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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-511238-11-00 | EU Trial (CTIS) Number | ||
| J5E-OX-JZXA | Other Identifier | Eli Lilly and Company | |
| LOXO-FRA-24001 | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to find out whether the study drug, LY4170156, is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY4170156 (Dose-escalation, Cohort A1) | Experimental | Escalating doses of LY4170156 administered intravenously (IV) |
|
| LY4170156 (Cohort A1 Parts A and C) | Experimental | LY4170156 administered IV |
|
| LY4170156 Alone or with Itraconazole. Drug-Drug Interaction (DDI) (Cohort A1: Arm B) | Experimental | LY4170156 administered IV and itraconazole administered orally |
|
| LY4170156 (Dose-optimization, Cohort A2) | Experimental | Comparing 2 or more doses (evaluated during dose escalation) of LY4170156 administered IV |
|
| LY4170156 (Enrichment Cohort A3) | Experimental | Monotherapy administered IV |
|
| LY4170156 (Combination Cohort A4) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY4170156 | Drug | Intravenous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1a: To determine the recommended phase 2 dose (RP2D) of LY4170156 | Number of participants with dose-limiting toxicities (DLTs) | 1 Cycle (21 days) |
| Phase 1a: To determine the RP2D or optimal dose of LY4170156 with bevacizumab | Number of participants with DLTs | 1 Cycle (21 days) |
| Phase 1a: To determine the RP2D or optimal dose of LY4170156 with carboplatin | Number of participants with DLTs | 1 Cycle (21 days) |
| Phase 1a: To determine the RP2D or optimal dose of LY4170156 with pembrolizumab | Number of participants with DLTs | 1 Cycle (21 days) |
| Phase 1b: To assess the antitumor activity of LY4170156 Monotherapy: Overall response rate (ORR) | ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) | Up to Approximately 48 Months or 4 Years |
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module | Up to Approximately 48 Months or 4 Years |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the pharmacokinetics (PK) properties of LY4170156: Minimum Plasma Concentration (Cmin) | PK: Cmin of LY4170156 | First 4 Cycles (84 days) |
| To characterize the PK properties of LY4170156: Cmin with bevacizumab or carboplatin |
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Inclusion Criteria:
Have one of the following solid tumor cancers:
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 |
|---|---|---|---|---|---|---|
| HonorHealth | Recruiting | Scottsdale | Arizona | 85258 | United States | |
| University of California, San Diego (UCSD) - Moores Cancer Center |
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| Label | URL |
|---|---|
| A Study of LY4170156 in Participants With Selected Advanced Solid Tumors | View source |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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Combination with bevacizumab administered IV
|
| LY4170156 (Combination Cohort A5) | Experimental | Combination with carboplatin administered IV |
|
| LY4170156 Combination with Pembrolizumab (Dose-optimization Cohort A6) | Experimental | Comparing 2 or more doses (evaluated during dose escalation) of LY4170156 administered IV with pembrolizumab |
|
| LY4170156 (Dose-expansion, Cohort B1-B4) | Experimental | LY4170156 administered IV |
|
|
| bevacizumab | Drug | IV |
|
| carboplatin | Drug | IV |
|
| Itraconazole | Drug | oral |
|
| pembrolizumab | Drug | IV |
|
PK: Cmin of LY4170156
| First 4 Cycles (Approximately 84 days) |
| To characterize the PK properties of LY4170156: Cmin with pembrolizumab | PK: Cmin of LY4170156 | First 4 Cycles (84 days) |
| To characterize the PK properties of LY4170156: Area under the concentration versus time curve (AUC) | PK: AUC of LY4170156 | First 4 Cycles (84 days) |
| To evaluate the preliminary antitumor activity of LY4170156: Overall response rate (ORR) | ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) | Up to Approximately 48 Months or 4 Years |
| To evaluate the preliminary antitumor activity of LY4170156: Overall response rate (ORR) with bevacizumab or carboplatin or pembrolizumab | ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) | Up to Approximately 48 Months or 4 Years |
| To evaluate the preliminary antitumor activity of LY4170156: Duration of response (DOR) | DOR per investigator assessed RECIST 1.1 | Up to Approximately 48 Months or 4 Years |
| To evaluate the preliminary antitumor activity of LY4170156: Duration of response (DOR) with bevacizumab or carboplatin or pembrolizumab | DOR per investigator assessed RECIST 1.1 | Up to Approximately 48 Months or 4 Years |
| To evaluate the preliminary antitumor activity of LY4170156: Time to response (TTR) | TTR per investigator assessed RECIST 1.1 | Up to Approximately 48 Months or 4 Years |
| To evaluate the preliminary antitumor activity of LY4170156: Time to response (TTR) with bevacizumab or carboplatin or pembrolizumab | TTR per investigator assessed RECIST 1.1 | Up to Approximately 48 Months or 4 Years |
| To evaluate the preliminary antitumor activity of LY4170156: Progression free survival (PFS) | PFS per investigator assessed RECIST 1.1 | Up to Approximately 48 Months or 4 Years |
| To evaluate the preliminary antitumor activity of LY4170156: Progression free survival (PFS) with bevacizumab or carboplatin or pembrolizumab | PFS per investigator assessed RECIST 1.1 | Up to Approximately 48 Months or 4 Years] |
| To evaluate the preliminary antitumor activity of LY4170156: Disease control rate (DCR) | DCR per investigator assessed RECIST 1.1 | Up to Approximately 48 Months or 4 Years |
| To evaluate the preliminary antitumor activity of LY4170156: Disease control rate (DCR) with bevacizumab or carboplatin or pembrolizumab | DCR per investigator assessed RECIST 1.1 | Up to Approximately 48 Months or 4 Years |
| Recruiting |
| La Jolla |
| California |
| 92037 |
| United States |
| South Texas Accelerated Research Therapeutics (START) Midwest | Recruiting | Grand Rapids | Michigan | 49546 | United States |
| NYU Langone Health - Long Island | Recruiting | Mineola | New York | 11501 | United States |
| New York University (NYU) Clinical Cancer Center | Recruiting | New York | New York | 10016 | 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 |
| The University of Texas - MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030-4000 | United States |
| START Mountain Region | Recruiting | West Valley City | Utah | 84119 | United States |
| Cancer Research SA | Recruiting | Adelaide | 5000 | Australia |
| Icon Cancer Centre South Brisbane | Recruiting | QLD | 4101 | Australia |
| Centre Leon Berard | Recruiting | Lyon | 69373 | France |
| Institut de Cancerologie de l'Ouest - site St-Herblain | Recruiting | Saint-Herblain | 44805 | France |
| Oncopole Claudius Regaud | Recruiting | Toulouse | 31059 | France |
| Humanitas San Pio X | Recruiting | Milan | 20159 | Italy |
| Istituto Europeo di Oncologia | Recruiting | Milan | 20141 | Italy |
| Shizuoka Cancer Center | Recruiting | Shizuoka | 411-8777 | Japan |
| National Cancer Center Hospital | Recruiting | Tokyo | 104-0045 | Japan |
| Cancer Institute Hospital of JFCR | Recruiting | Tokyo | 135-8550 | Japan |
| National Cancer Center | Recruiting | Goyang-si Gyeonggi-do | 10408 | South Korea |
| Hospital Universitario Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
| Hospital Clinico Universitario de Valencia | Recruiting | Valencia | 46010 | Spain |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D016889 | Endometrial Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D064726 | Triple Negative Breast Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D015179 | Colorectal Neoplasms |
| D008175 | Lung Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
| D002577 | Uterine Cervical Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D016190 | Carboplatin |
| D017964 | Itraconazole |
| C582435 | pembrolizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
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