Clinical trial Recruiting at 24 sites Phase 1 Interventional Ages 18 and up

Evaluating LY4170156 for advanced solid tumors

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

Run by Eli Lilly and Company · NCT06400472 · Data updated 2026-11-12

This study is testing a new drug called LY4170156 to see if it is safe and effective for people with advanced solid tumors like ovarian and lung cancers.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment575 (estimated)
SponsorEli Lilly and Company
Industry-sponsored
Locations25 sites (Scottsdale, Arizona and 24 other locations)
StatusRecruiting
StartedMay 20, 2024
Main results expectedJune 2029
Study endsJune 2029
Registry record updatedNovember 4, 2026
Trial IDNCT06400472 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals with advanced ovarian, endometrial, cervical, non-small cell lung, or triple-negative breast cancers.

Probably not a fit

Patients with uncontrolled central nervous system metastases or significant cardiovascular disease may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety, tolerability, and effectiveness of the drug LY4170156 in patients with selected advanced solid tumors. It is structured in two parts: a phase Ia for dose-escalation and optimization, followed by a phase Ib for dose-expansion. The trial aims to enroll participants with various types of cancers, including ovarian, endometrial, cervical, non-small cell lung, and triple-negative breast cancers. The study is expected to last approximately four years.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors.

How similar studies have gone: Other studies have shown promise with similar approaches targeting advanced solid tumors, indicating potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • HonorHealth
    Scottsdale, Arizona, United States
    Recruiting
  • University of California, San Diego (UCSD) - Moores Cancer Center
    La Jolla, California, United States
    Recruiting
  • Emory University
    Atlanta, Georgia, United States
    Recruiting
  • South Texas Accelerated Research Therapeutics (START) Midwest
    Grand Rapids, Michigan, United States
    Recruiting
  • NYU Langone Health - Long Island
    Mineola, New York, United States
    Recruiting
  • New York University (NYU) Clinical Cancer Center
    New York, New York, United States
    Recruiting
Show 19 more locations
  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
    New York, New York, United States
    Recruiting
  • The Ohio State University (OSU) Wexner Medical Center
    Columbus, Ohio, United States
    Recruiting
  • The University of Texas - MD Anderson Cancer Center
    Houston, Texas, United States
    Recruiting
  • START Mountain Region
    West Valley City, Utah, United States
    Recruiting
  • Cancer Research SA
    Adelaide, Australia
    Recruiting
  • Icon Cancer Centre South Brisbane
    Qld, Australia
    Recruiting
  • Centre Leon Berard
    Lyon, France
    Recruiting
  • Institut de Cancerologie de l'Ouest - site St-Herblain
    Saint-Herblain, France
    Recruiting
  • Oncopole Claudius Regaud
    Toulouse, France
    Recruiting
  • Humanitas San Pio X
    Milan, Italy
    Recruiting
  • Istituto Europeo di Oncologia
    Milan, Italy
    Recruiting
  • Shizuoka Cancer Center
    Shizuoka, Japan
    Recruiting
  • National Cancer Center Hospital
    Tokyo, Japan
    Recruiting
  • Cancer Institute Hospital of JFCR
    Tokyo, Japan
    Recruiting
  • National Cancer Center
    Goyang-si Gyeonggi-do, South Korea
    Recruiting
  • Hospital Universitario Vall d'Hebron
    Barcelona, Spain
    Recruiting
  • Hospital Universitario 12 de Octubre
    Madrid, Spain
    Recruiting
  • Hospital Clinico Universitario de Valencia
    Valencia, Spain
    Recruiting
  • Inova Schar Cancer Institute
    Falls Church, Virginia, United States
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Testing UCB4594 for advanced cancer treatment

    This study is testing a new drug called UCB4594 to see if it can help treat advanced cancer by targeting a specific protein on cancer cells.

    Recruiting at 3 sites Phase 1/2 Cancer Research UK · London and 3 other locations · NCT06380816

  • Dabrafenib and trametinib for rare cancers with BRAF V600 mutations

    This arm tests whether dabrafenib and trametinib can help adults, children, and teens with cancers that have a BRAF V600 mutation.

    Recruiting at 15 sites Phase 2/3 Cancer Research UK · Belfast and 26 other locations · NCT07440290

  • Testing DM002 in patients with advanced solid tumors

    This study is testing a new drug called DM002 to see if it is safe and effective for people with advanced solid tumors.

    Recruiting at 7 sites Phase 1/2 Doma Biopharmaceutical(Suzhou)Co., Ltd. · San Francisco, California and 6 other locations · NCT06751329

  • Evaluating NKT3964 for Adults with Advanced Solid Tumors

    This study is testing a new drug called NKT3964 to see if it can safely help adults with advanced solid tumors, like ovarian or triple-negative breast cancer, after other treatments have failed.

    Recruiting at 17 sites Phase 1 NiKang Therapeutics, Inc. · Little Rock, Arkansas and 20 other locations · NCT06586957

  • Combination of trastuzumab and pertuzumab for treating cancers with HER2 mutations

    This study is testing if a combination of two cancer drugs, trastuzumab and pertuzumab, can help adults and young people with cancers that have HER2 mutations or amplifications.

    Recruiting at 24 sites Phase 2/3 Cancer Research UK · Belfast and 26 other locations · NCT05786716

  • Combination of vemurafenib and cobimetinib for treating BRAF positive cancers

    This study is testing if the combination of vemurafenib and cobimetinib can help adults with different types of cancers that have a specific BRAF mutation.

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.