated the corresponding management cost.
Measured: Through study completion, an average of 3 years
ADC-related specific toxicities
Safety as measured by the frequency and severity of key ADC toxicity (Interstitial Lung Disease, skin toxicity, ocular toxicity, peripheral neuropathy) as measured by NCI-CTCAE v 5.0.
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start14 Nov 2025
- Primary completion1 Nov 2030 (estimated)
- Study completion1 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara Pistilli, MD, PhD, Principal investigator, Gustave Roussy Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259226
- Sponsor's protocol ID
- UC-TRA-2507
- Other IDs
- ID RCB 2025-A01462-47
- Acronym
- OASIS
- Status last verified
- Aug 2025
- First submitted
- 26 Sep 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Multicenter Multicohort Open-label Phase II Trial Aiming to Define Optimal Methods for Predicting Response/Resistance to Antibody-drug Conjugates in Patients With Solid Tumors Treated According to Current Standard Indications.
- ClinicalTrials.gov ID
- NCT07259226
- Acronym / sponsor ID
- OASIS / UC-TRA-2507
- Conditions
- Advanced Breast Cancer, Advanced Gastric Cancer, Advanced Urothelial Cancer, Advanced Non Small Cell Lung Cancer (NSCLC)
- Keywords
- ADC, resistance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 1 Nov 2030 (estimated)
- Study completion
- 1 Nov 2030 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Over the past five years, antibody-drug conjugates (ADCs) have dramatically improved survival in solid and hematologic malignancies. Among 14 ADCs approved worldwide, nine are now available in Europe, and over 370 others are in clinical development. This expanding landscape indicates that ADCs could soon replace conventional chemotherapy across multiple tumor types. Given this rapid evolution, clinicians will need to select the most suitable ADC for each patient, considering tumor biology, microenvironment (TME) and patient-specific factors. Yet, despite remarkable efficacy, resistance to ADCs eventually arises. Understanding resistance mechanisms is therefore essential to guide therapeutic sequencing and optimize next-generation ADCs.
ADCs are complex molecules combining an antibody, a linker, and a cytotoxic payload. Their activity depends on factors such as antigen expression, internalization, linker stability, and payload sensitivity. Resistance can result from altered vascular perfusion, antigen downregulation, defective internalization or trafficking, impaired linker cleavage, drug efflux, or payload target modifications. These multifactorial processes differ from those driving resistance to traditional chemotherapies. Existing preclinical and clinical tools (Patient-Derived Xenograft(PDX)/Cell-line-Derived Xenograft (CDX) models, standard imaging, Immunohistochemistry (IHC), genomic profiling) fail to capture this complexity or predict ADC efficacy and resistance. Furthermore, ADCs often cause significant toxicities-on-target or off-target-affecting the ocular surface, skin, lungs, and peripheral nerves. Patient factors such as age, comorbidities, and weight influence these events. Understanding the determinants of toxicity is critical to maintain quality of life and treatment adherence.
The OASIS program aims to identify predictive biomarkers of ADC response and toxicity to enable personalized ADC selection and toxicity prevention. This multicenter study will integrate advanced technologies-digital pathology, liquid biopsy, and Patient-derived organoids (PDOs)-to generate comprehensive biological and clinical data. Using these datasets, a multimodal machine-learning model (OASIS Multiparametric Score) will be developed to predict both efficacy and key toxicities of ADCs. The project will prospectively include patients receiving ADCs in standard practice, with longitudinal tumor and blood sampling to investigate biomarkers of resistance and toxicity. In parallel, preclinical models derived from patient tumors will explore resistance mechanisms and screen ADC sensitivity.
A retrospective cohort of patients previously treated with ADCs will first be analyzed to prioritize biomarker candidates based on published data and prior findings. From this, five binary biomarkers will be selected for the primary objective. Combined with prospective data, this retrospective work will expand the translational biobank and support the construction of the OASIS score.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| T-DXd (trastuzumab deruxtecan) | Other | Procedure: Biological samples collection, Behavioral: questionnaires to collect patient reported outcomesStandard of care T-DXd indication |
| T-DM1 (trastuzumab emtansine) | Other | Procedure: Biological samples collection, Behavioral: questionnaires to collect patient reported outcomesStandard of care T-DM1 indication |
| SG (sacituzumab govitecan) | Other | Procedure: Biological samples collection, Behavioral: questionnaires to collect patient reported outcomesStandard of care SG indication |
| EV (enfortumab vedotin) | Other | Procedure: Biological samples collection, Behavioral: questionnaires to collect patient reported outcomesStandard of care EV indication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
- Patients must have a metastatic or locally advanced tumor site easily accessible to biopsy (with exception of bone and brain metastasis) and must have agreed to perform pretreatment and post-treatment biopsies; an archival pre-treatment biopsy may be used if it was collected within one month of enrolment, if no anticancer therapy was administered after the biopsy and if sufficient material is available for research;
Key exclusion criteria (13 listed)
- 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.
- Patients with inadequate washout period prior to Cycle 1 Day 1, defined as:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological samples collectionAlso: Blood sample collection, Sputum sample collection, Tumor tissue sample collectionBiological samples collection (tumor tissue, blood, sputum) before initiation of treatment, during treatment, and at treatment discontinuation. | Procedure or surgery | EV (enfortumab vedotin), SG (sacituzumab govitecan), T-DM1 (trastuzumab emtansine), T-DXd (trastuzumab deruxtecan) |
| questionnaires to collect patient reported outcomesQLQ-C30, QLQ-FA12, HADS, EQ-5D 5L | Behavioural | EV (enfortumab vedotin), SG (sacituzumab govitecan), T-DM1 (trastuzumab emtansine), T-DXd (trastuzumab deruxtecan) |
Primary outcome
Biomarkers of resistance to ADC
Time frame: Through study completion, an average of 3 years
Resistance is defined by differences in the frequency (higher or lower) of molecular aberrations detected between paired baseline samples and progression samples (i.e., samples collected at the time of disease progression under ADC treatment)
12 secondary outcomes
Additional biomarkers of resistance characterised by histology
Time frame: Through study completion, an average of 3 years
Biomarkers of ADC outcome
Time frame: From first day of cycle 1 (each cycle is 21 to 28 days) to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Biomarkers of ADC outcome
Time frame: From first day of cycle 1 (each cycle is 21 to 28 days) to date of 6 months of treatment completion
Biomarkers of ADC outcome
Time frame: From first day of cycle 1 (each cycle is 21 to 28 days) to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Biomarkers of resistance to ADC
Time frame: From first day of cycle 1 (each cycle is 21 to 28 days) to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Biomarkers of ADC outcome
Time frame: From first day of cycle 1 (each cycle is 21 to 28 days) to date of death from any cause, assessed up to 60 months
Expression of ADC target measured on CTC and within tumor tissue
Time frame: Through study completion, an average of 3 years
Patients' reported outcomes (PROs)
Time frame: Through study completion, an average of 3 years
Patients' reported outcomes (PROs)
Time frame: Through study completion, an average of 3 years
Patients' reported outcomes (PROs)
Time frame: Through study completion, an average of 3 years
Treatment cost
Time frame: Through study completion, an average of 3 years
ADC-related specific toxicities
Time frame: Through study completion, an average of 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jérôme Lemonnier contact
Barbara Pistilli, MD, PhD principal investigator
Gustave Roussy Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biological samples collection and questionnaires to collect patient reported outcomes in people with Advanced Breast Cancer and Advanced Gastric Cancer, run by UNICANCER at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marjorie Mauduit (+33 6 30481792, m-mauduit@unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers of resistance to ADC (time frame: Through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.