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Endometrial CancerGeneticsDrugPhase 1, Phase 2

What this study is

This is a Phase IB/II multi-cohort study designed to evaluate the efficacy and safety of targeted agents with or without cancer immune checkpoint therapy with atezolizumab in participant with recurrent and/or persistent endometrial cancer. The main protocol provides a platform for genomic screening with homogeneous basic eligibility criteria in order to direct study participants into biomarker-matched study cohorts consisting of testing targeted agents.

What's being tested

  • Atezolizumab - 28 Day Cycle

    Intervention · DRUG

    Atezolizumab will be given to participants intravenously at a dosage of 1680 mg on day 1 of each 28-day cycle.

  • Bevacizumab

    Intervention · DRUG

    Bevacizumab will be given to participants intravenously at a dosage of 10mg per participant kilogram every 2 weeks of the 28-day cycle.

  • Ipatasertib

    Intervention · DRUG

    Ipatasertib will be given as an orally at a dosage of 400 mg once daily for 21 days of each 28-day cycle.

  • Talazoparib

    Intervention · DRUG

    Talazoparib will be given in an orally at a dosage of 1 mg once daily for each day of the 28-day cycle.

  • Trastuzumab emtansine

    Intervention · DRUG

    Trastuzumab emtansine be given to participants intravenously at a dosage of 3.6 mg per participant kilogram, on day 1 of each 21-day cycle.

  • Tiragolumab

    Intervention · DRUG

    Tiragolumab will be given to participants intravenously at a dosage of 840 mg on day 1 of each 28-day cycle.

  • Atezolizumab - 21 Day Cycle

    Intervention · DRUG

    Atezolizumab will be given to participants intravenously at a dosage of 1200 mg on day 1 of each 21-day cycle.

  • Inavolisib

    Intervention · DRUG

    Inavolisib will be given in an orally at a dosage of 9 mg once daily for each day of the 28-day cycle.

  • Letrozole

    Intervention · DRUG

    Letrozole will be given orally at a dosage of 2.5 mg once daily for each day of the 28-day cycle.

  • Giredestrant

    Intervention · DRUG

    Giredestrant will be given orally at a dosage of 30 mg once daily for each day of the 28-day cycle.

  • Abemaciclib

    Intervention · DRUG

    Giredestrant will be given orally at a dosage of 150 mg twice daily for each day of the 28-day cycle.

Study details

Official title
A Phase IB/II Multi-Cohort Study of Targeted Agents and/or Immunotherapy With Atezolizumab for Patients With Recurrent or Persistent Endometrial Cancer
Sponsor
Alliance Foundation Trials, LLC.
Conditions
Endometrial Cancer
Enrolling
148 people
Starts
2021-10-20
Est. completion
2027-10
Design
Open-label, non-randomized, parallel groups, Phase 1, Phase 2
Record
View on ClinicalTrials.gov ↗