Informations générales (source: ClinicalTrials.gov)
A Phase 1 Trial Investigating LY4101174, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Recurrent, Advanced or Metastatic Solid Tumors
Interventional
Phase 1
Eli Lilly and Company (Voir sur ClinicalTrials)
mars 2024
mars 2027
13 août 2025
The purpose of this study is to find out whether the study drug, LY4101174, is safe,
tolerable and effective in participants with select advanced or metastatic solid tumors.
The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and
phase Ib (dose-expansion). The study will last up to approximately 4 years.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Leon Berard - 69373 - Lyon Cedex 08 - France | Contact (sur clinicalTrials) | ||||
| Centre Oscar Lambret - 59020 - Lille - Nord-Pas-de-Calais - France | Contact (sur clinicalTrials) | ||||
| Institut de cancérologie Strasbourg Europe - 67200 - Strasbourg - Strasbourg, Alsace - France | Contact (sur clinicalTrials) | ||||
| Institut Paoli-Calmettes - 13273 - Marseille - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Have one of the following solid tumor cancers:
- Cohort A1: urothelial carcinoma, triple negative breast cancer, non-small cell
lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical
cancer (squamous cell carcinoma), head and neck squamous cell carcinoma or
prostate cancer
- Cohort A2/B1/B2: urothelial carcinoma
- Cohort C1: triple negative breast cancer
- Cohort C2: non-small cell lung cancer
- Cohort C3: ovarian or fallopian tube cancer
- Cohort C4: cervical cancer
- Cohort C5: head and neck squamous cell carcinoma
- Prior Systemic Therapy Criteria:
- Cohort A1/C1-5: Individual has received all standard therapies for which the
participant was deemed to be an appropriate candidate by the treating
investigator; OR there is no standard therapy available for the disease. There
is no restriction on number of prior therapies
- Cohort A2/B1/B2: Individual must have received at least one prior regimen in
the advanced or metastatic setting. There is no restriction on number of prior
therapies.
- Prior enfortumab vedotin specific requirements:
- Cohorts A1/A2/C1-5: prior treatment with enfortumab vedotin is allowed, but not
required
- Cohort B1: individual must be enfortumab vedotin naive in the
advanced/metastatic setting
- Cohort B2: individual must have received enfortumab vedotin in the
metastatic/advanced setting.
- Measurability of disease
- Cohort A1: measurable or non-measurable disease as defined by Response
Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)
- Cohorts A2, B1, B2, C1-5: measurable disease required as defined by RECIST v1.1
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Have adequate archival tumor tissue sample available or undergo a screening biopsy
if allowed per country specific regulations
- Have one of the following solid tumor cancers:
- Cohort A1: urothelial carcinoma, triple negative breast cancer, non-small cell
lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical
cancer (squamous cell carcinoma), head and neck squamous cell carcinoma or
prostate cancer
- Cohort A2/B1/B2: urothelial carcinoma
- Cohort C1: triple negative breast cancer
- Cohort C2: non-small cell lung cancer
- Cohort C3: ovarian or fallopian tube cancer
- Cohort C4: cervical cancer
- Cohort C5: head and neck squamous cell carcinoma
- Prior Systemic Therapy Criteria:
- Cohort A1/C1-5: Individual has received all standard therapies for which the
participant was deemed to be an appropriate candidate by the treating
investigator; OR there is no standard therapy available for the disease. There
is no restriction on number of prior therapies
- Cohort A2/B1/B2: Individual must have received at least one prior regimen in
the advanced or metastatic setting. There is no restriction on number of prior
therapies.
- Prior enfortumab vedotin specific requirements:
- Cohorts A1/A2/C1-5: prior treatment with enfortumab vedotin is allowed, but not
required
- Cohort B1: individual must be enfortumab vedotin naive in the
advanced/metastatic setting
- Cohort B2: individual must have received enfortumab vedotin in the
metastatic/advanced setting.
- Measurability of disease
- Cohort A1: measurable or non-measurable disease as defined by Response
Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)
- Cohorts A2, B1, B2, C1-5: measurable disease required as defined by RECIST v1.1
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Have adequate archival tumor tissue sample available or undergo a screening biopsy
if allowed per country specific regulations
- Individual with known or suspected uncontrolled CNS metastases
- Individual with uncontrolled hypercalcemia
- Individual with uncontrolled diabetes
- Individual with evidence of corneal keratopathy or history of corneal transplant
- Any serious unresolved toxicities from prior therapy
- Significant cardiovascular disease
- Current of history of intestinal obstruction in the previous 3 months
- Recent thromboembolic event and/or clinically significant bleeding
- Prolongation of QT interval corrected for heart rate using Fridericia's formula
(QTcF) ≥ 470 ms
- History of pneumonitis/interstitial lung disease
- History of Grade ≥3 skin toxicity when receiving enfortumab vedotin
- Individuals who are pregnant, breastfeeding or plan to breastfeed during study or
within 30 days of last dose of study intervention
- Individual with active uncontrolled infection