NCT06400472RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 575 (estimated)
- First submitted
- 30 Apr 2024
- Start date
- 20 May 2024
- Primary completion date
- Jun 2029
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Triple-negative breast cancer, Endometrial cancer, Cervical cancer, Lung cancer, Pancreatic cancer, Colorectal cancer, Ovarian cancer
- NCT number
- NCT06400472
- EU CT number
- 2024-511238-11-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 575
- From 20 May 2024 to the primary completion date, Jun 2029
- 25 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any serious unresolved toxicities from prior therapy
Other illness
- 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
- Significant cardiovascular disease
- History of pneumonitis/interstitial lung disease
Lab values
- Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 milliseconds (ms)
Other
- Individual with known or suspected uncontrolled central nervous system (CNS) metastases
- Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (25)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Research SA Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
| Icon Cancer Centre South Brisbane Coordinator of this site? Confirm its status | QLD | Australia | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Institut De Cancerologie De L Ouest Coordinator of this site? Confirm its status | Saint-Herblain Cedex | France | Recruiting |
| Institut Universitaire Du Cancer Toulouse-Oncopole Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Recruiting |
| Istituto Europeo di Oncologia s.r.l Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Humanitas Mirasole S.p.A. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Shizuoka Cancer Center Coordinator of this site? Confirm its status | Shizuoka | Japan | Recruiting |
| Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| National Cancer Center Coordinator of this site? Confirm its status | Goyang-si Gyeonggi-do | South Korea | Recruiting |
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| The Ohio State University (OSU) Wexner Medical Center Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Inova Schar Cancer Institute Coordinator of this site? Confirm its status | Falls Church | United States | Not yet recruiting |
| South Texas Accelerated Research Therapeutics (START) Midwest Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| The University of Texas MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| University of California, San Diego (UCSD) - Moores Cancer Center Coordinator of this site? Confirm its status | La Jolla | United States | Recruiting |
| NYU Langone Health- Long Island Coordinator of this site? Confirm its status | Mineola | United States | Recruiting |
| New York University (NYU) Clinical Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| HonorHealth Coordinator of this site? Confirm its status | Scottsdale | United States | Recruiting |
| START Mountain Region Coordinator of this site? Confirm its status | West Valley City | United States | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.