Phase 2 Study of CA102N Combined With TAS-102 Compared to Bevacizumab Combined With TAS-102 in Subjects With Relapsed and/or Refractory Metastatic Colorectal Cancer
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ClinicalTrials.gov Identifier: NCT06039202 |
Recruitment Status :
Not yet recruiting
First Posted : September 15, 2023
Last Update Posted : September 15, 2023
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Tracking Information | |||||||
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First Submitted Date ICMJE | September 1, 2023 | ||||||
First Posted Date ICMJE | September 15, 2023 | ||||||
Last Update Posted Date | September 15, 2023 | ||||||
Estimated Study Start Date ICMJE | January 2024 | ||||||
Estimated Primary Completion Date | February 2025 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | No Changes Posted | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Phase 2 Study of CA102N Combined With TAS-102 Compared to Bevacizumab Combined With TAS-102 in Subjects With Relapsed and/or Refractory Metastatic Colorectal Cancer | ||||||
Official Title ICMJE | A Phase 2, Randomized, Open Label Study to Evaluate Efficacy, Safety, and Tolerability of CA102N Combined With Trifluridine/Tipiracil (TAS-102) Compared to Bevacizumab Combined With TAS-102 in Subjects With Metastatic Colorectal Cancer (mCRC) Who Failed the Standard Treatment | ||||||
Brief Summary | HS-CA102N-103 is a Phase 2, randomized, open label study to evaluate efficacy, safety, and tolerability of CA102N combined with trifluridine/tipiracil (TAS-102) compared to bevacizumab combined with TAS-102 in subjects with metastatic colorectal cancer (mCRC) who failed the standard treatment (for eg, cancer that has relapsed after or is refractory to fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy). | ||||||
Detailed Description | HS-CA102N-103 is a Phase 2, randomized, open label study to evaluate efficacy, safety, and tolerability of CA102N combined with trifluridine/tipiracil (TAS-102) compared to bevacizumab combined with TAS-102 in subjects with metastatic colorectal cancer (mCRC) who failed the standard treatment (for eg, cancer that has relapsed after or is refractory to fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy). In this study, the safety, tolerability, and PFS of CA102N in combination with TAS-102 compared to bevacizumab combined with TAS-102 will be evaluated in up to 100 subjects with metastatic colorectal cancer who have previously received fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor (VEGF) biological therapy, and if RAS wild-type mCRC, an anti-epidermal growth factor receptor (EGFR) therapy. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Up to 100 subjects will be enrolled in this study (including drop-out subjects), with 50 subjects assigned to each treatment arm. For arm 1, subjects will receive the assigned dose level of CA102N in combination with trifluridine/tipiracil (TAS-102). For Arm 2, subjects will receive bevacizumab in combination with trifluridine/tipiracil (TAS-102) Primary Purpose: Treatment |
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Condition ICMJE | Metastatic Colorectal Cancer | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Pant S, Dragovich T, Lieu C, Jimeno A, Kundranda M, Menter D, Tchaparian E, Chen YC, Kopetz S. Phase 1 study of the safety, pharmacokinetics, and preliminary efficacy of CA102N as monotherapy and in combination with trifluridine-tipiracil in patients with locally advanced or metastatic solid tumors. Invest New Drugs. 2023 Feb;41(1):25-34. doi: 10.1007/s10637-022-01308-5. Epub 2022 Nov 4. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||
Estimated Enrollment ICMJE |
100 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | October 2025 | ||||||
Estimated Primary Completion Date | February 2025 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Not Provided | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT06039202 | ||||||
Other Study ID Numbers ICMJE | HS-CA102N-103 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Holy Stone Healthcare Co., Ltd | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Holy Stone Healthcare Co., Ltd | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE | Not Provided | ||||||
PRS Account | Holy Stone Healthcare Co., Ltd | ||||||
Verification Date | September 2023 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |