Health Trials

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

ConditionMetastatic Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHoffmann-La Roche

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed cohort-specific Informed Consent Form

Age >= 18 years at time of signing Informed Consent Form

A validated test approved by local health authorities for detection of the specified biomarkers/mutations.

A validated test performed at a College of American Pathologists/clinical laboratory improvement amendments (CAP/CLIA) -certified or equivalently accredited diagnostic laboratory using a validated test for detection of the specified biomarkers.

Disqualifiers

Current participation or enrollment in another interventional clinical trial. Participants 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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Inavolisib

    Drug

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

  • Bevacizumab

    Drug

    Bevacizumab IV will be administered as per schedule specified in the respective arm.

  • Cetuximab

    Drug

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

  • Atezolizumab

    Drug

    Atezolizumab IV infusion will be administered as per schedule specified in the respective arm.

  • Tiragolumab

    Drug

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

  • SY-5609

    Drug

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

  • Divarasib

    Drug

    Divarasib will be administered orally as per schedule specified in the respective arms.

  • FOLFOX

    Drug

    FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) IV will be administered as per schedule specified in the respective arm.

  • FOLFIRI

    Drug

    FOLFIRI (leucovorin, 5-fluorouracil, irinotecan) IV will be administered as per schedule specified in the respective arm.

  • FoundationOne®Liquid CDx

    Diagnostic test

    FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment.

Treatment groups

542 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: Inavolisib + CetuximabExperimental treatment 3 interventions
Group B: Inavolisib + BevacizumabExperimental treatment 3 interventions
Group C: Atezolizumab + Tiragolumab + BevacizumabExperimental treatment 4 interventions
Group D: Atezolizumab + TiragolumabExperimental treatment 3 interventions
Group E: Atezolizumab + SY-5609Experimental treatment 3 interventions
Group F: Divarasib + Cetuximab + FOLFOXExperimental treatment 4 interventions
Group G: Divarasib + CetuximabExperimental treatment 3 interventions
Group H: Divarasib + Cetuximab + FOLFIRIExperimental treatment 4 interventions
Group I: Divarasib + Bevacizumab + FOLFOXExperimental treatment 4 interventions
Group J: Divarasib + Bevacizumab + FOLFIRIExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate

Defined as the proportion of participants with a complete response or partial response, as determined by the investigator according to RECIST v1.1

Time frame
Approximately 84 months

Secondary outcomes

1

Duration of Response

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

Time frame
Approximately 84 months
2

Disease Control Rate

Defined as the proportion of participants with stable disease, or a complete or partial response, as determined by the investigator according to RECIST v1.1

Time frame
Approximately 84 months
3

Percentage of Participants with Adverse Events (AEs)

Percentage of participants with adverse events.

Time frame
Approximately 84 months
4

Plasma Concentrations of Divarasib

Plasma concentration of divarasib for divarasib + cetuximab + FOLFOX, divarasib + cetuximab, and divarasib + cetuximab+ FOLFIRI, Divarasib + Bevacizumab + FOLFOX, Divarasib + Bevacizumab + FOLFIRI treatment arms.

Time frame
At pre-defined intervals from first administration of study drug up to approximately 84 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hoffmann-La Roche

Lead sponsor

Source ClinicalTrials.gov
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