Actively Recruiting
Phase 1 Clinical Trial of ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2026-01-29
58
Participants Needed
1
Research Sites
23 weeks
Total Duration
On this page
Sponsors
U
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Endometrial cancer is a common cancer among women in the United States, with rising cases and mortality linked to obesity. This trial studies a combination of two treatments, atezolizumab and ONC201, to explore their safety in treating advanced or recurrent endometrial cancer. The study focuses on both obese and non-obese patients to better understand how obesity affects the disease and treatment response. Participants receive atezolizumab intravenously on the first day of each 21-day cycle, with doses based on body weight. ONC201 is given orally once or twice a week in doses ranging from 375 mg to 625 mg. The study includes two groups: those with a body mass index (BMI) over 30 and those with a BMI 29.9 or lower. This Phase 1 trial aims to find the recommended dose for future studies. During the study, participants undergo regular assessments to track tumor response, survival rates, and treatment safety for up to two years. Researchers measure the recommended Phase 2 dose within three weeks of starting treatment. Patients are monitored through imaging, laboratory tests, and physical exams to evaluate disease progression and overall health. The study is non-randomized and does not use masking, allowing close observation of treatment effects in each group.
CONDITIONS
Brief Title
ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign informed consent and HIPAA authorization
- Age 18 years or older at consent
- ECOG Performance Status of 0, 1, or 2
- Histologically confirmed metastatic or recurrent endometrial cancer of specified types
- Measurable disease per RECIST criteria
- Radiographic disease progression after at least 1 line of systemic cytotoxic therapy or progression within 12 months of adjuvant chemotherapy
- Life expectancy of at least 3 months
- Adequate organ function based on screening labs within 72 hours prior to treatment
You will not qualify if you...
- Prior treatment with ONC201
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies including anti-CTLA-4 and anti PD-L1 antibodies
- Use of another investigational agent or participation in another clinical trial within 28 days before starting this study
- Chemotherapy or radiotherapy within 4 weeks prior to study treatment or unresolved adverse events from earlier treatments
- Therapeutic oral or IV antibiotics within 2 weeks prior to therapy start (prophylactic antibiotics allowed)
- Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives prior to therapy
- Treatment with systemic immunosuppressive medication within 2 weeks prior to therapy start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 3 weeks
Participants receive ONC201 orally once or twice weekly and Atezolizumab intravenously on day 1 of each 21-day cycle.
Weekly visits for up to 3 weeks
Trial Site Locations
Total: 1 location
1
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
D
De'Andrea Taylor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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