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A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04929223
Recruitment Status : Recruiting
First Posted : June 18, 2021
Last Update Posted : August 1, 2022
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This open-label, exploratory study is designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Inavolisib Drug: Bevacizumab Drug: Cetuximab Drug: Atezolizumab Drug: Tiragolumab Drug: SY-5609 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : October 22, 2021
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Inavolisib + Cetuximab

Participants will receive 9 milligrams (mg) of inavolisib by mouth once daily (QD) on Days 8-28 of Cycle 1, then QD on Days 1-28 from Cycle 2 onwards (1 cycle=28 days).

Participants will also receive cetuximab intravenous (IV) infusion 400 mg/m2 body surface area on Day 1 of Cycle 1. All subsequent weekly (QW) doses will be 250 mg/m2 each.

Drug: Inavolisib
Inavolisib will be administered orally as per schedule specified in the respective arms.

Drug: Cetuximab
Cetuximab IV will be administered as per specified in the respective arm.

Experimental: Inavolisib + Bevacizumab
Participants will receive 9 mg of inavolisib by mouth QD combined with bevacizumab 15 milligram/kilogram (mg/kg) IV once every three weeks (Q3W) on Day 1 of each cycle (1 cycle=21 days).
Drug: Inavolisib
Inavolisib will be administered orally as per schedule specified in the respective arms.

Drug: Bevacizumab
Bevacizumab IV will be administered as per specified in the respective arm.
Other Name: Avastin

Experimental: Atezolizumab + Tiragolumab + Bevacizumab
Participants will receive 1200 mg of atezolizumab by IV infusion on Day 1 of each cycle, combined with Tiragolumab at a dose of 600 mg IV infusion on Day 1 of each cycle and Bevacizumab IV infusion at a dose of 15 mg/kg on Day 1 of each cycle. (Cycle length=21 days)
Drug: Bevacizumab
Bevacizumab IV will be administered as per specified in the respective arm.
Other Name: Avastin

Drug: Atezolizumab
Atezolizumab IV infusion will be administered as per specified in the respective arm.
Other Name: Tecentriq

Drug: Tiragolumab
Tiragolumab IV infusion will be administered as per specified in the respective arm.

Experimental: Atezolizumab + Tiragolumab
Participants will receive 1200 mg of atezolizumab by IV infusion on Day 1 of each cycle combined with tiragolumab 600 mg IV infusion on Day 1 of each cycle. (Cycle length=21 days)
Drug: Atezolizumab
Atezolizumab IV infusion will be administered as per specified in the respective arm.
Other Name: Tecentriq

Drug: Tiragolumab
Tiragolumab IV infusion will be administered as per specified in the respective arm.

Experimental: Atezolizumab + SY-5609
Participants will receive 1680 mg of atezolizumab by IV infusion on Day 1 of each cycle Q4W in repeated 28-day cycles combined with SY-5609 at a dose of 3, 4, or 5 mg by mouth for 7 days, followed by 7 days off. (Cycle length=28 days)
Drug: Atezolizumab
Atezolizumab IV infusion will be administered as per specified in the respective arm.
Other Name: Tecentriq

Drug: SY-5609
SY-5609 will be administered by mouth as per specified in the respective arm.




Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: Approximately 36 months ]
    Defined as the proportion of patients with a complete response or partial response, as determined by the investigator according to RECIST v1.1


Secondary Outcome Measures :
  1. Duration of Response [ Time Frame: Approximately 36 months ]
    Defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1

  2. Disease Control Rate [ Time Frame: Approximately 36 months ]
    Defined as the proportion of patients with stable disease, or a complete or partial response, as determined by the investigator according to RECIST v1.1

  3. Percentage of Participants with Adverse Events (AEs) [ Time Frame: Approximately 36 months ]
    Percentage of participants with adverse events.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

  • Signed next-generation sequencing (NGS) Biomarker Eligibility 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)
  • Availability of an archival tissue sample for exploratory biomarker research
  • Adequate hematologic and organ function within 14 days prior to initiation of study treatment
  • For women of childbearing potential: Must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment and agreement to remain abstinent or use contraceptive measures
  • For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm

Exclusion Criteria

  • Current participation or enrollment in another interventional clinical trial
  • 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
  • Known HIV infection
  • 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

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): NCT04929223


Contacts
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Contact: Reference Study ID Number: WO42758 https://forpatients.roche.com/ 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
Show Show 35 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04929223    
Other Study ID Numbers: WO42758
First Posted: June 18, 2021    Key Record Dates
Last Update Posted: August 1, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: 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
Bevacizumab
Cetuximab
Atezolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors