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| ID | Type | Description | Link |
|---|---|---|---|
| J5J-OX-JZZA | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to assess safety & tolerability and antitumor activity of LY3962673 as monotherapy and in combination with other chemotherapy agents in participants with KRAS G12D-mutant advanced solid tumor types. The study is expected to last approximately 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1a: LY3962673 Dose Escalation | Experimental | Escalating doses of LY3962673 administered orally. |
|
| Phase 1b: LY3962673 Dose Expansion | Experimental | LY3962673 administered orally either alone or in combination with other chemotherapy agents. |
|
| Experimental: Phase 1a: LY3962673 Monotherapy | Experimental | LY3962673 administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3962673 | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. | Baseline through 5 years |
| Phase 1a: Number of Participants with DLT | During the first 28-day cycle of LY3962673 treatment | |
| Phase 1a: Number of Participants with DLT Equivalent Toxicities | During the first 28-day cycle of LY3962673 treatment | |
| Phase 1b: Overall Response Rate (ORR) | ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) | Up to approximately 5 years |
| Phase 1b: Best Overall Response (BOR) | BOR per investigator assessed RECIST 1.1 | Up to approximately 5 years |
| Phase 1b: Duration of Response (DOR) | DOR per investigator assessed RECIST 1.1 | Up to approximately 5 years |
| Phase 1b: Time to Response (TTR) | TTR per investigator assessed RECIST 1.1 | Up to approximately 5 years |
| Phase 1b: Disease Control Rate (DCR) |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1a: Overall Response Rate (ORR) | ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) | Up to approximately 5 years |
| Best Overall Response (BOR) |
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Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| City of Hope | Recruiting | Duarte | California | 91010 | United States | |
| University of California, Los Angeles (UCLA) |
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| Label | URL |
|---|---|
| A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors | View source |
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Phase 1a/1b
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| Cetuximab | Drug | Administered intravenously. |
|
| Gemcitabine | Drug | Administered intravenously. |
|
| nab-paclitaxel | Drug | Administered intravenously. |
|
| Oxaliplatin | Drug | Administered intravenously. |
|
| leucovorin | Drug | Administered intravenously. |
|
| Irinotecan | Drug | Administered intravenously. |
|
| 5-fluorouracil | Drug | Administered intravenously. |
|
DCR per investigator assessed RECIST 1.1 |
| Up to approximately 5 years |
BOR per investigator assessed RECIST 1.1
| Up to approximately 5 years |
| Duration of Response (DOR) | DOR per investigator assessed RECIST 1.1 | Up to approximately 5 years |
| Time to Response (TTR) | TTR per investigator assessed RECIST 1.1 | Up to approximately 5 years |
| Disease Control Rate (DCR) | DCR per investigator assessed RECIST 1.1 | Up to approximately 5 years |
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3962673 | PK: Cmax of LY3962673 | Predose through Day 168 |
| PK: Time to Maximum Concentration (Tmax) of LY3962673 | PK: Tmax of LY3962673 | Predose through Day 168 |
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3962673 | PK: AUC of LY3962673 | Predose through Day 168 |
| Recruiting |
| Santa Monica |
| California |
| 90404 |
| United States |
| Sarah Cannon Research Institute at HealthOne | Recruiting | Denver | Colorado | 80218 | United States |
| Sibley Memorial Hospital | Recruiting | Washington D.C. | District of Columbia | 20016 | United States |
| Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute | Recruiting | Orlando | Florida | 32827 | United States |
| Emory University School of Medicine | Recruiting | Atlanta | Georgia | 30322 | United States |
| Community Health Network | Recruiting | Indianapolis | Indiana | 46250 | United States |
| Massachusetts General Hospital | Not yet recruiting | Boston | Massachusetts | 02114 | United States |
| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
| Barbara Ann Karmanos Cancer Institute | Recruiting | Detroit | Michigan | 48201 | United States |
| South Texas Accelerated Research Therapeutics (START) Midwest | Recruiting | Grand Rapids | Michigan | 49546 | United States |
| New York University (NYU) Langone Medical 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 |
| Duke University Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
| University of Cincinnati (UC) - Cancer Institute | Recruiting | Cincinnati | Ohio | 45267 | United States |
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
| University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center | Recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
| Sarah Cannon Research Institute | Recruiting | Nashville | Tennessee | 37203 | United States |
| USO - US Oncology Research Network | Recruiting | Nashville | Tennessee | 37203 | United States |
| Vanderbilt University School of Medicine | Recruiting | Nashville | Tennessee | 37215 | United States |
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| South Texas Accelerated Research Therapeutics (START) | Recruiting | San Antonio | Texas | 78229 | United States |
| Huntsman Cancer Institute | Recruiting | Salt Lake City | Utah | 84112 | United States |
| Fred Hutchinson Cancer Center | Recruiting | Seattle | Washington | 98109 | United States |
| University of Wisconsin - Carbone Cancer Center | Recruiting | Madison | Wisconsin | 53792 | United States |
| The Ottawa Hospital | Recruiting | Ottawa | K1H 8L6 | Canada |
| Princess Margaret Hospital | Recruiting | Toronto | M5G 2M9 | Canada |
| Cancer Institute & Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | Beijing | 100021 | China |
| Beijing Cancer hospital | Not yet recruiting | Beijing | 100142 | China |
| Harbin Medical University Cancer Hospita | Not yet recruiting | Harbin | 150081 | China |
| Fudan University Shanghai Cancer Center | Not yet recruiting | Shanghai | 200032 | China |
| Centre Leon Berard | Not yet recruiting | Lyon | 69373 | France |
| Centre d'Essais Precoces en Cancerologie de Marseille (CEPCM) - AP-HM Hopital de La Timone | Not yet recruiting | Marseille | 13005 | France |
| Oncopole Claudius Regaud | Not yet recruiting | Toulouse | 31059 | France |
| Institut Gustave Roussy | Not yet recruiting | Villejuif | 94805 | France |
| Charite Universitaetsmedizin Berlin | Recruiting | Berlin | 10117 | Germany |
| Universitaetsklinikum Carl Gustav Carus Dresden | Recruiting | Dresden | 01307 | Germany |
| Universitaetsklinikum Essen | Recruiting | Essen | 45147 | Germany |
| Klinikum der Ludwig-Maximilians-Universitaet Muenchen | Recruiting | München | 81377 | Germany |
| START Dublin Early Phase Clinical Trials Unit | Recruiting | Dublin | D07 R2WY | Ireland |
| Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli | Recruiting | Naples | 80138 | Italy |
| UOC Fase I - Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore | Recruiting | Roma | 00168 | Italy |
| Centro Ricerche Cliniche di Verona s.r.l. | Recruiting | Verona | 37134 | Italy |
| National Cancer Center Hospital East | Recruiting | Chiba | 277-8577 | Japan |
| Kanagawa cancer center | Recruiting | Kanagawa | 241-8515 | Japan |
| Aichi Cancer Center Hospital | Recruiting | Nagoya | 464-8681 | Japan |
| Kansai Medical University Hospital | Recruiting | Osaka | 573-1191 | Japan |
| National Cancer Center Hospital | Recruiting | Tokyo | 104-0045 | Japan |
| South Texas Accelerated Research Therapeutics (START) Barcelona- HM Nou Delfos | Recruiting | Barcelona | 08023 | Spain |
| Hospital Universitario Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
| South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz | Recruiting | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D015179 | Colorectal 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 |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| D000093542 | Gemcitabine |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000077150 | Oxaliplatin |
| D002955 | Leucovorin |
| D000077146 | Irinotecan |
| D005472 | Fluorouracil |
| 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 |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
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