Agenda
THURSDAY, OCTOBER 8, 2026
| 9:00 – 9:05 AM | Welcome/Introductions/Housekeeping Items Lorraine Pelosof, Investigational Drug Branch (IDB), Cancer Therapy Evaluation Program (CTEP), National Cancer Institute (NCI) |
CTEP-SPONSORED EARLY-PHASE EPIGENETIC STUDIES: CLINICAL TRIAL SESSION | |
| Moderator: Lorraine Pelosof, IDB, CTEP, NCI | |
| There will be time for questions after each trial presentation (5-minute discussions) | |
| 9:05 AM – 9:25 AM | Protocol 10546: Phase I Study Targeting DNA Methyltransferases (ASTX727) in Metastatic Triple-Negative Breast Cancer – Roberto Leon-Ferre (Mayo Clinic – DFCI LAO) |
| 9:25 AM – 9:45 AM | Protocol 10596: A Phase 1b Study of Menin Inhibitor SNDX-5613 in Combination with Daunorubicin and Cytarabine in Newly Diagnosed Patients with Acute Myeloid Leukemia and NPM1 Mutated/FLT3 Wildtype with Higher-Risk Features or MLL/KMT2A Rearranged Disease or NUP98 Alterations Disease – Alice Mims (The Ohio State University) |
| 9:45 AM – 10:05 AM | Protocol 10630: Phase 1 Trial of Iadademstat in Combination with Venetoclax and Azacitidine in Patients with Treatment Naive AML – Annie Im (University of Pittsburgh Cancer Institute) |
| 10:05 AM– 10:25 AM | Protocol 10675: A Randomized Phase 2 Trial of ASTX727 +/- Iadademstat in Accelerated/Blast-Phase Philadelphia Chromosome-Negative Myeloproliferative Neoplasms (MPNs) – Anand Patel (University of Chicago Medical Center) |
| 10:25 AM– 10:45 AM | Protocol 10525: RECORDING A Phase 1b Trial of ZEN003694 (ZEN-3694) with Pembrolizumab and Nab-Paclitaxel in Patients with Metastatic Triple-Negative Breast Cancer – Ana Garrido-Castro (Dana-Farber Cancer Institute) |
| 10:45 AM-10:55 AM | Additional Discussion |
| 10:55 AM – 12:00 PM | Spotlight Presentation: Novel adaptive dose-finding statistical designs, like TALE - Drs. Geoffrey Shapiro (Dana-Farber Cancer Institute), Lorenzo Trippa (Dana-Farber Cancer Institute), and Gregory M. Cote (Mass General Brigham Cancer Institute) |
| 12:00 PM – 1:00 PM | Lunch |
Rare/Rare Subset and Apoptosis Session | |
| Moderators: Lorraine Pelosof and Steve Gore, IDB, CTEP, NCI | |
| 1:00 PM – 1:15 PM | Protocol 10553: A Phase 2 Study of Darolutamide in Combination with Leuprolide Acetate in Hormone-Therapy Naive Recurrent and/or Metastatic Androgen Receptor (AR) Positive Salivary Gland Cancer – Alan Ho (Memorial Sloan Kettering Cancer Center) |
| 1:15 PM – 1:30 PM | Protocol 10597: A Phase 1 Study of APG-1252 (Pelcitoclax) and Cobimetinib in Recurrent Ovarian and Endometrial Cancers – Joyce Liu (Dana-Farber Cancer Institute) |
| 1:30 PM – 1:45 PM | Protocol 10440: A Phase 1/1a Study of Venetoclax, MLN9708 (Ixazomib Citrate) and Dexamethasone for Relapsed/Refractory Light Chain Amyloidosis – Michael Rosenzweig (City of Hope) |
| 1:45 PM – 2:00 PM | Protocol 10670: A Phase 1 Study of 5-Fluorouracil in Combination with Abemaciclib in Metastatic, Refractory CRC – Janie Zhang (University of Pittsburgh Cancer Institute) |
| 2:00 PM-2:15 PM | Protocol 10559: A Phase 2 Study of Erdafitinib in Patients with Recurrent or Progressive IDH-Wild Type Glioma with an FGFR-TACC Gene Fusion – Macarena De La Fuente (University of Miami) |
| 2:15 PM – 2:30PM | Discussion |
