Phase 2 Trial Evaluating the Combination of Onapristone Extended Release with Anastrozole for Women with Advanced Hormone Receptor Positive Endometrial Cancer

Trial Status:
Enrollment in this Phase 2 study is open.

For More Trial Information:
Please contact info@contextherapeutics.com or visit clinicaltrials.gov.

ClinicalTrials.gov Identifier:
NCT04719273 (Link)

Program (Target):
Onapristone extended release (ONA-XR) is a potent and specific antagonist of the progesterone receptor that is orally administered. Currently, there are no approved therapies that selectively target PR+ cancers. Preliminary preclinical and clinical data suggest that ONA-XR has anticancer activity by inhibiting the binding of progesterone receptor to chromatin, downregulating cancer stem cell mobilization, and blocking immune evasion. ONA-XR is an investigational drug that has not been approved for marketing by any regulatory authority.

Disease Indication:
Advanced endometrial cancer.

Clinical Trial Description:
A prospective, Phase 2 single arm, multicenter study assessing the effect of Aromasin (anastrozole) in combination with ONA-XR in women with ER+, PR+ metastatic endometrial cancer after progression on at least one prior line of chemotherapy.

Mechanism of Action:

Progesterone receptor (PR) is enriched, referred to as “PR+”, in approximately 60% of endometrial cancer patients. PR enrichment and activation is driven by hormones (estrogen and progesterone) and MAPK-mediated post-translational modifications [1]. PR antagonists, including onapristone and mifepristone, have exhibited tumor modulation in preclinical models as well as human clinical trials [2,3].

Trial Sites:

[1] Yang-Hartwich, Science Reports, 2014
[2] Rocereto, Gyn Oncology, 2000
[3] Cottu, Plos One, 2018