Back to resultsIndividual Patient Expanded Access to CA102N
Primary Purpose
Advanced or Metastatic Colorectal Cancer (mCRC)
Status
Temporarily not available
Phase
Locations
Study Type
Expanded Access
Intervention
CA102N
Sponsored by
About this trial
This is an expanded access trial for Advanced or Metastatic Colorectal Cancer (mCRC)
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
-
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT05274204
First Posted
March 2, 2022
Last Updated
February 23, 2023
Sponsor
Holy Stone Healthcare Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05274204
Brief Title
Individual Patient Expanded Access to CA102N
Official Title
Expanded Access to CA102N in One Patient Who Completed at Least 12 Cycles of Combination Therapy of CA102N Plus Lonsurf in Clinical Study Number of HS-CA102N-101
Study Type
Expanded Access
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Temporarily not available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Holy Stone Healthcare Co., Ltd
4. Oversight
5. Study Description
Brief Summary
This study is an individual patient expanded access protocol that the subject enrolled had completed the combination treatment of CA102N plus Lonsurf for at least 12 cycles.
Detailed Description
In the individual patient expanded access, the subject who was enrolled in Phase 1 trial (Study Number: HS-CA102N-101) Part 2 (dose expansion) and had completed at least 12 treatment cycles with CA102N combined with trifluridine /tipiracil (LONSURF) will be provided access to treatment with CA102N (0.72 mg/kg Nimesulide Equivalent of CA102N).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced or Metastatic Colorectal Cancer (mCRC)
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
CA102N
Other Intervention Name(s)
Nim-HA Conjugate
10. Eligibility
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
-
12. IPD Sharing Statement
Learn more about this trial
Individual Patient Expanded Access to CA102N
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