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A Study of LY4175408 for Advanced Cancers

This study is testing a new drug called LY4175408 for people with advanced cancers, including non-small cell lung cancer, small cell lung cancer, endometrial cancer, and triple negative breast cancer. Researchers want to see how safe and effective LY4175408 is, sometimes given with other treatments like Pembrolizumab, Carboplatin, or Cisplatin. They will also study how your body handles LY4175408. The study will measure how many participants experience serious side effects and how many see their tumors shrink or disappear. You may be eligible if you have one of the listed advanced cancers, and for triple negative breast cancer, your tumor must be HER2-negative. The study is currently recruiting participants.

Study design
This study is an interventional study with a planned enrollment of 240 participants. It is testing different drug interventions including LY4175408, Pembrolizumab, Carboplatin, and Cisplatin.
What's involved
Participation in this study could last up to approximately 4 years. The study will evaluate how much LY4175408 gets into the bloodstream, how it is broken down, and how long it takes the body to get rid of it.
Compensation
Not stated in the trial record.
Follow-up
The study will measure overall response rate from baseline up to approximately 4 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07046923

A Study of LY4175408 in Participants With Advanced Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
Eli Lilly and Company
~240 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:LY4175408PembrolizumabCarboplatinCisplatin

At a glance

Recruiting sites
24 of 27 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1a-Number of Participants with Dose Limiting Toxicities of LY4175408
Measured over 1 Cycle (21 days)
+1 more outcome measured

Conditions

Carcinoma, Non-Small-Cell Lung
Small Cell Lung Carcinoma
Endometrial Neoplasms
Neoplasm Metastasis
Triple Negative Breast Cancer

Explore related trials

Breast CarcinomaEndometrial NeoplasmLung Non-Small Cell CarcinomaLung Small Cell Carcinoma

Where it's being run

27 sites across 18 states
China3
Japan3
Florida2
New York2
France2
South Korea2
Spain2
California1

Study leadership

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Have one of the following advanced or metastatic solid tumor cancers:
Non-small cell lung cancer (NSCLC)
Small cell lung cancer (SCLC)
Endometrial cancer
Triple negative breast cancer (TNBC) (characterized by HR-negative disease and HER2-negative expression according to American Society of Clinical Oncology (ASCO) - College of American Pathologists guidelines).
Received all standard therapies for which the individual was deemed to be an appropriate candidate by the treating investigator (except in Cohort B1 and B2 expansion, which require participants who are treatment naive in the advanced metastatic setting); OR the individual is refusing the remaining most appropriate standard of care treatment; OR there is no standard therapy available for the disease.
Eastern Cooperative Oncology Group (ECOG) performance status of greater than or equal to (≤) 1.
For dose optimization/dose and expansion cohorts (Cohort A2, Cohort B/C): Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Cohorts B1/B2: NSCLC with no known actionable genomic alterations. ≤2 prior lines of systemic therapy for advanced or metastatic disease in safety lead-in; no prior systemic therapy in expansion

Exclusion

Prior treatment with a protein tyrosine kinase 7 (PTK7) antibody-drug conjugate (ADC) with a topoisomerase I inhibitor as payload (prior therapy with a PTK7 ADC with a non-topoisomerase I inhibitor payload OR non-PTK7 ADC with any payload is permitted). Prior topoisomerase I-based ADCs are not allowed in cohorts A2, B1 or B2.
Any serious unresolved toxicities from prior therapy.
Individual with known or suspected history of uncontrolled central nervous system (CNS) metastases.
Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection.
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 the trial or within 30 days of the last dose of trial intervention.

What this trial measures

  • Phase 1a-Number of Participants with Dose Limiting Toxicities of LY41754081 Cycle (21 days)
  • Phase 1b-Overall Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR)Baseline up to approximately 4 years

    Per investigator assessed Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)