NCT05542407 is a Phase 1 clinical trial of Atezolizumab in Endometrial Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center.

Who is sponsoring NCT05542407?

NCT05542407 is sponsored by UNC Lineberger Comprehensive Cancer Center.

What drugs are being tested in NCT05542407?

Interventions in NCT05542407: Atezolizumab, ONC201.

What condition does NCT05542407 study?

NCT05542407 studies Endometrial Cancer, Metastasis, Endometrioid Endometrial Cancer, Carcinosarcoma, Serous Adenocarcinoma of Endometrium (Diagnosis), Clear Cell Endometrial Carcinoma, Endometrial Endometrioid Adenocarcinoma, Endometrial Mixed Cell Adenocarcinoma.

Is NCT05542407 still recruiting?

NCT05542407 is currently recruiting now. Last updated 29 January 2026.

Last reviewed 2026-01-29 · How we verify

NCT05542407

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer

Recruiting now Phase 1 Last updated 29 January 2026

What this trial tests

Phase 1 trial testing Atezolizumab in Endometrial Cancer in 58 participants. Currently enrolling.

Timeline

23 October 2023

Primary endpoint
21 February 2028

31 July 2028

Quick facts

Lead sponsor	UNC Lineberger Comprehensive Cancer Center
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	58
Start date	23 October 2023
Primary completion	21 February 2028
Estimated completion	31 July 2028
Sites	1 location across United States

Drugs / interventions tested

Atezolizumab (atezolizumab) — full drug profile →
ONC201 — full drug profile →

Conditions studied

Endometrial Cancer — all drugs for Endometrial Cancer →
Metastasis — all drugs for Metastasis →
Endometrioid Endometrial Cancer — all drugs for Endometrioid Endometrial Cancer →
Carcinosarcoma — all drugs for Carcinosarcoma →

Sponsor

UNC Lineberger Comprehensive Cancer Center — full company profile →

Who can join

18 and older, female only, with Endometrial Cancer or Metastasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Endometrial cancer (EC) is the fourth most common cancer in United States women, and alarmingly, the frequency and mortality from EC continues to rise, in part due to the obesity epidemic. Obese women with EC have a 6.3-fold increased risk of death from this disease, as compared to their non-obese counterparts. Patients with advanced/recurrent EC are unlikely to be cured by surgery, conventional chemotherapy (paclitaxel + carboplatin is the standard first-line treatment), radiation, or a combination of these. Thus, new treatments for EC are desperately needed as well as a better understanding of the impact of obesity on EC biology and treatment. The purpose of this study is to test the safety of a combination of treatments, atezolizumab and ONC201, given based on body weight, to treat endometrial cancer. Using the combination of atezolizumab and ONC201, has not been approved by the Food and Drug Administration (FDA) for the treatment of endometrial cancer. This clinical trial will examine the treatment of atezolizumab + ONC201 in obese and non-obese subjects with metastatic/recurrent EC.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

A review of current therapeutics targeting the mitochondrial protease ClpP in diffuse midline glioma, H3 K27-altered.
Jackson ER, Persson ML, Fish CJ, Findlay IJ, et al · · 2024 · cited 30× · PMID 37589388 · DOI 10.1093/neuonc/noad144
Mammalian integrated stress responses in stressed organelles and their functions.
Lu HJ, Koju N, Sheng R. · · 2024 · cited 29× · PMID 38267546 · DOI 10.1038/s41401-023-01225-0
Targeting Mitochondria with ClpP Agonists as a Novel Therapeutic Opportunity in Breast Cancer.
Wedam R, Greer YE, Wisniewski DJ, Weltz S, et al · · 2023 · cited 22× · PMID 37046596 · DOI 10.3390/cancers15071936
Metabolic vulnerability of cancer stem cells and their niche.
Marrone L, Romano S, Malasomma C, Di Giacomo V, et al · · 2024 · cited 3× · PMID 38659591 · DOI 10.3389/fphar.2024.1375993

Verify or expand the search:

Other trials of Atezolizumab

Trials testing the same drug.

NCT07388524 — Testing the Impact of an Anti-Cancer Drug, Atezolizumab, After Surgery to Prevent Early Stage Non-small Cell Lung Cancer · Phase 3 · not yet recruiting
NCT07322341 — SX-682 and Atezolizumab for the Treatment of Advanced or Metastatic, Recurrent Non-small Cell Lung Cancer · Phase 2 · not yet recruiting
NCT07339059 — Phase II Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Ce · Phase 2 · recruiting
NCT07461675 — Effects of Neoadjuvant Immunotherapy on Anti-tumour Immunity in Hepatocellular Carcinoma Patients Undergoing Liver Resec · Phase 3 · not yet recruiting
NCT07291076 — A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants Wit · Phase 1, PHASE2 · recruiting

Other recruiting trials for Endometrial Cancer

Currently open trials in the same condition.

NCT07419841 — A Phase 1 Study of the Safety and Tolerability of CTX-10726 · Phase 1 · recruiting
NCT07382583 — Development of a Shared Decision Tool to Facilitate Uptake of the Levonorgestrel-releasing Intrauterine System for the P · recruiting
NCT07377734 — Intrauterine Injection of Type III Collage in FST of EC/AEH · Phase 2 · recruiting
NCT07319429 — Refining Fertility-sparing Treatment in Endometrial Carcinoma Based on Molecular Classification · Phase 2, PHASE3 · recruiting
NCT07397624 — Endoscopic Suture Gastroplasty (ESG) for Treatment of Obese Patients With Endometrial Cancer · recruiting

Other UNC Lineberger Comprehensive Cancer Center trials

Trials by the same sponsor.

NCT06656936 — The PharmFIT Study · NA · not yet recruiting
NCT05937659 — Incorporating Biometric Data for Patients Receiving Concurrent Chemotherapy & RT · not yet recruiting
NCT07479199 — Local Radiofrequency Ablation Plus External Beam Radiation for the Treatment of Painful Thoracic and Lumbar Spine Tumors · not yet recruiting
NCT07069595 — PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease · Phase 2 · recruiting
NCT04266730 — Trial of a Personalized and Adaptive Neoantigen Dose-Adjusted Vaccine Concurrently With Pembrolizumab · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05542407 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center
Last refreshed: 29 January 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05542407.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing