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NCT05382442 · ClinicalTrials.gov registry record · Phase 2
A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer
A Phase 2 study of Metastatic Colorectal Cancer, sponsored by Akeso.
- Active
- Registry status
- Phase 2
- Development phase
- 254
- Enrollment target
- 4
- Study locations
NCT05382442: Active Phase 2 study of Metastatic Colorectal Cancer, sponsored by Akeso.
NCT05382442 is a Phase 2 study of Metastatic Colorectal Cancer that is active but no longer recruiting, run by Akeso. The registered enrollment target is 254 participants, above the 180-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (41% higher). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05382442, a Phase 2 study of Metastatic Colorectal Cancer, is active but no longer recruiting, sponsored by Akeso.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 254 participants
- Enrollment target
- 4
- Study locations
Study Summary
This trial is a Phase II study. The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of AK112 with or without AK117 in participants with metastatic colorectal cancer who are not suitable for surgery.
Primary Outcome
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG Oxaliplatin
- DRUG AK117
- DRUG Irinotecan
- DRUG AK112
Study Locations (4)
California
- Summit Therapeutics Research Site - Los Angeles
- Summit Therapeutics Research Site - Murrieta
Virginia
- Summit Therapeutics Research Site - Fairfax
Guangdong
- The Sixth Hospital,Sun Yat-sen University - Guanzhou
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 254 participants |
| Start Date | 2022-06-27 |
| Est. Completion | 2028-08-12 |
| Phase | Phase 2 |
What the registry record for NCT05382442 still lists
NCT05382442 is an interventional study that assigns participants to a tested intervention. The registered 254 participants enrollment target is mid-sized for trials with a published cap, above the 180-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (41% higher).
The record links to 1 condition, with Metastatic Colorectal Cancer appearing as the primary indexed condition, and to 5 interventions - of which Capecitabine is the first listed.
NCT05382442 reports a single indexed study location in California, Virginia, Guangdong.
Frequently Asked Questions
What is clinical trial NCT05382442 about?
NCT05382442 is a clinical study titled "A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer". This trial is a Phase II study. The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of AK112 with or without AK117 in participants with metastatic colorectal cancer who are not suitable for surgery.
What is the current status of trial NCT05382442?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 254 participants. The study started on 2022-06-27. Estimated completion is 2028-08-12.
What conditions does trial NCT05382442 study?
This clinical trial studies the following conditions: Metastatic Colorectal Cancer.
What interventions are being tested in trial NCT05382442?
The interventions under investigation include: Capecitabine (DRUG), Oxaliplatin (DRUG), AK117 (DRUG), Irinotecan (DRUG), AK112 (DRUG).
Who is sponsoring clinical trial NCT05382442?
This trial is sponsored by Akeso, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05382442 being conducted?
This trial has 4 study locations across California, Virginia, Guangdong. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT05382442's enrollment target sits among peer trials
254 12th of 45 higher than 34 of 45 other Metastatic Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Colorectal Cancer 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.
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