Clinical Trials List
Protocol Number61186372GIC2002
NCT Number(ClinicalTrials.gov Identfier)NCT05379595
Active
2022-07-01 - 2031-04-21
Phase I/II
Recruiting6
ICD-10C18.3
Malignant neoplasm of hepatic flexure
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9153.0
Malignant neoplasm of hepatic flexure colon
A Phase 1b/2, Open-Label Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer
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Trial Applicant
Johnson & Johnson
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 黃文聰 Division of Hematology & Oncology
- Shang-Wen Chen Division of Hematology & Oncology
- 陳威宇 無
- 曹朝榮 Division of Hematology & Oncology
- 陳昭勳 Division of Hematology & Oncology
- 陳冠宇 Division of Hematology & Oncology
- 林建良 Division of Hematology & Oncology
- 高婉真 Division of Hematology & Oncology
- 林正耀 Division of Hematology & Oncology
- 蕭聖諺 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 張境夫 Division of Hematology & Oncology
- Wen-Chi Chou Division of Hematology & Oncology
- 余紹銘 Division of Hematology & Oncology
- Tsai-Sheng Yang Division of Hematology & Oncology
- 黃文冠 Division of Hematology & Oncology
- Jen-Shi Chen Division of Hematology & Oncology
- Mengting Peng Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
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
Condition/Disease
Advanced or Metastatic Colorectal Cancer
Objectives
The objectives of this trial were to evaluate the tumor activity of amivantamab as monotherapy (groups A, B, and C) and to describe the safety of amivantamab when used in combination with standard-of-care chemotherapy in participants with metastatic colorectal cancer (phase 2 cohort).
Test Drug
JNJ-61186372 (Amivantamab)
Active Ingredient
JNJ-61186372 (Amivantamab)
Dosage Form
Solution for infusion
Dosage
50 mg/ml
Endpoints
- Outcome measures: Groups A, B, and C: Overall response rate (ORR)
Time frame: Up to 4 years and 1 month
Note: ORR was defined as the percentage of participants achieving a complete response (CR) or partial response (PR). The degree of response was determined by the trial physician according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Outcome measures: Groups Ph1b-D and Ph1b-E: Number of participants experiencing dose-limiting toxicity (DLT)
Time frame: Up to 4 years and 1 month
Description: The number of participants who will be evaluated for dose-limiting toxicity, which is a specific adverse reaction defined as any of the following events: high-grade non-hematologic toxicity or hematologic toxicity.
- Outcome measures: Groups Ph1b-D and Ph1b-E: Number of participants experiencing dose-limiting toxicity (DLT) by severity
Time frame: Up to 4 years and 1 month
Description: The number of participants who experience dose-limiting toxicity, which is a specific adverse reaction defined as any of the following events: high-grade non-hematologic toxicity or hematologic toxicity, will be assessed by severity. Toxicity will be graded for severity according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Grade 1: mild, grade 2: moderate, grade 3: severe, grade 4: life-threatening, and grade 5: death related to the adverse event.
- Outcome measures: Groups D and E: Number of participants experiencing adverse events
Time frame: Up to 4 years and 1 month
Description: Adverse events refer to any unfavorable medical occurrences that occur to participants during the trial period, which are not necessarily causally related to the drug/biologic in the trial. The severity of adverse events will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. The severity ranges from Grade 1 (mild) to Grade 5 (death). Grade 1: mild, grade 2: moderate, grade 3: severe, grade 4: life-threatening, and grade 5: death related to the adverse event.
- Outcome measures: Groups D and E: Number of participants with abnormal laboratory values
Time frame: Up to 4 years and 1 month
Note: The number of participants with abnormal laboratory values will be reported, including serum chemistry, hematology, coagulation, and urinalysis.
- Outcome measures: Groups D and E: Number of participants with abnormal vital signs
Time frame: Up to 4 years and 1 month
Note: The number of participants with abnormal vital signs including body temperature, heart rate, respiratory rate, blood pressure (systolic and diastolic), and blood oxygen saturation will be reported.
