Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here