A Study of LY4170156 in Participants With Selected Advanced Solid Tumors

Lilly

Status and phase: Enrolling; Phase 1

Conditions: Uterine Cervical Neoplasms; Ovarian Neoplasms; Triple Negative Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms; Pancreatic Neoplasm; Endometrial Neoplasms

Treatments: Drug: LY4170156

Study type: Interventional

Funder types: Industry

Identifiers

NCT06400472

LOXO-FRA-24001

J5E-OX-JZXA (Other Identifier)

2024-511238-11-00

Details and patient eligibility

About

The purpose of this study is to find out whether the study drug, LY4170156, is safe, tolerable and effective in participants with advanced 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have one of the following solid tumor cancers:

  • Cohort A1: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) cancer, endometrial cancer, cervical cancer, non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), pancreatic, and colorectal cancer (CRC)
  • Cohort A2/B1/B2: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) cancer
  • Cohort C1/C2: Endometrial cancer, cervical cancer, NSCLC, TNBC, CRC or pancreatic cancer

Exclusion criteria

• Individual with known or suspected uncontrolled central nervous system (CNS) metastases
• Individual with history of carcinomatous meningitis
• Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
• Individual with evidence of corneal keratopathy or history of corneal transplant
• Any serious unresolved toxicities from prior therapy
• Significant cardiovascular disease
• Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 milliseconds (ms)
• History of pneumonitis/interstitial lung disease
• Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 3 patient groups

LY4170156 (Dose-escalation, Cohort A1)

Experimental group

Description:

Escalating doses of LY4170156 administered intravenously (IV).

Treatment:

Drug: LY4170156

LY4170156 (Dose-optimization, Cohort A2)

Experimental group

Description:

Comparing 2 or more doses (evaluated during dose escalation) of LY4170156 administered IV.

Treatment:

Drug: LY4170156

LY4170156 (Dose-expansion, Cohort B1, B2, C1, C2)

Experimental group

Description:

LY4170156 administered IV.

Treatment:

Drug: LY4170156