Time frame: Up to 4 years and 1 month
Note: ORR was defined as the percentage of participants achieving a complete response (CR) or partial response (PR). The degree of response was determined by the trial physician according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Outcome measures: Groups Ph1b-D and Ph1b-E: Number of participants experiencing dose-limiting toxicity (DLT)
Time frame: Up to 4 years and 1 month
Description: The number of participants who will be evaluated for dose-limiting toxicity, which is a specific adverse reaction defined as any of the following events: high-grade non-hematologic toxicity or hematologic toxicity.
- Outcome measures: Groups Ph1b-D and Ph1b-E: Number of participants experiencing dose-limiting toxicity (DLT) by severity
Time frame: Up to 4 years and 1 month
Description: The number of participants who experience dose-limiting toxicity, which is a specific adverse reaction defined as any of the following events: high-grade non-hematologic toxicity or hematologic toxicity, will be assessed by severity. Toxicity will be graded for severity according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Grade 1: mild, grade 2: moderate, grade 3: severe, grade 4: life-threatening, and grade 5: death related to the adverse event.
- Outcome measures: Groups D and E: Number of participants experiencing adverse events
Time frame: Up to 4 years and 1 month
Description: Adverse events refer to any unfavorable medical occurrences that occur to participants during the trial period, which are not necessarily causally related to the drug/biologic in the trial. The severity of adverse events will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. The severity ranges from Grade 1 (mild) to Grade 5 (death). Grade 1: mild, grade 2: moderate, grade 3: severe, grade 4: life-threatening, and grade 5: death related to the adverse event.
- Outcome measures: Groups D and E: Number of participants with abnormal laboratory values
Time frame: Up to 4 years and 1 month
Note: The number of participants with abnormal laboratory values will be reported, including serum chemistry, hematology, coagulation, and urinalysis.
- Outcome measures: Groups D and E: Number of participants with abnormal vital signs
Time frame: Up to 4 years and 1 month
Note: The number of participants with abnormal vital signs including body temperature, heart rate, respiratory rate, blood pressure (systolic and diastolic), and blood oxygen saturation will be reported.
Inclution Criteria
Inclusion Criteria:
Participant must have been previously diagnosed with histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum
For Phase 1 dose confirmation cohorts (Cohorts Ph1b-D and Ph1b-E): Participant must have evaluable disease. For Phase 2 dose expansion cohorts (Cohorts D and E): Participant must have measurable disease according to Response Criteria in Solid Tumors (RECIST) Version 1.1. If only one measurable lesion exists, it may be used for the screening biopsy as long as baseline tumor assessment scans are performed greater than or equal to (>=) 7 days after the biopsy
Participant must have Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Participant must have a tumor lesion amenable for biopsy and agree to mandatory protocol-defined screening biopsy
A female participant of childbearing potential must have a negative serum pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study. Note: Participant must not be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study
Participant must have been previously diagnosed with histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum
For Phase 1 dose confirmation cohorts (Cohorts Ph1b-D and Ph1b-E): Participant must have evaluable disease. For Phase 2 dose expansion cohorts (Cohorts D and E): Participant must have measurable disease according to Response Criteria in Solid Tumors (RECIST) Version 1.1. If only one measurable lesion exists, it may be used for the screening biopsy as long as baseline tumor assessment scans are performed greater than or equal to (>=) 7 days after the biopsy
Participant must have Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Participant must have a tumor lesion amenable for biopsy and agree to mandatory protocol-defined screening biopsy
A female participant of childbearing potential must have a negative serum pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study. Note: Participant must not be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study
Exclusion Criteria
Exclusion Criteria:
Participant with identified mutation in Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), v-raf murine sarcoma viral oncogene homolog B (BRAF), or epidermal growth factor receptor (EGFR) ectodomain, or ERBB2/HER2 amplification by central circulating tumor deoxyribonucleic acid (ctDNA) testing at screening
Participant with symptomatic or untreated brain metastasis
History or known presence of leptomeningeal disease
Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
Participant with identified mutation in Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), v-raf murine sarcoma viral oncogene homolog B (BRAF), or epidermal growth factor receptor (EGFR) ectodomain, or ERBB2/HER2 amplification by central circulating tumor deoxyribonucleic acid (ctDNA) testing at screening
Participant with symptomatic or untreated brain metastasis
History or known presence of leptomeningeal disease
Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
The Estimated Number of Participants
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Taiwan
30 participants
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Global
230 participants
