Leronlimab in Combination With Regorafenib in Patients With CCR5+, Metastatic Colorectal Cancer
NCT05730673 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2023-02-17
Summary
This is aPhase II Study of Leronlimab (PRO 140) in combination with Regorafenib in Patients with CCR5+, Microsatellite Stable (MSS), Metastatic Colorectal Cancer (mCRC)
Conditions
- CCR5
- Microsatellite Stable
- Metastatic
- Colorectal Cancer
Interventions
- DRUG
-
700mg leronlimab weekly dose
leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5
- DRUG
-
80mg Regorafenib at week 1
Regorafenib is a small-molecule multiple kinase inhibitor
- DRUG
-
120mg Regorafenib at week2
Regorafenib is a small-molecule multiple kinase inhibitor
- DRUG
-
160 mg Regorafenib at week 3
Regorafenib is a small-molecule multiple kinase inhibitor
Sponsors & Collaborators
-
Amarex Clinical Research
collaborator OTHER -
CytoDyn, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-09-20
- Primary Completion
- 2023-05-27
- Completion
- 2023-08-10
- FDA Drug
- Yes
More Related Trials
-
A Phase 2 Randomized, Open-Label Study of RRx-001 vs Regorafenib in Subjects With Metastatic Colorectal Cancer
NCT02096354 ·Status: COMPLETED ·Phase: PHASE2
-
Lower or Standard Dose Regorafenib in Treating Patients With Refractory Metastatic Colorectal Cancer
NCT02368886 ·Status: COMPLETED ·Phase: PHASE2
-
Regorafenib in Metastatic Colorectal Cancer
NCT02466009 ·Status: COMPLETED ·Phase: PHASE2
-
Combination of LTC004 and Regorafenib to Treat Patients With Advanced/Metastatic CRC
NCT06322563 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A Trial of Regorafenib Plus Lorigerlimab as Neoadjuvant Therapy for Patients With pMMR/MSS, Resectable, Lung-limited Metastatic Colorectal Cancer
NCT07137390 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
A Real-World Study to Learn More About the Order of Different Treatments and Their Effects in People With Metastatic Colorectal Cancer Receiving Their Third and Fourth Line of Treatment
NCT06137170 ·Status: COMPLETED
-
A Trial of Regorafenib Plus Lorigerlimab in Patients With Locally Recurrent or Regrowing pMMR/MSS Localized Rectal Cancer
NCT07223567 ·Status: WITHDRAWN ·Phase: PHASE2
-
Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer
NCT00838578 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Efficacy and the Safety of Regorafenib in Patients Aged More Than 70 Years With a Metastatic Colorectal Adenocarcinoma .
NCT02788006 ·Status: COMPLETED ·Phase: PHASE2
-
An Observational Study to Learn More About the Long-Term Responses to Treatment With Regorafenib in Patients With Metastatic Colorectal Cancer in the United States
NCT06029010 ·Status: COMPLETED
-
Regorafenib in Frail and/or Unfit for Chemotherapy Patients With Metastatic Colorectal Cancer
NCT01875380 ·Status: COMPLETED ·Phase: PHASE2
-
GSL Synthetase Inhibitor Plus Immune Checkpoint Inhibitor and/or Regorafenib in Previously Treated pMMR/MSS CRC.
NCT06558773 ·Status: RECRUITING ·Phase: PHASE2
-
Study on the Effectiveness and Safety of the Combination of the Two Drugs Regorafenib and Nivolumab in Patients With Colorectal Cancer (Cancer of the Colon or Rectum Classified as Proficient Mismatch Repair and Microsatellite Stable)
NCT04126733 ·Status: COMPLETED ·Phase: PHASE2
-
Regorafenib in Reducing Recurrence in Patients With Non-metastatic Rectal Cancer Who Have Completed Curative-Intent Treatment
NCT02287727 ·Status: WITHDRAWN ·Phase: PHASE2
-
Study to Determine the Efficacy of Regorafenib in Metastatic Colorectal Cancer Patients and to Discover Biomarkers
NCT01949194 ·Status: UNKNOWN ·Phase: PHASE2
-
Regorafenib and Pembrolizumab in Treating Participants With Advanced or Metastatic Colorectal Cancer
NCT03657641 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
A Biomarker Study in Patients Getting Regorafenib for Metastatic Colorectal Cancer
NCT02402036 ·Status: TERMINATED ·Phase: PHASE2
-
Asian Subjects With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy
NCT01584830 ·Status: COMPLETED ·Phase: PHASE3
-
Regorafenib and Nivolumab in Mismatch Repair (MMR) Refractory Colorectal Cancer
NCT03712943 ·Status: COMPLETED ·Phase: PHASE1
-
Toripalimab,Celecoxib and Regorafenib in the Treatment of Refractory Advanced Colorectal Cancer
NCT05933980 ·Status: RECRUITING ·Phase: PHASE2
-
Safety Study of Regorafenib and SIR-Spheres® Microspheres Radioembolization in Patients With Refractory Metastatic Colorectal Cancer With Liver Metastases
NCT02195011 ·Status: COMPLETED ·Phase: PHASE2
-
Regorafenib + Panitumumab for Colorectal Cancers
NCT02199223 ·Status: TERMINATED ·Phase: PHASE1
-
A Study to Evaluate the Safety and Efficacy of Selinexor With or Without Pembrolizumab Versus Standard of Care in Previously Treated Metastatic Colorectal Cancer With RAS Mutations
NCT04854434 ·Status: TERMINATED ·Phase: PHASE2
-
Regorafenib Combined With Irinotecan as Second-line in Patients With Metastatic Gastro-oesophageal Adenocarcinomas
NCT03722108 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Regorafenib (Reg) and Lorigerlimab (Lor), RELO Regimen, in Treatment of High-risk Patients With Colorectal Cancer With Radiographic Occult Molecular Residual Disease After End of Established Definitive Therapy [ReLOAD Trial]
NCT07071961 ·Status: SUSPENDED ·Phase: PHASE2