Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 1interventionalRules rewrite

Phase 1: testing Inavolisib for Metastatic Colorectal Cancer

This open-label, exploratory study is designed to measure the safety and how well it works 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.

Official registry: https://clinicaltrials.gov/study/NCT04929223 · Hoffmann-La Roche · enrollment listed as 542

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Inavolisib, Bevacizumab, or Cetuximab. The registry lists allocation as randomized. This open-label, exploratory study is designed to measure the safety and how well it works 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.

They plan to enroll about 542 people at 84 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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)

Interventions: Inavolisib, Bevacizumab, Cetuximab, Atezolizumab, Tiragolumab, SY-5609, Divarasib, FOLFOX, FOLFIRI, FoundationOne®Liquid CDx

Primary outcome (registry wording): Objective Response Rate

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Biomarker eligibility as determined by:
  • 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
  • Blood-based FoundationOne Liquid CDx biomarker eligibility test result generated prior to or during screening or, in case of re-enrollment after treatment discontinuation, prior to starting a new anti-cancer therapy
  • 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

Public study contact (from the registry)

Reference Study ID Number: WO42758 https://forpatients.roche.com/ No attachments to email below.

888-662-6728 (U.S. and Canada)

global-roche-genentech-trials@gene.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

84 listed

+ 49 sites outside the US on the same record

Related recruiting trials in this snapshot

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NCT00001823 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

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Phase 2: testing Pembrolizumab (Keytruda) for Metastatic Colorectal Cancer

Background: The NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 200 patients with melanoma.

NCT01174121 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

FAQ about this NCT record

Is NCT04929223 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT04929223?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT04929223?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary