A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors
Esophogeal Cancer
Gynecologic Cancers
Lung Cancer
Ovarian Cancer
Prostate Cancer
18 Years and older, Male and Female
LOXO-ENC-23001 (primary)
NCI-2024-02612
2023-509867-26-00
J5A-OX-JZWA
Summary
The purpose of this study is to find out whether the study drug, LY4101174, is safe,
tolerable and effective in participants with 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.
Objectives
This is a Phase 1a/1b multicenter, open-label study in participants with advanced or
metastatic solid tumor malignancies known to express Nectin 4. This study is comprised of
two phases: Dose Escalation and Dose Optimization (1a), and Dose expansion (1b). Phase 1a
will assess the safety, tolerability, and pharmacokinetics of LY4101174 to determine the
recommended phase 2 dose (RP2D)/optimal dose. Phase 1b will evaluate efficacy and safety
of LY4101174 at the RP2D/optimal dose in 7 expansion cohorts based on tumor type and/or
treatment history.
Eligibility
- 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
Treatment Sites in Georgia
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