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

ClinicalTrials.gov ID: NCT06400472

Public ClinicalTrials.gov record NCT06400472. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 6, 2026, 3:44 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT06400472
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1
Lead sponsor: Eli Lilly and Company; Industry
Enrollment: 575 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 19, 2024
Primary completion: May 31, 2029
Completion: May 31, 2029
Last update posted: Sep 3, 2026

2024 – 2029

United States locations

U.S. sites: 10
U.S. states: 8
U.S. cities: 9

Facility	City	State	ZIP	Site status
HonorHealth	Scottsdale	Arizona	85258	Recruiting
University of California, San Diego (UCSD) - Moores Cancer Center	La Jolla	California	92037	Recruiting
Emory University	Atlanta	Georgia	30308	Not yet recruiting
South Texas Accelerated Research Therapeutics (START) Midwest	Grand Rapids	Michigan	49546	Recruiting
NYU Langone Health - Long Island	Mineola	New York	11501	Recruiting
New York University (NYU) Clinical Cancer Center	New York	New York	10016	Recruiting
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center	New York	New York	10065	Recruiting
The Ohio State University (OSU) Wexner Medical Center	Columbus	Ohio	43210	Recruiting
The University of Texas - MD Anderson Cancer Center	Houston	Texas	77030-4000	Recruiting
START Mountain Region	West Valley City	Utah	84119	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 14 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06400472, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 3, 2026 · Synced Sep 6, 2026

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The complete protocol, eligibility criteria, and contact information for NCT06400472 live on ClinicalTrials.gov.

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