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| ID | Type | Description | Link |
|---|---|---|---|
| J6D-MC-JSDA | Other Identifier | Eli Lilly and Company | |
| 2025-521916-20-00 | EU Trial (CTIS) Number |
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The purpose of this study is to measure the safety and efficacy of LY4175408 in participants with selected advanced cancer. In addition, this 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. Participation could last up to 4 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1a Dose Escalation (Cohort A1) | Experimental | Escalating doses of LY4175408 administered intravenously (IV) |
|
| Phase 1a Dose Optimization (Cohort A2) | Experimental | Two or more doses of LY4175408 (evaluated during dose escalation) administered IV |
|
| Phase 1b Dose Expansion (Cohort B1) | Experimental | LY4175408 administered IV followed by pembrolizumab administered IV |
|
| Phase 1b Dose Expansion (Cohort B2) | Experimental | LY4175408 administered IV followed by pembrolizumab administered IV and either carboplatin administered IV or cisplatin administered IV |
|
| Phase 1b Dose Expansion (Cohorts C1, C2 and C3) | Experimental | LY4175408 administered IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY4175408 | Drug | IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1a-Number of Participants with Dose Limiting Toxicities of LY4175408 | 1 Cycle (21 days) | |
| Phase 1b-Overall Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR) | Per investigator assessed Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) | Baseline up to approximately 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1a and 1b-Pharmacokinetics (PK): Minimum Plasma Concentration (Cmin) of LY4175408 (total antibody, conjugated antibody, free payload) | First 4 cycles (84 days) | |
| Phase 1a and 1b-PK: Area under the Concentration versus Time Curve (AUC) of LY4175408 (total antibody, conjugated antibody, free payload) |
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Inclusion Criteria:
Have one of the following advanced or metastatic solid tumor cancers:
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 Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| 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) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Medicine Cancer Center | Recruiting | Stanford | California | 94305 | United States | |
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| Label | URL |
|---|---|
| A Study of LY4175408 in Participants With Advanced Cancer | View source |
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| Pembrolizumab | Drug | IV infusion |
|
| Carboplatin | Drug | IV infusion |
|
| Cisplatin | Drug | IV infusion |
|
| First 4 cycles (84 days) |
| Phase 1a-ORR: Percentage of Participants with Best Response of CR or PR | Per investigator assessed RECIST 1.1 | Baseline up to approximately 4 years |
| Phase 1a and 1b-Time to Response (TTR) | Per investigator assessed RECIST 1.1 | Baseline up to approximately 4 years |
| Phase 1a and 1b-Progression-free Survival (PFS) | Per investigator assessed RECIST 1.1 | Baseline up to approximately 4 years |
| Phase 1a and 1b-Disease Control Rate (DCR) | Per investigator assessed RECIST 1.1 | Baseline up to approximately 4 years |
| Phase 1a and 1b-Duration of Response (DOR) | Per investigator assessed RECIST 1.1 | Baseline up to approximately 4 years |
| Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute |
| Recruiting |
| Orlando |
| Florida |
| 32827 |
| United States |
| Florida Cancer Specialists - Sarasota | Recruiting | Sarasota | Florida | 34236 | United States |
| The University of Chicago Medical Center (UCMC) | Recruiting | Chicago | Illinois | 60637 | United States |
| Community Health Network | Recruiting | Indianapolis | Indiana | 46250 | United States |
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| Washington University | Recruiting | St Louis | Missouri | 63110 | United States |
| John Theurer Cancer Center At Hackensack UMC | Recruiting | Hackensack | New Jersey | 07601 | United States |
| Columbia University | Recruiting | New York | New York | 10032 | United States |
| David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
| The Ohio State University (OSU) Wexner Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
| Sarah Cannon Research Institute | Recruiting | Nashville | Tennessee | 37203 | United States |
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| START Mountain Region | Recruiting | West Valley City | Utah | 84119 | United States |
| NEXT Virginia | Recruiting | Fairfax | Virginia | 22031 | United States |
| West China Hospital, Sichuan University | Not yet recruiting | Chengdu | 610041 | China |
| Shanghai East Hospital, Tongji University | Not yet recruiting | Shanghai | 0200120 | China |
| Tongji Hospital - Tongji Medical College of HUST | Not yet recruiting | Wuhan | 430030 | China |
| Centre Leon Berard | Recruiting | Lyon | 69373 | France |
| Institut Gustave Roussy | Recruiting | Villejuif | 94805 | France |
| Kyoto University Hospital | Recruiting | Kyoto | 606-8507 | Japan |
| National Cancer Center Hospital | Recruiting | Tokyo | 104-0045 | Japan |
| Cancer Institute Hospital of JFCR | Recruiting | Tokyo | 135-8550 | Japan |
| Severance Hospital, Yonsei University Health System | Recruiting | Seoul | 03722 | South Korea |
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
| Hospital Universitario Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| D016889 | Endometrial Neoplasms |
| D009362 | Neoplasm Metastasis |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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