A Study of LY4170156 in Participants With Selected Advanced Solid Tumors

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

A First-in-Human, Phase 1a/1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4170156, an Antibody-Drug Conjugate Targeting Folate Receptor α-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06400472
• Other study ID #: LOXO-FRA-24001
• Secondary ID: 2024-511238-11-0
• Status: Recruiting
• Phase: Phase 1
• Start date: May 6, 2024
• Est. completion date: April 2027

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: Patient Advocacy
• Phone: 8555696305
• Email: clinicaltrials[@]loxooncology.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: April 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• LY4170156
Intravenous

Locations

Country	Name	City	State
United States	South Texas Accelerated Research Therapeutics (START)	Grand Rapids	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Loxo Oncology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1a: To determine the recommended phase 2 dose (RP2D) of LY4170156	Number of participants with dose-limiting toxicities (DLTs)	First 4 Cycles (21 days)
Primary	Phase 1a: To determine the RP2D or optimal dose of LY4170156	Number of participants with DLTs	First 4 Cycles (21 days)
Primary	Phase 1b: To assess the antitumor activity of LY4170156 Monotherapy: Overall response rate (ORR)	ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)	Up to Approximately 48 Months or 4 Years
Secondary	To characterize the pharmacokinetics (PK) properties of LY4170156: Minimum Plasma Concentration (Cmin)	PK: Cmin of LY4170156	First 4 Cycles (21 days)
Secondary	To characterize the PK properties of LY4170156: Area under the concentration versus time curve (AUC)	PK: AUC of LY4170156	First 4 Cycles (21 days)
Secondary	To evaluate the preliminary antitumor activity of LY4170156: Overall response rate (ORR)	ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)	Up to Approximately 48 Months or 4 Years
Secondary	To evaluate the preliminary antitumor activity of LY4170156: Duration of response (DOR)	DOR per investigator assessed RECIST 1.1	Up to Approximately 48 Months or 4 Years
Secondary	To evaluate the preliminary antitumor activity of LY4170156: Time to response (TTR)	TTR per investigator assessed RECIST 1.1	Up to Approximately 48 Months or 4 Years
Secondary	To evaluate the preliminary antitumor activity of LY4170156: Progression free survival (PFS)	PFS per investigator assessed RECIST 1.1	Up to Approximately 48 Months or 4 Years
Secondary	To evaluate the preliminary antitumor activity of LY4170156: Disease control rate (DCR)	DCR per investigator assessed RECIST 1.1	Up to Approximately 48 Months or 4 Years

External Links

•   A Study of LY4170156 in Participants With Selected Advanced Solid Tumors