| 2:30 PM- 2:40 PM | Break |
CTEP Immuno-Oncology Early-Phase Trial Session | |
| Moderators: Helen Chen, Brian Ko, and Cheryl Pickett, IDB, CTEP, NCI | |
| 2:40 PM - 2:55 PM | Protocol 10601: A Phase 1 Study of Mosunetuzumab with Polatuzumab Vedotin and Lenalidomide (M+Pola+Len) in Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) – Joseph Tuscano (University of California Davis) |
| 2:55 PM - 3:10 PM | Protocol 10614: A Phase 2 Study of Nivolumab and Ipilimumab in Combination with Sirolimus and Prednisone in Kidney Transplant Recipients with Selected Unresectable or Metastatic Cutaneous Cancers – Evan Lipson (Johns Hopkins University) |
| 3:10 PM - 3:25 PM | Protocol 10592: A Randomized Phase 2 Study of ATR Inhibition in Advanced PD-(L)1-Refractory Merkel Cell Carcinoma: The MATRiX Trial – Paul Nghiem or Evan Hall (Fred Hutchinson Cancer Center) |
| 3:25 PM - 3:45 PM | Protocol 10464: A Phase 1 Study of Olaparib in Combination with Durvalumab (MEDI4736) and Concurrent Radiation Therapy Following First-Line Chemotherapy in Locally Advanced Unresectable Pancreatic Cancer – Vaibhav Sahai (University of Michigan) |
| 3:45 PM - 4:00 PM | Discussion |
| 4:00 PM | ADJOURN DAY 1 |
FRIDAY, OCTOBER 9, 2026
CTEP-SPONSORED DNA DAMAGE/REPAIR SESSION | |
| Moderator: Steve Gore, IDB, CTEP, NCI | |
| 9:00 AM – 9:05 AM | Welcome/Introductions Lorraine Pelosof, Investigational Drug Branch (IDB), Cancer Therapy Evaluation Program (CTEP), National Cancer Institute (NCI) |
| There will be time for questions after each trial presentation (5-minute discussions) | |
| 9:05 AM– 9:25 AM | Protocol 10563: A Phase 1 Study of Peposertib (M3814) and Low-Dose Liposomal Doxorubicin in Patients with Metastatic Leiomyosarcoma and Other Soft Tissue Sarcomas – Candace Haddox (Dana-Farber Cancer Center) |
| 9:25 AM– 9:45 AM | Protocol 10572: A Phase 1/2 Trial Evaluating the Combination of Temozolomide and the Ataxia Telangiectasia and Rad3-Related Inhibitor M1774 – Michael Cecchini (Yale Cancer Center) |
| 9:45 AM – 10:05 AM | Protocol 10366: A Phase 1/2 Study of M3814 (Peposertib) in Combination with Hypofractionated Radiotherapy for the Treatment of Locally Advanced Pancreatic Adenocarcinoma – Lindsey Davis (University of Colorado) |
| 10:05 AM -10:25 AM | Protocol 10538: Venetoclax In Combination with ASTX727, an All-ORal TherapY for Chronic Myelomonocytic Leukemia and Other MDS/MPN with Excess Blasts (VICTORY-MDS/MPN): a Randomized, Phase 2 Trial – Rory Shallis (Yale Cancer Center) |
| 10:25 AM – 10:45 AM | Protocol 10558: A Phase II Randomized Control Trial of Triapine Plus Lutetium Lu 177 Dotatate Versus Lutetium Lu 177 Dotatate Alone for Well-Differentiated Somatostatin Receptor-Positive Neuroendocrine Tumors – Aman Chauhan (University of California San Francisco) |
| 10:45 AM – 10:50 AM | Additional Discussion |
| 10:50 AM – 11:05 AM | Break |
TWENTIETH ANNUAL MICHAELE C. CHRISTIAN ONCOLOGY DRUG DEVELOPMENT AWARD & LECTURE | |
| 11:05 AM – 11:10 AM | Introduction Steve Gore, Investigational Drug Branch, CTEP, NCI |
| 11:10 AM-11:20 AM | Presentation of Award Steve Gore, IDB, CTEP, NCI |
| 11:20 AM – 12:00 PM | AWARDEE LECTURE |
| 12:00 PM | ADJOURN |