Agenda
THURSDAY, SEPTEMBER 11, 2025
9:00 – 9:10 AM | Welcome/Introductions/Housekeeping Items Lorraine Pelosof, Investigational Drug Branch (IDB), Cancer Therapy Evaluation Program (CTEP), National Cancer Institute (NCI) |
CTEP-SPONSORED EARLY-PHASE BET INHIBITOR STUDIES: CLINICAL TRIAL SESSION | |
There will be time for questions after each trial presentation (5-minute discussions) | |
| 9:10 AM – 9:30 AM | Protocol 10507 - A Phase 1/2 Study of the Bromodomain Inhibitor ZEN003694 in Combination with Etoposide/Platinum in Patients with NUT Carcinoma (Jia Luo; Dana-Farber Cancer Institute) |
| 9:30 AM – 9:50 AM | Protocol 10509: A Phase 1 Study of BET Bromodomain Inhibitor ZEN003694 in Combination with the CDK4/6 Inhibitor Abemaciclib in Patients with NUT Carcinoma and Other Solid Tumors (Jia Luo; Dana-Farber Cancer Institute) |
| 9:50 AM – 10:10 AM | Protocol 10579: Phase I Trial of ZEN003694 (ZEN-3694) in Combination with Capecitabine in Patients with Solid Tumors (Dennis Hsu; University of Pittsburgh Medical Center) |
| 10:10 AM– 10:30 AM | Protocol 10605 - A Phase 1 Study of ZEN003694 (ZEN-3694) in Combination with Cetuximab and Encorafenib in Patients with Refractory BRAF V600E Metastatic Colorectal Cancer (Alonso Martinez; MD Anderson Cancer Center) |
| 10:30 AM– 10:50 AM | Protocol 10499 - Phase Ib/II Study of ZEN003694 and Entinostat in Advanced and Refractory Solid Tumors and Lymphomas (Pat LoRusso (or So Yeon); Yale Cancer Center) |
| 10:50 AM-11:00 AM | Discussion |
| 11:00 AM – 11:45 AM | RoadMap to Reducing Animal Testing in Preclinical Safety Studies (Jibran Ahmed, National Cancer Institute) |
| 11:45 AM – 1:00 PM | LUNCH BREAK |
Rare Tumor Educational Session | |
| 1:00 PM – 1:15 PM | Protocol 10066: A Phase 1/2 Study of Olaparib in Combination with Ramucirumab in Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma (Michael Cecchini, Yale Cancer Center) |
| 1:15 PM – 1:30 PM | Protocol 10450: A Phase 1b Trial of M3814 (Peposertib) in Combination with Lutetium 177 Dotatate for Well-Differentiated Somatostatin Receptor-Positive Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) (Aman Chauhan; University of Miami and Brian Anthony Lowell; University of Kentucky) |
| 1:30 PM – 1:45 PM | Protocol 10592: A Randomized Phase 2 Study of ATR Inhibition in Advanced PD-(L)1-Refractory Merkel Cell Carcinoma: The MATRiX Trial (Evan Hall; Fred Hutchinson) |
| 1:45 PM – 2:00 PM | Protocol 10603: A Phase 2 Study of M1774 in Refractory SPOP-Mutant Prostate Cancer (Jacob Orme; Mayo Clinic) |
| 2:00 PM – 2:15 PM | Discussion |
| 2:15 PM – 2:30 PM | BREAK |
CTEP Immuno-Oncology Early-Phase Trial Session | |
There will be time for questions after each trial presentation (5-minute discussions) | |
| 2:30 PM – 2:50 PM | Protocol 10556: Randomized Phase 2 Study of Cabozantinib, Ipilimumab, and Nivolumab in Patients with Soft Tissue Sarcoma (Alice Chen; National Cancer Institute) |
| 2:50 PM – 3:10 PM | Protocol 10080: Phase I Study of Recombinant Interleukin 15 in Combination with Checkpoint Inhibitors Nivolumab and Ipilimumab in Subjects with Refractory Cancers (Jibran Ahmed, National Cancer Institute) |
| 3:10 PM- 3:30 PM | Protocol 10508: A Phase 1 Study of Nivolumab in Combination with ASTX727 in B-cell lymphoma (NHL or HL) with an Expansion Cohort in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (Catherine Diefenbach, NYU Langone) |
| 3:30 PM – 3:50 PM | Protocol 10433: Phase I/Ib Trial Evaluating the Safety and Efficacy of BET Inhibitor, ZEN003694 with PD-1 Inhibitor, Nivolumab with or Without CTLA-4 Inhibitor, Ipilimumab in Solid Tumors (Haider Mahdi; University of Pittsburgh Medical Center) |
| 3:50 PM – 4:00 PM | Discussion |
| 4:00 PM | ADJOURN DAY 1 |
FRIDAY, SEPTEMBER 12, 2025
CTEP-Sponsored Early-Phase: Targeted Clinical Trial Session | |
| 9:00 AM – 9:10 AM | Welcome/Introductions Lorraine Pelosof, Investigational Drug Branch (IDB), Cancer Therapy Evaluation Program (CTEP), National Cancer Institute (NCI) |
| 9:10 AM– 9:25 AM | Protocol 10401: A Phase 0 window-of-opportunity pharmacodynamic trial of triapine (NSC# 663249) in uterine corpus serous adenocarcinoma (Rebecca Stone; Johns Hopkins University) |
| 9:25 AM– 9:40 AM | Protocol 10276: A Phase I/II Study of M3814 and Avelumab in Combination with Hypofractionated Radiation in Patients with Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies (Kristen Spencer, NYU Langone) |
| 9:40 AM - 10:00 AM | Protocol 10434: Randomized Phase 2 Study of Daunorubicin and Cytarabine Liposome + Pomalidomide Versus Daunorubicin and Cytarabine Liposome in Newly Diagnosed AML with MDS-Related Changes (Joshua Zeidner; University of North Carolina) |
| 10:00 AM -10:15 AM | Protocol 10273: A Phase 1 Study of M3814 in combination with MEC in Patients with Relapsed or Refractory Acute Myeloid Leukemia (Brian Jonas; UC Davis Comprehensive Cancer Center) |
| 10:15 AM – 10:30 AM | Protocol 10302: Phase II Trial of Radium-223 Dichloride in Combination with Paclitaxel in Patients with Bone Metastatic Breast Cancer (Jyoti Malhotra; City of Hope) |
| 10:30 AM – 10:45 AM | Discussion |
| 10:45 AM – 11:00 AM | BREAK |
Nineteenth Annual Michaele C. Christian Oncology Drug Development Award & Lecture | |
| 11:00 AM – 11:05 AM | Introduction Steve Gore, Investigational Drug Branch, CTEP, NCI |
| 11:05 AM-11:15 AM | Presentation of Award Michaele C. Christian IDB, CTEP, NCI |
| 11:15 AM – 12:00 PM | Awardee Lecture |
| 12:00 PM | Adjourn |