Benzinga | Oct 27, 2021 07:35AM EDT

Context Therapeutics, Wisconsin Oncology Network Report First Patient Dosed In Phase 2 Trial Of ONA-XR In Metastatic Breast Cancer

Trial Will Evaluate Progesterone Receptor ONA-XR in Combination with Estrogen Receptor Antagonist to Determine Potential of Complete Hormone Blockade on Metastatic Breast Cancer Outcomes

PHILADELPHIA, Oct. 27, 2021 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (NASDAQ:CNTX), a women's oncology company developing advanced small molecule and immunotherapy treatments to transform care for hormone-driven breast and gynecological cancers, and Wisconsin Oncology Network (WON), today announced the first patient has been dosed in the Phase 2 Trial of OnapriStone in CoMbInation with FuLvestrant for Patients with ER-positive, and HER2-negative Metastatic Breast Cancer after Progression on Endocrine therapy and CDK 4/6 Inhibitors (The SMILE Study).

The single-arm trial conducted by the WON will evaluate the effect of progesterone receptor (PR) antagonist onapristone extended release (ONA-XR) in combination with Faslodex (fulvestrant) for women and men with ER+, PR+, HER2-negative metastatic breast cancer after treatment failure of CDK4/6 inhibitor and/or PIK3? inhibitors. Estrogen and progesterone drive progression in many breast cancer patients, but resistance after endocrine therapy is a clinical challenge given the broad use of antiestrogens. ONA-XR is an investigational, orally-administered full antagonist of PR, a key unchecked mechanism in women's cancers, and this clinical trial will evaluate the potential of ONA-XR and fulvestrant to address this resistance and improve patient outcomes. ONA-XR is currently being evaluated in ongoing Phase 2 clinical trials in hormone-driven breast, ovarian and endometrial cancers.

The trial will enroll up to 39 patients with ER+, PR+, HER2- metastatic breast cancer who have progressed on aromatase inhibitor and CDK4/6 inhibitor combination therapy. The primary endpoint will be the overall response rate (ORR), which is the proportion of patients with a complete or partial tumor response. Secondary endpoints will include duration of tumor response, progression-free survival (PFS), disease control rate, time to response and incidence of adverse events.

"Context is honored to have WON Co-Principal Investigators Sailaja Kamaraju, MD, MS, Associate Professor at the Medical College of Wisconsin, Milwaukee and Kari Wisinski, MD, Professor, Interim Chief of the Division of Hematology, Medical Oncology and Palliative Care for the Department of Medicine at UW-Madison to spearhead this important research collaboration and explore this combination as a potential additional treatment option for patients living with this devastating disease," said Martin Lehr, CEO of Context Therapeutics. "We hope this study will provide a robust picture of how ONA-XR works in advanced ER+, PR+, HER2- breast cancer and inform the design of a future Phase 3 trial."

Additional information about the trial, which is recruiting patients, can be found on clinicaltrials.gov using the identifier NCT04738292.