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: carboplatin; Drug: bevacizumab; Drug: LY4170156; Drug: pembrolizumab; Drug: Itraconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT06400472

LOXO-FRA-24001

J5E-OX-JZXA (Other Identifier)

18863

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: 495 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have one of the following solid tumor cancers:

  • Dose Escalation: 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 cancer, or colorectal cancer (CRC)
  • Dose Optimization: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) and endometrial cancer
  • Dose Expansion: Low grade serous ovarian cancer, cervical cancer, NSCLC, and TNBC

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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495 participants in 9 patient groups

LY4170156 (Dose-escalation, Cohort A1)

Experimental group

Description:

Escalating doses of LY4170156 administered intravenously (IV)

Treatment:

Drug: LY4170156

LY4170156 (Cohort A1 Parts A and C)

Experimental group

Description:

LY4170156 administered IV

Treatment:

Drug: LY4170156

LY4170156 Alone or with Itraconazole. Drug-Drug Interaction (DDI) (Cohort A1: Arm B)

Experimental group

Description:

LY4170156 administered IV and itraconazole administered orally

Treatment:

Drug: Itraconazole

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 (Enrichment Cohort A3)

Experimental group

Description:

Monotherapy administered IV

Treatment:

Drug: LY4170156

LY4170156 (Combination Cohort A4)

Experimental group

Description:

Combination with bevacizumab administered IV

Treatment:

Drug: LY4170156

Drug: bevacizumab

LY4170156 (Combination Cohort A5)

Experimental group

Description:

Combination with carboplatin administered IV

Treatment:

Drug: LY4170156

Drug: carboplatin

LY4170156 Combination with Pembrolizumab (Dose-optimization Cohort A6)

Experimental group

Description:

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

Treatment:

Drug: pembrolizumab

Drug: LY4170156

LY4170156 (Dose-expansion, Cohort B1-B4)

Experimental group

Description:

LY4170156 administered IV

Treatment:

Drug: LY4170156