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NCT05638295 · ClinicalTrials.gov registry record · Phase 2
Testing the Use of AMG 510 (Sotorasib) and Panitumumab as a Targeted Treatment for KRAS G12C Mutant Solid Tumor Cancers (A ComboMATCH Treatment Trial)
A Phase 2 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 105
- Enrollment target
- 20
- Study locations
NCT05638295: Recruiting Phase 2 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
NCT05638295 is a Phase 2 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 105 participants, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (40% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05638295, a Phase 2 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 105 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II ComboMATCH treatment trial tests how well AMG 510 (sotorasib) with or without panitumumab works in treating patients with KRAS G12C mutant solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Sotorasib is in a class of medications called KRAS inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells. Panitumumab is in a class of medications called monoclonal antibodies. It works by slowing or stopping the growth of cancer cells. Giving combination panitumumab and sotorasib may kill more tumor cells in patients with advanced solid tumors with KRAS G12C mutation.
Primary Outcome
PFS will be compared between the arms using a one-sided log rank test with 10% type I error. Cox's proportional hazards model will be used to estimate the PFS hazard ratio between the treatment arms and a two-sided 80% confidence interval will be reported (to correspond to the one-sided 10% type I error). Confidence intervals on most other quantities will use the two-sided 90% level.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Biopsy Procedure
- BIOLOGICAL Panitumumab
Study Locations (20)
Florida
- UM Sylvester Comprehensive Cancer Center at Aventura - Aventura
- UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
- UM Sylvester Comprehensive Cancer Center at Coral Springs - Coral Springs
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
- UM Sylvester Comprehensive Cancer Center at Hollywood - Hollywood
- Mayo Clinic in Florida - Jacksonville
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- UM Sylvester Comprehensive Cancer Center at Kendall - Miami
- UM Sylvester Comprehensive Cancer Center at Plantation - Plantation
Idaho
- Saint Alphonsus Cancer Care Center-Boise - Boise
- Saint Luke's Cancer Institute - Boise - Boise
- Saint Alphonsus Cancer Care Center-Caldwell - Caldwell
- Kootenai Health - Coeur d'Alene - Coeur d'Alene
- Saint Luke's Cancer Institute - Fruitland - Fruitland
- Saint Luke's Cancer Institute - Meridian - Meridian
California
- The Angeles Clinic and Research Institute - West Los Angeles Office - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- VA Palo Alto Health Care System - Palo Alto
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
- University of South Alabama Mitchell Cancer Institute - Mobile
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2024-08-01 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 2 |
What NCT05638295 shows while recruiting
NCT05638295 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (40% lower).
The record links to 2 conditions, with Advanced Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05638295 names 20 study sites across 4 states, led by Florida, Idaho, California.
Frequently Asked Questions
What is clinical trial NCT05638295 about?
NCT05638295 is a clinical study titled "Testing the Use of AMG 510 (Sotorasib) and Panitumumab as a Targeted Treatment for KRAS G12C Mutant Solid Tumor Cancers (A ComboMATCH Treatment Trial)". This phase II ComboMATCH treatment trial tests how well AMG 510 (sotorasib) with or without panitumumab works in treating patients with KRAS G12C mutant solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Sotorasib is ...
What is the current status of trial NCT05638295?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 2024-08-01. Estimated completion is 2028-12-31.
What conditions does trial NCT05638295 study?
This clinical trial studies the following conditions: Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm.
What interventions are being tested in trial NCT05638295?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Biopsy Procedure (PROCEDURE), Panitumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05638295?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05638295 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Malignant Solid Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05638295's enrollment target sits among peer trials
105 21st of 108 higher than 88 of 108 other Advanced Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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