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ACTIVE NOT RECRUITING Phase 2

A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer

NCT05382442 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 254 participants
Start Date 2022-06-27
Est. Completion 2028-08-12
Phase Phase 2

Sponsor

Akeso

31 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05382442

The ClinicalTrials.gov registry entry for NCT05382442 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 254 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Akeso, which has 31 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05382442 reports 4 study locations spanning 3 distinct geographic areas — top geographies include California, Virginia, Guangdong. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05382442?

The interventions under investigation include: Capecitabine (DRUG), Oxaliplatin (DRUG), AK117 (DRUG), Irinotecan (DRUG), AK112 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05382442?

This trial is sponsored by Akeso, which has 31 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial