Clinical Trials List
2025-02-20 - 2027-10-29
Phase II
Recruiting4
ICD-10C18.9
Malignant neoplasm of colon, unspecified
ICD-10C7A.029
Malignant carcinoid tumor of the large intestine, unspecified portion
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9153.9
Malignant neoplasm of colon, unspecified
Innovative Trial Interventional Therapies and Combinations for Colorectal Cancer: Key Program for Participants
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Trial Applicant
PAREXEL INTERNATIONAL CO., LTD.
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Sponsor
Parexel International Co., Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/08/17
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Inclution Criteria
2. Pathologically confirmed colorectal adenocarcinoma.
3. Formalin-fixed paraffin-embedded (FFPE) tumor specimens provided according to standard of care (SoC).
4. All races, sexes, and ethnicities are eligible to participate in this trial.
5. Measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, and no disease progression within the 4 weeks prior to screening and randomization (i.e., ECOG PS > 1).
7. Life expectancy at screening ≥ 12 weeks.
8. Capable of providing signed informed consent in the manner described and in accordance with the requirements and limitations listed in the ICF.
9. Provide a signed and dated written ICF before proceeding with any necessary trial-specific procedures, specimen collection, and analysis.
10. Provide signed and dated written informed consent for selective genetic research information before collecting specimens to support the genomics project. Participants who do not consent to participate in selective genetic research will still be eligible for the main trial.
Exclusion Criteria
2. Known severe allergy to any monoclonal antibody or test excipient, or any test intervention in chemotherapy.
3. Clinically significant ascites, pleural effusion, or pericardial effusion, defined as any ascites/effusion requiring nonpharmacological intervention (e.g., paracentesis) to maintain symptom control within 6 months prior to the first scheduled dose. Participants are eligible if they have received a stable dose of diuretics for ascites for ≥2 months.
4. Evidence of the following infections:
Active infection, including tuberculosis.
• Uncontrolled human immunodeficiency virus (HIV) infection;
• Co-infection with hepatitis B virus (HBV) and hepatitis D virus (HDV);
• Active or uncontrolled hepatitis B or hepatitis C;
• Known active hepatitis A.
5. Any unresolved toxicity ≥ Grade 2 according to the Common Terminology Criteria for Adverse Events (CTCAE) of previous anticancer therapy, excluding hair loss, vitiligo, and laboratory values defined in the inclusion criteria for individual sub-trials.
6. History of another primary malignancy, excluding:
a) A malignancy that has received curative treatment, has no known active disease for ≥ 2 years prior to the first dose of the trial treatment, and has a low potential risk of recurrence.
b) Non-melanoma skin cancer or malignant lentigo maligna that has been appropriately treated and has no evidence of disease.
c) Carcinoma in situ that has been appropriately treated and has no evidence of disease.
7. Any condition, as determined by the trial administrator, that would interfere with the evaluation of the investigational product (IP), or with participant safety or the interpretation of trial results.
8. A known history of immunodeficiency, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation.
The Estimated Number of Participants
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Taiwan
16 participants
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Global
120 participants
