A Study of Giredestrant in Participants With Grade 1 Endometrial Cancer

NCT05634499 | Active Not Recruiting Phase 2 FDA Drug

• 3 other identifiers: CO441952022-002443-212023-504091-23-00
• Study Type: interventional
• Target: 30
• Locations: 4 countries
• Sites: 12

Brief Summary

This Phase II, global, single-arm study is designed to evaluate the efficacy, safety, and pharmacokinetics of giredestrant monotherapy in participants with Grade 1 endometrioid endometrial cancer.

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Who Have Regression at 6 Months

  The percentage of participants who have regression is defined as participants who have a decrease in the proportion of cancer in their endometrial biopsy or the proportion of cancer is not increased, but there is an increase in non-cancer/non-atypical hyperplasia at the 6-month assessment compared with baseline.

  Baseline, 6 Months

• Number of Participants with at Least One Adverse Event, with Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0)

  From Baseline until 30 days after the final dose of study drug (up to 1 year, 6 months)

Secondary Outcomes (5)

• Percentage of Participants Who Have Complete Regression at 6 Months

  Baseline, 6 Months

• Median Duration of Regression

  From first regression to first relapse (up to 1 year, 6 months)

• Median Time to First Regression

  From first study treatment to first regression (up to 1 year, 6 months)

• Median Time to Relapse or Loss of Clinical Benefit

  From first study treatment to relapse or loss of clinical benefit, whichever occurs first (up to 1 year, 6 months)

• Plasma Concentration of Giredestrant at Specified Timepoints

  Predose on Day 1 of Cycles 1, 2, 3, 4, and 6; 3-4 hours Postdose on Day 1 of Cycles 1 and 2 (each cycle is 28 days)

Study Arms (1)

Giredestrant

EXPERIMENTAL

Drug: Giredestrant

Interventions

Giredestrant DRUG

Participants will receive giredestrant 30 milligrams (mg) taken orally (PO) once a day (QD) on Days 1 to 28 of each 28-day cycle for 6 cycles. After completion of 6 cycles, the participant and investigator can choose to continue study treatment for an additional 18 cycles or discontinue study treatment and receive investigator-determined care.

Also known as: RO7197597, GDC-9545, RG6171

Giredestrant

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed Grade 1 endometrial cancer (EC) of endometrioid histology for which participants are willing to receive 6-cycles of study therapy. An endometrial biopsy (EMB) or dilation and curettage (D\&C) fresh collected within the screening period or archival sample collected within 3 months prior to screening must be provided to a central laboratory for histologic confirmation to determine eligibility.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Magnetic resonance imaging (MRI)-confirmation of non-deeply invasive tumor (\<50% myometrial invasion)
• MRI or computed tomography (CT)-confirmation of no extrauterine disease
• Willing to undergo a minimum of 6 continuous cycles of therapy before decision on surgery
• No prior treatment for endometrial cancer
• Able and willing to take oral medications
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
• Adequate hematologic and end-organ function, as defined in the protocol
• 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, have a CD4 count ≥200/μL, and have an undetectable viral load.
• For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrain from donating eggs, during the treatment period and for 30 days after the final dose of giredestrant, as defined in the protocol

You may not qualify if:

• Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 30 days after the final dose of giredestrant or within the time period specified per local prescribing guidelines after the final dose of the investigator's choice of endocrine therapy
• Participants with non-endometrioid histologies, such as serous, clear cell, and mixed
• Treatment with investigational therapy within 28 days prior to initiation of study enrollment
• Treatment for cancer including but not limited to, chemotherapy, immunotherapy, cyclin-dependent kinase (CDK)4/6 inhibitors, endocrine therapy, biologic therapy, or herbal therapy within 28 days prior to the initiation of study enrollment
• Any gastrointestinal condition causing malabsorption or obstruction (e.g., celiac sprue, gastric bypass surgery, strictures, adhesions, history of small bowel resection, blind loop syndrome)
• Known hypersensitivity to giredestrant or its excipients
• Known intercurrent illness or psychiatric illness/social situations that will limit compliance with study requirements
• Evidence or high suspicion of metastatic/extrauterine disease at enrollment
• Unwilling or unable to comply with study-related procedures, including all endometrial sampling/biopsies
• Planned surgery, either for the treatment of cancer or any other surgery, during the study treatment period and up to 10 days after the completion of study treatment
• Serious infections requiring IV antibiotics within 7 days prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact participant safety
• Participants who have clinically significant liver disease consistent with Child-Pugh Class B or C, including active hepatitis (e.g., hepatitis B virus \[HBV\] or hepatitis C virus \[HCV\]), current alcohol abuse, cirrhosis, or positive test for viral hepatitis, as defined in the protocol
• Treatment with strong CYP3A4 inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment
• Any serious medical condition or abnormality in clinical laboratory tests that precludes the participant's safe participation in and completion of the study
• History of other malignancy within 5 years prior to screening, except for those with an expected negligible risk for metastases or death (e.g., 5-year overall survival 90%) after curative treatment

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (12)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Minnesota Oncology Minneapolis

Minneapolis, Minnesota, 55404, United States

Location

Englewood Health/Hematology Oncology Practice of Englewood (HOPE)

Englewood, New Jersey, 07631, United States

Location

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

Texas Oncology, P.A. - Fort Worth

Fort Worth, Texas, 76104, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

McGill University Health Centre - Glen Site

Montreal, Quebec, H4A 3J1, Canada

Location

Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS

Meldola, Emilia-Romagna, 47014, Italy

Location

Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice

Gliwice, 44-101, Poland

Location

Swietokrzyskie Centrum Onkologii

Kielce, 25-734, Poland

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

giredestrant

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 2, 2022
• Study Start: June 27, 2023
• Primary Completion (Estimated): August 28, 2026
• Study Completion (Estimated): August 28, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (7); IT (1); CA (2); PL (2)