A Study of LY4170156 in Participants With Selected Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Ovarian Neoplasms; Endometrial Neoplasms; Colorectal Neoplasms; Uterine Cervical Neoplasms; Pancreatic Neoplasm; Carcinoma, Non-Small-Cell Lung; Triple Negative Breast Neoplasms
• Interventions: Drug: LY4170156; Drug: Bevacizumab; Drug: carboplatin

• Registration Number: NCT06400472
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-30
• Study First Submitted QC: 2024-05-01
• Study First Posted: 2024-05-06
• Study Start: 2024-05-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-27
• Primary Completion: 2027-02
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

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/A3/A4/A5/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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY4170156 (Dose-escalation, Cohort A1)	LY4170156	Escalating doses of LY4170156 administered intravenously (IV).
LY4170156 (Dose-expansion, Cohort B1, B2, C1, C2)	LY4170156	LY4170156 administered IV.
LY4170156 (Dose-optimization, Cohort A2)	LY4170156	Comparing 2 or more doses (evaluated during dose escalation) of LY4170156 administered IV.
LY4170156 (Enrichment Cohort A3)	LY4170156	Monotherapy administered IV
LY4170156 (Combination Cohort A4)	LY4170156	Combination with bevacizumab administered IV
LY4170156 (Combination Cohort A4)	Bevacizumab	Combination with bevacizumab administered IV
LY4170156 (Combination Cohort A5)	LY4170156	Combination with carboplatin administered IV
LY4170156 (Combination Cohort A5)	carboplatin	Combination with carboplatin administered IV

Primary Outcome Measures

Name	Time	Method
Phase 1a: To determine the recommended phase 2 dose (RP2D) of LY4170156	1 Cycle (21 days)	Number of participants with dose-limiting toxicities (DLTs)
Phase 1a: To determine the RP2D or optimal dose of LY4170156 with bevacizumab	1 Cycle (21 days)	Number of participants with DLTs
Phase 1a: To determine the RP2D or optimal dose of LY4170156 with carboplatin	1 Cycle (21 days)	Number of participants with DLTs
Phase 1b: To assess the antitumor activity of LY4170156 Monotherapy: Overall response rate (ORR)	Up to Approximately 48 Months or 4 Years	ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)

Secondary Outcome Measures

Name	Time	Method
To characterize the pharmacokinetics (PK) properties of LY4170156: Minimum Plasma Concentration (Cmin)	First 4 Cycles (84 days)	PK: Cmin of LY4170156
To characterize the pharmacokinetics (PK) properties of LY4170156: Minimum Plasma Concentration (Cmin) with vevacizumab or carboplatin	First 4 Cycles (84 days)	PK: Cmin of LY4170156
To characterize the PK properties of LY4170156: Area under the concentration versus time curve (AUC)	First 4 Cycles (84 days)	PK: AUC of LY4170156
To evaluate the preliminary antitumor activity of LY4170156: Overall response rate (ORR)	Up to Approximately 48 Months or 4 Years	ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
To evaluate the preliminary antitumor activity of LY4170156: Overall response rate (ORR) with bevacizumab or carboplatin	Up to Approximately 48 Months or 4 Years	ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
To evaluate the preliminary antitumor activity of LY4170156: Duration of response (DOR)	Up to Approximately 48 Months or 4 Years	DOR per investigator assessed RECIST 1.1
To evaluate the preliminary antitumor activity of LY4170156: Duration of response (DOR) with bevacizumab or carboplatin	Up to Approximately 48 Months or 4 Years]	DOR per investigator assessed RECIST 1.1
To evaluate the preliminary antitumor activity of LY4170156: Time to response (TTR)	Up to Approximately 48 Months or 4 Years	TTR per investigator assessed RECIST 1.1
To evaluate the preliminary antitumor activity of LY4170156: Time to response (TTR) with bevacizumab or carboplatin	Up to Approximately 48 Months or 4 Years]	TTR per investigator assessed RECIST 1.1
To evaluate the preliminary antitumor activity of LY4170156: Progression free survival (PFS)	Up to Approximately 48 Months or 4 Years	PFS per investigator assessed RECIST 1.1
To evaluate the preliminary antitumor activity of LY4170156: Progression free survival (PFS) with bevacizumab or carboplatin	Up to Approximately 48 Months or 4 Years]	PFS per investigator assessed RECIST 1.1
To evaluate the preliminary antitumor activity of LY4170156: Disease control rate (DCR)	Up to Approximately 48 Months or 4 Years	DCR per investigator assessed RECIST 1.1
To evaluate the preliminary antitumor activity of LY4170156: Disease control rate (DCR) with bevacizumab or carboplatin	Up to Approximately 48 Months or 4 Years]	DCR per investigator assessed RECIST 1.1

Trial Locations

Locations (16)

Hospital Clinico Universitario de Valencia; 🇪🇸 Valencia, Spain

Honor Health Research Institute; 🇺🇸 Scottsdale, Arizona, United States

South Texas Accelerated Research Therapeutics (START); 🇺🇸 Grand Rapids, Michigan, United States

NYU Langone Health; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States

START Mountain Region; 🇺🇸 West Valley City, Utah, United States

Icon Cancer Centre South Brisbane Loc. 10; 🇦🇺 South Brisbane, Queensland, Australia

Cancer Research SA; 🇦🇺 Adelaide, South Australia, Australia

Centre Leon Berard; 🇫🇷 Lyon, Rhône, France

Shizuoka Cancer Center; 🇯🇵 Sunto-gun, Shizuoka, Japan

National Cancer Center Hospital; 🇯🇵 Chuo Ku, Tokyo, Japan

The Cancer Institute Hospital of JFCR; 🇯🇵 Tokyo, Japan

National Cancer Center; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of

Hospital Universitario Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain