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NCT04185883 · ClinicalTrials.gov registry record · Phase 1
Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)
A Phase 1 study of Advanced Solid Tumors and Kirsten Rat Sarcoma (KRAS) pG12C Mutation, sponsored by Amgen.
- Active
- Registry status
- Phase 1
- Development phase
- 610
- Enrollment target
- 20
- Study locations
NCT04185883: Active Phase 1 study of Advanced Solid Tumors and Kirsten Rat Sarcoma (KRAS) pG12C Mutation, sponsored by Amgen.
NCT04185883 is a Phase 1 study of Advanced Solid Tumors and Kirsten Rat Sarcoma (KRAS) pG12C Mutation that is active but no longer recruiting, run by Amgen. The registered enrollment target is 610 participants, above the 194-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (214% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04185883, a Phase 1 study of Advanced Solid Tumors and Kirsten Rat Sarcoma (KRAS) pG12C Mutation, is active but no longer recruiting, sponsored by Amgen.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 610 participants
- Enrollment target
- 20
- Study locations
Study Summary
To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Trametinib
- DRUG Afatinib
- DRUG Sotorasib
- DRUG RMC-4630
Study Locations (20)
California
- City of Hope National Medical Center - Duarte
- University of California San Diego Moores Cancer Center - La Jolla
- Loma Linda University Cancer Center - Loma Linda
- University of Southern California, Norris Comprehensive Cancer Center - Los Angeles
- University of California Davis Medical Center - Sacramento
- University of California San Francisco Mission Bay Campus - San Francisco
- University of California Los Angeles - Santa Monica
Colorado
- Rocky Mountain Cancer Centers Denver Midtown - Denver
- Sarah Cannon Research Institute - Denver
Connecticut
- Yale New Haven Hospital - New Haven
- Norwalk Hospital - Norwalk
Florida
- Memorial Cancer Institute - Pembroke Pines
- Moffitt Cancer Center - Tampa
Illinois
- Northwestern University - Chicago
- University of Chicago - Chicago
Arizona
- Arizona Oncology Associates Professional Corporation - Tucson
Georgia
- Emory University - Atlanta
Indiana
- Indiana University - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 610 participants |
| Start Date | 2019-12-17 |
| Est. Completion | 2027-12-05 |
| Phase | Phase 1 |
What the registry record for NCT04185883 still lists
NCT04185883 is an interventional study that assigns participants to a tested intervention. The registered 610 participants enrollment target is mid-sized for trials with a published cap, above the 194-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (214% higher).
The record links to 2 conditions, with Advanced Solid Tumors appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04185883 names 20 study sites across 10 states, led by California, Colorado, Connecticut.
Frequently Asked Questions
What is clinical trial NCT04185883 about?
NCT04185883 is a clinical study titled "Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)". To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.
What is the current status of trial NCT04185883?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 610 participants. The study started on 2019-12-17. Estimated completion is 2027-12-05.
What conditions does trial NCT04185883 study?
This clinical trial studies the following conditions: Advanced Solid Tumors, Kirsten Rat Sarcoma (KRAS) pG12C Mutation.
What interventions are being tested in trial NCT04185883?
The interventions under investigation include: Pembrolizumab (DRUG), Trametinib (DRUG), Afatinib (DRUG), Sotorasib (DRUG), RMC-4630 (DRUG).
Who is sponsoring clinical trial NCT04185883?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04185883 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Solid Tumors
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 NCT04185883's enrollment target sits among peer trials
610 6th of 144 higher than 139 of 144 other Advanced Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumors 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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A Study of ASP1570 Taken by Itself, or ASP1570 Taken Together With Either Pembrolizumab, Standard Therapies, or Both, in Adults With Solid Tumors
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Dose Escalation and Expansion Study Evaluating ODC-IL2 in Adult Patients With Advanced or Metastatic Solid Tumors
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JAB-23E73 in Adult Participants With Advanced Solid Tumors With KRAS Alteration
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-
SNV4818 in Participants With Advanced Solid Tumors
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