Metastatic Colorectal Cancer Clinical Trial
Official title:
Phase Ib Study With the Combination of LB-100 (PP2A Inhibitor) and Azenosertib (WEE1 Inhibitor) in Metastatic Colorectal Cancer Patients
This Phase Ib trial studies the side effects and best dose of LB-100 and azenosertib for the treatment of patients with metastatic colorectal cancer. Azenosertib blocks a protein that is involved in the repair of damaged DNA, this protein is called WEE1. Inhibiting WEE1 drives cancer cells into a state of cell division without repair of the damaged DNA, resulting in cell death. LB-100 has been shown to make anticancer drugs work better at killing cancer. LB-100 blocks a protein called PP2A. Blocking this protein increases the stress signals for the tumor cells that express PP2A. Research has shown that azenosertib and LB-100 may enhance each others effect when treating metastatic colorectal cancer.
The goal of this Phase Ib monocenter, open-label, non-randomized clinical trial is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of the combination of LB-100 and azenosertib in patients with metastatic colorectal cancer. This study will consist of a dose escalation phase and a dose expansion phase. The dose escalation phase is designed to find the recommended phase II dose of LB-100 and azenosertib when given together. The dose expansion phase further explores the clinical activity, safety, tolerability and pharmacokinetics/dynamics of LB-100 and azenosertib. Clinical assessments will be performed routinely to monitor safety. Anti-tumor activity will be measured by CT scan according to RECIST version 1.1 criteria. Tumor biopsies will be obtained for exploratory objectives. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01228734 -
A Trial to Compare Oxaliplatin, Folinic Acid (FA) and 5-Fluorouracil (5FU) Combination Chemotherapy (FOLFOX-4) With or Without Cetuximab in the 1st Line Treatment of Metastatic Colorectal Cancer (mCRC) in Chinese Rat Sarcoma Viral Oncogene Homolog (RAS) Wild-type Patients
|
Phase 3 | |
| Completed |
NCT05178745 -
A Prospective Observational Cohort Study Evaluating Resection Rate in Patients With Metastatic Colorectal Cancer Treated With Aflibercept in Combination With FOLFIRI - Observatoire résection
|
||
| Completed |
NCT01591421 -
P13Kinase Inhibitor BKM120 in Combination With Panitumumab in Metastatic/Advanced RAS-Wild Type Colorectal Cancer.
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT05412706 -
Niraparib Maintenance Treatment in mCRC With a Partial o Complete Response After Oxaliplatin-based Induction Therapy
|
Phase 2 | |
| Withdrawn |
NCT04430985 -
FOLFOX + Immunotherapy With Intrahepatic Oxaliplatin for Patients With Metastatic Colorectal Cancer
|
Phase 2 | |
| Withdrawn |
NCT03182894 -
Epacadostat in Combination With Pembrolizumab and Azacitidine in Subjects With Metastatic Colorectal Cancer
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05725200 -
Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer
|
Phase 2 | |
| Terminated |
NCT03176264 -
PDR001 in Combination With Bevacizumab and mFOLFOX6 as First Line Therapy in Patients With Metastatic MSS Colorectal Cancer
|
Phase 1 | |
| Completed |
NCT04866290 -
HepaSphere™ Microspheres Prospective Registry
|
||
| Not yet recruiting |
NCT06425133 -
Regorafenib in Combination With Multimodal Metronomic Chemotherapy for Chemo-resistant Metastatic Colorectal Cancers
|
Phase 2 | |
| Not yet recruiting |
NCT05531045 -
18FFDG PET/CT for Early Evaluation of Chemotherapy Efficacy in Metastatic Colic Adenocarcinoma
|
||
| Withdrawn |
NCT03982173 -
Basket Trial for Combination Therapy With Durvalumab (Anti-PDL1) (MEDI4736) and Tremelimumab (Anti-CTLA4) in Patients With Metastatic Solid Tumors
|
Phase 2 | |
| Completed |
NCT02906059 -
Study of Irinotecan and AZD1775, a Selective Wee 1 Inhibitor, in RAS or BRAF Mutated, Second-line Metastatic Colorectal Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT02575378 -
Maintenance Treatment With Capecitabine Metronomic Chemotherapy and Chinese Traditional Medicine in Metastatic Colorectal Cancer
|
Phase 4 | |
| Withdrawn |
NCT02535988 -
Abscopal Effect for Metastatic Colorectal Cancer
|
Phase 2 | |
| Recruiting |
NCT02848807 -
Chemotherapy-related Toxicity, Nutritional Status and Quality of Life
|
N/A | |
| Active, not recruiting |
NCT02077868 -
Evaluation of MGN1703 Maintenance Treatment in Patients With mCRC With Tumor Reduction During Induction Treatment
|
Phase 3 | |
| Completed |
NCT02414009 -
Study to Compare CAPTEM vs FOLFIRI as Second Line Treatment in Advanced, Colorectal Cancer Patients
|
Phase 2 | |
| Active, not recruiting |
NCT01949194 -
Study to Determine the Efficacy of Regorafenib in Metastatic Colorectal Cancer Patients and to Discover Biomarkers
|
Phase 2 | |
| Withdrawn |
NCT01915472 -
A Phase II Study of IMMU 130 in Patients With Metastatic Colorectal Cancer
|
Phase 2 |