A Study of Sofe-M in Participants With Selected Advanced Solid Tumors

A First-in-Human, Phase 1/2 Trial to Assess the Safety, Tolerability and Preliminary Efficacy of Sofetabart Mipitecan (LY4170156), an Antibody-Drug Conjugate Targeting Folate Receptor α-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06400472

Enrollment

575

Registered

2024-05-06

Start date

2024-05-20

Completion date

2029-06-01

Last updated

2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Folate receptor alpha, NSCLC, Ovarian cancer, Cervical cancer, Endometrial cancer, Solid tumor, Lung cancer, Breast cancer, Pancreatic cancer, Colorectal cancer, Anti-drug conjugate, Phase I, Chemotherapy, sofe-m

Brief summary

The purpose of this study is to find out whether the study drug, Sofetabart Mipitecan (LY4170156), is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in three parts - phase Ia (dose-escalation, dose-optimization), phase Ib (dose-expansion), and phase 2 (dose expansion). The study will last up to approximately 5 years.

Interventions

DRUGSofe-M

Intravenous

DRUGbevacizumab

DRUGcarboplatin

DRUGItraconazole

oral

DRUGpembrolizumab

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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, TNBC, and high grade endometrioid 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

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Up to Approximately 60 Months or 5 Years	A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
Phase 1a: To determine the recommended phase 2 dose (RP2D) of Sofe-M (LY4170156)	1 Cycle (21 or 28 days)	Number of participants with dose-limiting toxicities (DLTs)
Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with bevacizumab	1 Cycle (21 or 28 days)	Number of participants with DLTs
Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with carboplatin	1 Cycle (21 or 28 days)	Number of participants with DLTs
Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with pembrolizumab	1 Cycle (21 or 28 days)	Number of participants with DLTs
Phase 1b: To assess the antitumor activity of Sofe-M (LY4170156) Monotherapy: Overall response rate (ORR)	Up to Approximately 60 Months or 5 Years	ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Phase 2: To assess the antitumor activity of Sofe-M (LY4170156) Monotherapy: ORR	Up to Approximately 60 Months or 5 Years	ORR per RECIST 1.1

Secondary

Measure	Time frame	Description
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Overall response rate (ORR) with bevacizumab or carboplatin or pembrolizumab	Up to Approximately 60 Months or 5 Years	ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Duration of response (DOR)	Up to Approximately 60 Months or 5 Years	DOR per investigator assessed RECIST 1.1
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Duration of response (DOR) with bevacizumab or carboplatin or pembrolizumab	Up to Approximately 60 Months or 5 Years	DOR per investigator assessed RECIST 1.1
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Time to response (TTR)	Up to Approximately 60 Months or 5 Years	TTR per investigator assessed RECIST 1.1
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Time to response (TTR) with bevacizumab or carboplatin or pembrolizumab	Up to Approximately 60 Months or 5 Years	TTR per investigator assessed RECIST 1.1
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Progression free survival (PFS)	Up to Approximately 60 Months or 5 Years	PFS per investigator assessed RECIST 1.1
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Progression free survival (PFS) with bevacizumab or carboplatin or pembrolizumab	Up to Approximately 60 Months or 5 Years]	PFS per investigator assessed RECIST 1.1
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Disease control rate (DCR)	Up to Approximately 60 Months or 5 Years	DCR per investigator assessed RECIST 1.1
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Disease control rate (DCR) with bevacizumab or carboplatin or pembrolizumab	Up to Approximately 60 Months or 5 Years	DCR per investigator assessed RECIST 1.1
To characterize the pharmacokinetics (PK) properties of Sofe-M (LY4170156): Minimum Plasma Concentration (Cmin)	First 4 Cycles (84 days)	PK: Cmin of Sofe-M (LY4170156)
To characterize the PK properties of Sofe-M (LY4170156): Cmin with bevacizumab or carboplatin	First 4 Cycles (Approximately 84 days)	PK: Cmin of Sofe-M (LY4170156)
To characterize the PK properties of Sofe-M (LY4170156): Cmin with pembrolizumab	First 4 Cycles (84 days)	PK: Cmin of Sofe-M (LY4170156)
To characterize the PK properties of Sofe-M (LY4170156): Area under the concentration versus time curve (AUC)	First 4 Cycles (84 days)	PK: AUC of Sofe-M (LY4170156)
To characterize the patient-reported outcomes (PRO) Common Terminology Criteria for Adverse Events (CTCAE) of Sofe-M (LY4170156)	Up to Approximately 60 Months or 5 Years	PRO-CTCAE of Sofe-M (LY4170156)
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Overall response rate (ORR)	Up to Approximately 60 Months or 5 Years	ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)

Countries

Australia, France, Italy, Japan, South Korea, Spain, United States

Contacts

CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

LillyTrials@Lilly.com1-317-615-4559

CONTACTPhysicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026