Actively Recruiting

Phase 1
Age: 18Years +
All Genders
ID07046923

A First-in-Human Trial to Assess Safety and Early Effectiveness of LY4175408, an Antibody Drug Conjugate, in Participants With Selected Advanced Solid Tumors

Led by Eli Lilly and Company · Updated on 2026-06-02

240

Participants Needed

27

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and preliminary effectiveness of LY4175408, an antibody drug conjugate, in people with selected advanced solid tumors such as non-small cell lung cancer, small cell lung cancer, endometrial cancer, and triple negative breast cancer. This Phase 1a/1b trial also studies how LY4175408 moves through and is processed by the body. Participation in the study could last up to 4 years. Participants receive LY4175408 through intravenous (IV) infusion, with doses adjusted during an initial escalation phase. Some participants may also receive pembrolizumab alone or combined with chemotherapy drugs carboplatin or cisplatin, all given by IV. The study includes several groups, such as dose escalation, dose optimization, and dose expansion cohorts, with treatments tailored based on disease status and prior therapies. During the study, participants undergo regular assessments including monitoring for dose-limiting toxicities, tumor response evaluations, and pharmacokinetic blood tests to measure drug levels. Researchers will track outcomes like overall response rate, progression-free survival, and duration of response up to about 4 years. Safety and tolerability are closely observed throughout the trial to understand LY4175408's effects over time.

CONDITIONS

Brief Title

A Study of LY4175408 in Participants With Advanced Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Diagnosed with advanced or metastatic non-small cell lung cancer, small cell lung cancer, endometrial cancer, or triple negative breast cancer
  • Have received all standard therapies appropriate for their condition or have no standard treatment options available
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Measurable disease per RECIST v1.1 for dose optimization and expansion cohorts
  • For certain cohorts, no prior systemic therapy or limited prior therapy for advanced disease as specified
Not Eligible

You will not qualify if you...

  • Prior treatment with a PTK7 antibody-drug conjugate containing a topoisomerase I inhibitor payload
  • Unresolved serious toxicities from prior treatments
  • Known or suspected uncontrolled central nervous system metastases
  • Active uncontrolled infections (bacterial, viral, fungal, or parasitic)
  • Significant cardiovascular disease
  • Prolonged QT interval (QTcF > 470 ms)
  • History of pneumonitis or interstitial lung disease
  • Pregnant, breastfeeding, or planning to breastfeed during the trial or within 30 days after last dose

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Repeated 21-day cycles until disease progression or discontinuation

Participants receive intravenous infusions of LY4175408 alone or in combination with pembrolizumab and chemotherapy drugs such as carboplatin or cisplatin.

Multiple visits per cycle for infusions and assessments

Follow-up

Duration - Up to approximately 4 years

Participants are monitored for safety and long-term effectiveness after treatment ends.

Periodic visits for assessments

Trial Site Locations

Total: 27 locations

1

Stanford Medicine Cancer Center

Stanford, California, United States, 94305

Actively Recruiting

2

Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute

Orlando, Florida, United States, 32827

Actively Recruiting

3

Florida Cancer Specialists - Sarasota

Sarasota, Florida, United States, 34236

Actively Recruiting

4

The University of Chicago Medical Center (UCMC)

Chicago, Illinois, United States, 60637

Actively Recruiting

5

Community Health Network

Indianapolis, Indiana, United States, 46250

Not Yet Recruiting

6

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

7

Washington University

St Louis, Missouri, United States, 63110

Actively Recruiting

8

John Theurer Cancer Center At Hackensack UMC

Hackensack, New Jersey, United States, 07601

Actively Recruiting

9

Columbia University

New York, New York, United States, 10032

Actively Recruiting

10

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Actively Recruiting

11

The Ohio State University (OSU) Wexner Medical Center

Columbus, Ohio, United States, 43210

Actively Recruiting

12

Sarah Cannon Research Institute

Nashville, Tennessee, United States, 37203

Actively Recruiting

13

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

14

START Mountain Region

West Valley City, Utah, United States, 84119

Actively Recruiting

15

NEXT Virginia

Fairfax, Virginia, United States, 22031

Actively Recruiting

16

West China Hospital, Sichuan University

Chengdu, China, 610041

Not Yet Recruiting

17

Shanghai East Hospital, Tongji University

Shanghai, China, 0200120

Not Yet Recruiting

18

Tongji Hospital of Tongji Medical College, Huazhong University of Science & Technology

Wuhan, China, 430030

Not Yet Recruiting

19

Centre Leon Berard

Lyon, France, 69373

Actively Recruiting

20

Institut Gustave Roussy

Villejuif, France, 94805

Actively Recruiting

21

Kyoto University Hospital

Kyoto, Japan, 606-8507

Actively Recruiting

22

National Cancer Center Hospital

Tokyo, Japan, 104-0045

Actively Recruiting

23

Cancer Institute Hospital of JFCR

Tokyo, Japan, 135-8550

Actively Recruiting

24

Severance Hospital, Yonsei University Health System

Seoul, South Korea, 03722

Actively Recruiting

25

Samsung Medical Center

Seoul, South Korea, 06351

Actively Recruiting

26

Hospital Universitario Vall d'Hebron

Barcelona, Spain, 08035

Actively Recruiting

27

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Actively Recruiting

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Research Team

T

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

P

Physicians interested in becoming principal investigators please contact

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

5

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