Clinical Trials List
Protocol NumberWO42758
NCT Number(ClinicalTrials.gov Identfier)NCT04929223
Active
2023-03-01 - 2027-12-31
Others
Not yet recruiting3
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
A Phase I/Ib Global, Multicenter, Open-label Umbrella Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
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Trial Applicant
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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
- Yi-Ping Hung Division of Hematology & Oncology
- 姜乃榕 Division of Hematology & Oncology
- Chien-An Liu Division of Hematology & Oncology
- Chueh-Chuan Yen Division of Hematology & Oncology
- Ming-Huang Chen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Peng-Chan Lin Division of Hematology & Oncology
- Jui-Hung Tsai Division of Hematology & Oncology
- Po-Wen Lin Division of General Surgery
- 黃盈慈 Division of Hematology & Oncology
- 陳柏全 Division of General Surgery
- Shang-Hung Chen Division of Hematology & Oncology
- 蘇勇曄 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Metastatic Colorectal Cancer
Objectives
This trial will evaluate the efficacy and safety of multiple therapies selected using somatic variants and potential predictive biomarkers in patients with metastatic colorectal cancer (mCRC).
(For details, please refer to this pilot plan and the Chinese summary of the project)
Test Drug
AtezolizumabTiragolumabInavolisibBevacizumabRO7435846(GDC-6036)CetuximabFluorouracilfolinic acid(Calcium Folinate)OxaliplatinIrinotecan
Active Ingredient
Atezolizumab
Tiragolumab
Inavolisib
Bevacizumab
RO7435846(GDC-6036)
Cetuximab
Fluorouracil
folinic acid(Calcium Folinate)
Oxaliplatin
Irinotecan
Tiragolumab
Inavolisib
Bevacizumab
RO7435846(GDC-6036)
Cetuximab
Fluorouracil
folinic acid(Calcium Folinate)
Oxaliplatin
Irinotecan
Dosage Form
IV
IV
Tablet
IV
Tablet
IV
IV
IV
IV
IV
IV
Tablet
IV
Tablet
IV
IV
IV
IV
IV
Dosage
1200mg/20ml
600mg/10ml
3mg/tablet；9mg/tablet
400mg/16ml
25mg/tablet ; 100mg/tablet ; 200mg/tablet
100mg/20ml
1000mg/20ml
100mg/10ml
100mg/20ml
100mg/5ml
600mg/10ml
3mg/tablet；9mg/tablet
400mg/16ml
25mg/tablet ; 100mg/tablet ; 200mg/tablet
100mg/20ml
1000mg/20ml
100mg/10ml
100mg/20ml
100mg/5ml
Endpoints
‧Inavo + Cetux treatment group: To evaluate the efficacy of combined use of inavolisib and cetuximab in CRC with PIK3CA mutations and undetected RAS (KRAS, NRAS) or BRAFV600E mutations
‧Inavo + Bev treatment group: To evaluate the efficacy of inavolisib combined with bevacizumab in CRC with PIK3CA mutations and RAS (KRAS, NRAS) mutations
‧Atezo + Tira + Bev and Atezo + Tira treatment groups: To evaluate the efficacy of atezolizumab in combination with tiragolumab, with or without bevacizumab, in MSI-H CRC
‧Atezo + SY-5609 treatment group: To evaluate the efficacy of atezolizumab and SY-5609 combined in CRC with BRAFV600E mutation
‧GDC-6036 + Cetux + FOLFOX treatment group: To evaluate the efficacy of GDC-6036 combined with cetuximab and FOLFOX in CRC with KRAS G12C mutation
‧GDC-6036 + Cetux treatment group: To evaluate the efficacy of GDC-6036 combined with cetuximab in CRC with KRAS G12C mutation
(For details, please refer to this pilot plan and the Chinese summary of the project)
‧Inavo + Bev treatment group: To evaluate the efficacy of inavolisib combined with bevacizumab in CRC with PIK3CA mutations and RAS (KRAS, NRAS) mutations
‧Atezo + Tira + Bev and Atezo + Tira treatment groups: To evaluate the efficacy of atezolizumab in combination with tiragolumab, with or without bevacizumab, in MSI-H CRC
‧Atezo + SY-5609 treatment group: To evaluate the efficacy of atezolizumab and SY-5609 combined in CRC with BRAFV600E mutation
‧GDC-6036 + Cetux + FOLFOX treatment group: To evaluate the efficacy of GDC-6036 combined with cetuximab and FOLFOX in CRC with KRAS G12C mutation
‧GDC-6036 + Cetux treatment group: To evaluate the efficacy of GDC-6036 combined with cetuximab in CRC with KRAS G12C mutation
(For details, please refer to this pilot plan and the Chinese summary of the project)
Inclution Criteria
Inclusion Criteria
Signed cohort-specific Informed Consent Form
Age >= 18 years at time of signing Informed Consent Form
Biomarker eligibility as determined at a College of American Pathologists/clinical laboratory improvement amendments (CAP/CLIA)-certified or equivalently accredited diagnostic laboratory using a validated test
Eastern Cooperative Oncology Group (ECOG) Performance Status of <= 1
Life expectancy >= 3 months, as determined by the investigator
Histologically confirmed adenocarcinoma originating from the colon or rectum
Metastatic disease
Prior therapies for metastatic disease
Ability to comply with the study protocol, in the investigators judgment
Measurable disease (at least one target lesion) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Baseline tumor tissue samples will be collected from all patients for exploratory biomarker research
Adequate hematologic and organ function within 14 days prior to initiation of study treatment
