Informations générales (source: ClinicalTrials.gov)
A Phase 1a/1b Study of LY4052031, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Advanced or Metastatic Urothelial Carcinoma or Other Solid Tumors
Interventional
Phase 1
Eli Lilly and Company (Voir sur ClinicalTrials)
juillet 2024
mai 2027
08 octobre 2026
The purpose of this study is to find out whether the study drug, LY4052031, is safe,
tolerable and effective in participants with advanced, or metastatic solid tumors
including urothelial cancer. 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 ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Capucine BALDINI | 07/10/2026 14:50:03 | Contacter | ||
Critères
Tous
- 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 C: triple negative breast cancer, non-small cell lung cancer, ovarian
cancer, cervical cancer, HNSCC (head and neck squamous cell carcinoma),
esophageal cancer, pancreatic cancer, or prostate cancer
- Prior Systemic Therapy Criteria:
- Cohort A1/C: 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/C: 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)
- Measurable disease is required as defined by Response Evaluation Criteria in
Solid Tumors v1.1 (RECIST v1.1) for all Cohorts. Cohort A1 may permit
non-measurable disease 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
Exclusion Criteria:
- Individual with known or suspected uncontrolled CNS metastases
- Individual with uncontrolled hypercalcemia
- Individual with uncontrolled diabetes
- Individual with evidence of corneal keratopathy or keratitis, and history of corneal
transplant
- Any serious unresolved toxicities from prior therapy
- Significant cardiovascular disease
- Recent thromboembolic event and/or clinically significant bleeding disorder
- 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