Neuroendocrine Neoplasm Clinical Trial
Official title:
A Phase 1b Trial of M3814 (Peposertib) in Combination With Lutetium 177 Dotatate for Well-Differentiated Somatostatin Receptor-Positive Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)
This phase Ib trial is to find out the best dose, possible benefits and/or side effects of peposertib when given together with lutetium Lu 177 dotatate in treating patients with neuroendocrine tumors. Peposertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell formation, so as to help block the formation of growths that may become cancer. Radioactive drugs, such as lutetium Lu 177 dotatate, may deliver radiation directly to tumor cells and not harm normal cells. Adding peposertib to lutetium Lu 177 dotatate may kill more tumor cells.
PRIMARY OBJECTIVE: I. To evaluate the safety and to determine the recommended phase 2 dose (RP2D) of lutetium Lu 177 dotatate in combination with M3814 (peposertib). SECONDARY OBJECTIVES: I. To observe and record anti-tumor activity. II. To determine the overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at 4, 8, and 12 months post-therapy. III. To measure duration of response (DOR) associated with the combination. IV. To evaluate progression-free survival (PFS). CORRELATIVE OBJECTIVES: I. Measure the somatostatin receptor uptake on gallium 68 dotatate or Copper 64 dotatate at baseline. II. Perform lutetium Lu 177 dotatate dosimetry. III. Determine the pharmacokinetic (PK) parameters of M3814 (peposertib). IV. Describe the tumor molecular profile using whole exome sequencing (WES) and ribonucleic acid (RNA) sequencing (RNAseq) and correlate it with treatment outcome. V. Collect plasma for circulating tumor deoxyribonucleic acid (DNA) (ctDNA) assessment. VI. Collect blood for biobanking and future correlative studies. VII. Measure association of overall response rate with gallium 68 dotatate-positron emission tomography (PET)/computed tomography (CT) or Copper 64 dotatate measurements and Krenning score. OUTLINE: This is a dose-escalation study of peposertib followed by a dose-expansion study. Patients receive peposertib orally (PO) once daily (QD) or twice daily (BID) on days 1-21 and lutetium Lu 177 dotatate intravenously (IV) over 30 minutes on day 1. Treatment repeats every 56 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT/magnetic resonance imaging (MRI) throughout the trial and undergo collection of blood samples on study. After completion of study treatment, patients are followed up every 4 months for 24 months. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04464122 -
Rediscovering Biomarkers for the Diagnosis and Early Treatment Response in NEN (REBORN)
|
||
| Active, not recruiting |
NCT03375320 -
Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors
|
Phase 3 | |
| Active, not recruiting |
NCT03980925 -
Platinum-doublet Chemotherapy and Nivolumab for the Treatment of Subjects With Neuroendocrine Neoplasms (NENs) of the Gastroenteropancreatic (GEP) Tract or of Unknown (UK) Origin.
|
Phase 2 | |
| Recruiting |
NCT02402244 -
Project: Every Child for Younger Patients With Cancer
|
||
| Recruiting |
NCT05113355 -
Chidamide Plus Sintilimab for Chemotherapy-refractory Advanced High-grade Neuroendocrine Neoplasm
|
Phase 2 | |
| Recruiting |
NCT05879055 -
A Study of PM8002 Injection in Combination With Chemotherapy in Patients With NEN
|
Phase 2 | |
| Terminated |
NCT03001349 -
68Ga-DOTA-TOC PET/CT in Imaging Participants With Neuroendocrine Tumors
|
Early Phase 1 | |
| Completed |
NCT02399215 -
Nintedanib in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors
|
Phase 2 | |
| Recruiting |
NCT05165407 -
Sintilimab Combined With IBI310 and Surufatinib for the Treatment of G3-NET and NEC
|
Phase 2 | |
| Recruiting |
NCT06337760 -
YOUNg Adults With Gastro-inteSTinal (GI) and nEuroendocrine canceRs.
|
||
| Recruiting |
NCT04927611 -
Single-cell Sequencing and Establishment of Models in Neuroendocrine Neoplasm
|
||
| Active, not recruiting |
NCT01638533 -
Romidepsin in Treating Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Solid Tumors With Liver Dysfunction
|
Phase 1 | |
| Recruiting |
NCT02817945 -
Dual SSTR2 and Integrin αvβ3 Targeting PET/CT Imaging
|
Early Phase 1 | |
| Active, not recruiting |
NCT03950609 -
Lenvatinib and Everolimus in Treating Patients With Advanced, Unresectable Carcinoid Tumors
|
Phase 2 | |
| Active, not recruiting |
NCT02402920 -
Pembrolizumab and Concurrent Chemoradiotherapy or Radiation Therapy in Treating Patients With Small Cell Lung Cancer
|
Phase 1 | |
| Not yet recruiting |
NCT04931446 -
Neuroendocrine Neoplasm Based on Multi-omics Integrated Analysis
|
||
| Recruiting |
NCT06343428 -
Definition of a Multiparametric Prognostic and Predictive System of Classification of NET G3 Patients
|
||
| Recruiting |
NCT04720391 -
Bone Metastases in neurOendocrine NEoplasms: naTural History, Prognostic Impact and Therapeutic Approach (MONET)
|
||
| Recruiting |
NCT03734913 -
A Phase 1 Study of ZSP1602 in Participants With Advanced Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT03511768 -
A Study of 18F-AlF-NOTA-octreotide PET/CT for Imaging Neuroendocrine Neoplasms
|
Phase 1/Phase 2 |