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Official title Optimal Methods to Characterize ADC Resistance in Solid Tumors and Identify Clinically Useful Biomarkers
ClinicalTrials.gov ID: NCT07259226
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Patients must have at least 2 tumor lesions (primary tumor can be included): at least one measurable tumor lesion for tumor evaluation according to...
- Patients must have a metastatic or locally advanced tumor site easily accessible to biopsy (with exception of bone and brain metastasis) and must...
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- 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...
- 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...
- 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...
- Life expectancy must be ≥12 weeks according to the discretion of the investigator;
- 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Villejuif, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Villejuif, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.