LY3143921 / Eli Lilly - LARVOL DELTA

CRUKD/17/004: A CR-UK Phase I Trial of LY3143921 (clinicaltrials.gov) - P1 | N=69 | Active, not recruiting | Sponsor: Cancer Research UK | Trial completion date: Jul 2023 ➔ Feb 2027 | Trial primary completion date: Jul 2023 ➔ Feb 2027

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Esophageal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatology • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Triple Negative Breast Cancer • Urothelial Cancer • TP53

A CRUK first-in-human phase I trial of LY3143921, a novel CDC7 inhibitor, in patients with advanced solid tumors. (ASCO 2022) - P1 | "LY3143921 is well tolerated, exhibits dose-dependent increases in plasma exposure and demonstrates evidence of target inhibition. Significant monotherapy clinical activity was not observed; further analyses should investigate potential predictive response biomarkers and rational combination approaches."

Clinical • P1 data • Anorexia • Colorectal Cancer • Fatigue • Gastrointestinal Cancer • Hypotension • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor • CDC7 • TP53

CRUKD/17/004: A CR-UK Phase I Trial of LY3143921 (clinicaltrials.gov) - P1 | N=69 | Active, not recruiting | Sponsor: Cancer Research UK | Recruiting ➔ Active, not recruiting | N=115 ➔ 69 | Trial completion date: Jan 2022 ➔ Jul 2023 | Trial primary completion date: Jan 2022 ➔ Jul 2023

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Esophageal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatology • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Triple Negative Breast Cancer • Urothelial Cancer • TP53

[VIRTUAL] Pharmacokinetics of the CDC7 inhibitor LY3143921 hydrate, a CRUK first-in-human phase I trial in patients with advanced solid tumors (AACR-II 2020) - "The pharmacokinetic data generated to date are consistent with dose dependent increases in drug exposure observed with a flat dosing regimen for LY3143921 hydrate."

Clinical • P1 data • PK/PD data • Oncology • Solid Tumor

A CRUK first-in-human phase I trial of a CDC7 Inhibitor, LY3143921 hydrate, in patients with advanced solid tumors. (ASCO 2019) - P1; "Evaluation of potential predictive and pharmacodynamic biomarkers including p53 mutations, phosphorylated MCM2, cyclin B1 and molecular subgroups of target tumours will be included. Clinical trial information: NCT03096054"

Clinical • P1 data

A CR-UK Phase I Trial of LY3143921 (clinicaltrials.gov) - P1; N=115; Recruiting; Sponsor: Cancer Research UK; N=68 ➔ 115

Clinical • Enrollment change • Breast Cancer • Colorectal Cancer • Esophageal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatology • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Triple Negative Breast Cancer • Urothelial Cancer • TP53

A CR-UK Phase I Trial of LY3143921 (clinicaltrials.gov) - P1; N=68; Recruiting; Sponsor: Cancer Research UK; Trial completion date: Nov 2020 ➔ Jan 2022; Trial primary completion date: Nov 2020 ➔ Jan 2022

Clinical • Trial completion date • Trial primary completion date • Bladder Cancer • Breast Cancer • Colorectal Cancer • Esophageal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Thoracic Cancer • Urothelial Cancer