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures
For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm
Signed cohort-specific Informed Consent Form
Age >= 18 years at time of signing Informed Consent Form
Biomarker eligibility as determined at a College of American Pathologists/clinical laboratory improvement amendments (CAP/CLIA)-certified or equivalently accredited diagnostic laboratory using a validated test
Eastern Cooperative Oncology Group (ECOG) Performance Status of <= 1
Life expectancy >= 3 months, as determined by the investigator
Histologically confirmed adenocarcinoma originating from the colon or rectum
Metastatic disease
Prior therapies for metastatic disease
Ability to comply with the study protocol, in the investigators judgment
Measurable disease (at least one target lesion) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Baseline tumor tissue samples will be collected from all patients for exploratory biomarker research
Adequate hematologic and organ function within 14 days prior to initiation of study treatment
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures
For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm
Exclusion Criteria
Exclusion Criteria
Current participation or enrollment in another interventional clinical trial. Patients who are participating in the follow-up period of an interventional clinical trial are eligible for the study.
Any systemic anti-cancer treatment within 2 weeks or 5 half-lives (whichever is shorter) prior to start of study treatment
Treatment with investigational therapy within 28 days prior to initiation of study treatment
Pregnant or breastfeeding, or intending to become pregnant during the study
History of or concurrent serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study or confounds the ability to interpret data from the study
Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety
Incomplete recovery from any surgery prior to the start of study treatment that would interfere with the determination of safety or efficacy of study treatment
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
Uncontrolled tumor-related pain
Uncontrolled or symptomatic hypercalcemia
Clinically significant and active liver disease
Negative HIV test at screening, with the following exception: Patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4 count greater than or equal to 200/uL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months.
Symptomatic, untreated, or actively progressing CNS metastases
History of leptomeningeal disease or carcinomatous meningitis
History of malignancy other than CRC within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
Any other disease, unresolved toxicity from prior therapy, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
Requirement for treatment with any medicinal product that contraindicates the use of any of the study treatments, may interfere with the planned treatment, affects patient compliance, or puts the patient at higher risk for treatment-related complications
Current participation or enrollment in another interventional clinical trial. Patients who are participating in the follow-up period of an interventional clinical trial are eligible for the study.
Any systemic anti-cancer treatment within 2 weeks or 5 half-lives (whichever is shorter) prior to start of study treatment
Treatment with investigational therapy within 28 days prior to initiation of study treatment
Pregnant or breastfeeding, or intending to become pregnant during the study
History of or concurrent serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study or confounds the ability to interpret data from the study
Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety
Incomplete recovery from any surgery prior to the start of study treatment that would interfere with the determination of safety or efficacy of study treatment
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
Uncontrolled tumor-related pain
Uncontrolled or symptomatic hypercalcemia
Clinically significant and active liver disease
Negative HIV test at screening, with the following exception: Patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4 count greater than or equal to 200/uL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months.
Symptomatic, untreated, or actively progressing CNS metastases
History of leptomeningeal disease or carcinomatous meningitis
History of malignancy other than CRC within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
Any other disease, unresolved toxicity from prior therapy, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
Requirement for treatment with any medicinal product that contraindicates the use of any of the study treatments, may interfere with the planned treatment, affects patient compliance, or puts the patient at higher risk for treatment-related complications
The Estimated Number of Participants
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Taiwan
30 participants
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Global
422 participants
