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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
Sponsor:
Information provided by (Responsible Party):
Holy Stone Healthcare Co., Ltd

Study Description
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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).

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: CA102N Drug: TAS-102 Biological: Bevacizumab Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : January 2024
Estimated Primary Completion Date : February 2025
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CA102N plus Trifluridine/tipiracil (TAS-102)
CA102N administered as 0.72 mg/kg of nimesulide equivalents on Days 1 and 15 of each 28-day cycle in combination with TAS-102 at 35 mg/m2/dose orally twice daily (BID) on Days 1 through 5 and Days 8 through 12 of each 28-day cycle. Administration sequence will be CA102N then TAS-102 (IV then oral)
 Drug: CA102N
CA102N is a covalently bound conjugate of the biological polymer sodium hyaluronate (NaHA) and nimesulide (Nim)
Other Name: Nim-HA cinjugate

Drug: TAS-102
TAS-102 is a cytotoxic combination treatment of 2 drugs: trifluridine, a thymidine-based nucleoside analogue, and tipiracil an inhibitor of thymidine phosphorylase.
Other Name: Trifluridine/tipiracil
Active Comparator: Bevacizumab plus Trifluridine/tipiracil (TAS-102)
bevacizumab 5 mg/kg on Days 1 and 15 of each 28-day cycle in combination with 35 mg/m2 of TAS-102 orally twice daily (BID) on Days 1 through 5 and Days 8 through 12 of each 28-day cycle. Administration sequence will be bevacizumab then TAS-102 (IV then oral)
 Drug: TAS-102
TAS-102 is a cytotoxic combination treatment of 2 drugs: trifluridine, a thymidine-based nucleoside analogue, and tipiracil an inhibitor of thymidine phosphorylase.
Other Name: Trifluridine/tipiracil

Biological: Bevacizumab
Bevacizumab recombinant humanized monoclonal antibody that binds and neutralizes circulating vascular endothelial growth factor (VEGF)-A.


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the efficacy of CA102N in combination with trifluridine/tipiracil (TAS-102) by progression free survival (PFS) rate. [ Time Frame: 16 weeks after first treatment. ]
  2. Number of subjects with treatment-related adverse events as assessed by NCI-CTCAE v5.0 [ Time Frame: one year after first treatment. ]

Secondary Outcome Measures :
  1. Disease control rate (DCR) [ Time Frame: 16 weeks after first treatment. ]
    To evaluate the efficacy of CA102N in combination with trifluridine/tipiracil (TAS-102) by disease control rate.

  2. Overall response rate (ORR) [ Time Frame: 16 weeks after first treatment. ]
    To evaluate the efficacy of CA102N in combination with trifluridine/tipiracil (TAS-102) by overall response rate.

  3. Maximum Plasma Concentration [Cmax] of CA102N when used in combination with trifluridine/tipiracil (TAS-102) [ Time Frame: 16 weeks after first treatment. ]
  4. To evaluate the efficacy of CA102N in combination with trifluridine/tipiracil (TAS-102) by overall survival (OS). [ Time Frame: one year after first treatment. ]

Other Outcome Measures:
  1. Protein expression level of pharmacodynamic biomarkers [ Time Frame: 16 weeks after first treatment. ]
  2. Quality of life measured by European Organization for the research and treatment of cancer quality of life questionnaire (EORTC QLQ-C30). [ Time Frame: one year after first treatment. ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults aged ≥20 years in Taiwan, and Korea, or those aged ≥18 years in the US, at the time the ICFs are signed. (Please follow local regulatory requirements if the legal age of consent for study participation is different).
  • Have relapsed after, intolerant to, or are refractory to fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.
  • Eastern Cooperative Oncology Group performance status 0 to 1.
  • Presence of at least one measurable lesion (minimum 10 mm) assessed by the Investigator per RECIST version 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions after the end of radiotherapy.
  • Has a life expectancy of ≥3 months.
  • Women of childbearing potential and men with partners of childbearing potential must agree to use a highly effective means of contraception from study entry through at least 6 months after the last dose of CA102N.

Exclusion Criteria:

  • History of hypersensitivity or hepatotoxic reactions to nimesulide or to any excipient.
  • History or presence of a bleeding tendency or disorder.
  • History of gastrointestinal bleed or perforation related to previous nonsteroidal anti-inflammatory drugs (NSAIDs) or bevacizumab.
  • Presence or history of recurrent peptic ulcer or hemorrhage (2 or more distinct episodes of proven ulceration or bleeding).
  • History of cerebrovascular or other active bleeding.
  • Myocardial infarction within the last 12 months prior to the first dose of study drug, severe/unstable angina, symptomatic congestive heart failure New York Heart Association Class III or IV.
  • History of a serious cardiac arrhythmia requiring treatment. Subjects whose arrhythmia is well-controlled (eg, by ablation or medical therapy) may be considered for enrollment after discussion with the study medical monitor.
  • Has had clinically significant lung disease (eg, interstitial pneumonia, interstitial lung disease, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) requiring continuous systemic corticosteroid treatment for 6 months before Screening or who are suspected to have such diseases by imaging at Screening.
  • Ascites, pleural effusion, or pericardial fluid requiring drainage in last 4 weeks prior to Screening, or subject who continues to have a peritoneal/pleural/pericardial drainage catheter post-surgery at the time of informed consent signature.
  • History of allogeneic transplantation requiring immunosuppressive therapy.
  • Presence of uncontrolled infections.
  • Known positive test for hepatitis B, hepatitis C or human immunodeficiency virus. Testing is not required for protocol eligibility. Subjects who have received curative therapy for HCV with no detectable viral load are not excluded.
  • Has clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with steroids and stable brain metastases at least 3 months may be included in the study if they have recovered from the acute toxic effect of radiotherapy.
  • Pregnant or breast feeding or intends to become pregnant during the study.
  • Unresolved toxicity of greater than or equal to NCI-CTCAE (version 5.0) Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation, and platinum-induced peripheral neurotoxicity).
  • Has a concomitant medical condition that would increase the risk of toxicity or confine the interpretation of efficacy or safety in the opinion of the Investigator.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06039202


Contacts
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Contact: Ivy Chen 886 2 87975966 ext 272 ivychen@hshc.com.tw

Sponsors and Collaborators
Holy Stone Healthcare Co., Ltd
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Holy Stone Healthcare Co., Ltd
ClinicalTrials.gov Identifier: NCT06039202    
Other Study ID Numbers: HS-CA102N-103
First Posted: September 15, 2023    Key Record Dates
Last Update Posted: September 15, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Trifluridine
 Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents