臨床研究等提出・公開システム

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 (J5I-OX-JZYA)

A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors (J5I-OX-JZYA)

Masaki Takeshi

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

LTG_CallCenter@lists.lilly.com

Trial Guide Call Center

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

+81-120-023-812

LTG_CallCenter@lists.lilly.com

Suspended

Sept. 30, 2024

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

parallel assignment

treatment purpose

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, 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)
* Cohorts A2, B1, B2, C: 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 keratitis, and history of corneal transplant
Any serious unresolved toxicities from prior therapy
Significant cardiovascular disease
Recent thromboembolic event or 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

Both

Metastatic Solid Tumor
Recurrent Solid Tumor
Advanced Solid Tumor

DRUG: LY4052031
Intravenous

[Study Arms]
Experimental: LY4052031 (Dose-escalation, Cohort A1)
Escalating doses of LY4052031 administered intravenously (IV).
Interventions:
Drug: LY4052031
Experimental: LY4052031 (Dose-optimization, Cohort A2)
Comparing 2 or more doses (evaluated during dose escalation) of LY4052031 administered IV.
Interventions:
Drug: LY4052031
Experimental: LY4052031 (Dose-expansion, Cohort B1, B2, C1)
LY4052031 administered IV.
Interventions:
Drug: LY4052031

Phase 1a: To determine the recommended phase 2 dose (RP2D) or optimal dose of LY4052031 [ Time Frame: Cycle 1 (21 Days)]
Number of participants with dose-limiting toxicities (DLTs)

Phase 1b: To assess the antitumor activity of LY4052031 Monotherapy: Overall response rate (ORR) [Time Frame: Up to Approximately 48 Months or 4 Years]
ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)

+81-3-3520-0111

No

United States