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Context Therapeutics® and Jefferson Health Announce First Patient Dosed in Phase 2 Trial of ONA-XR in Advanced Endometrial Cancer | ||
By: GlobeNewswire - 12 May 2021 | Back to overview list |
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Trial Will Evaluate Progesterone Receptor ONA-XR in Combination with Antiestrogen to Determine Potential of Complete Hormone Blockade on Endometrial Cancer Outcomes PHILADELPHIA, May 12, 2021 (GLOBE NEWSWIRE) -- Context Therapeutics, a women’s oncology company developing advanced small molecule and immunotherapy treatments to transform care for hormone-driven breast and gynecological cancers, and the Sidney Kimmel Cancer Center – Jefferson Health, today announced the first patient has been dosed in the Phase 2 ONWARD 221 trial in patients with metastatic endometrial cancer. The trial, sponsored by Jefferson Health, is a clinical collaboration between Context and Jefferson Health’s Sidney Kimmel Cancer Center (SKCC) to evaluate the effect of the addition of progesterone receptor (PR) antagonist onapristone extended release (ONA-XR) to the antiestrogen, anastrozole, on outcomes for patients with metastatic endometrial cancer who have failed prior therapy. ONA-XR is an orally-administered full antagonist of the PR, a key unchecked mechanism in women’s cancers. ONA-XR is currently being evaluated in ongoing Phase 2 clinical trials in hormone-driven breast, ovarian and endometrial cancers. “The majority of endometrial cancer patients have hormone-driven cancer. Both estrogen and progesterone drive progression in those patients, and antiestrogens, most often anastrozole, have proven, albeit limited, activity,” said Russell Schilder, MD, Co-Principal Investigator and Director of the Gynecologic Medical Oncology Program at SKCC. “We will evaluate whether combining anastrozole with ONA-XR will achieve more complete hormone blockade compared with anastrozole alone, which may lead to better outcomes for patients.” The trial will enroll up to 25 patients who express the ER and/or PR biomarker (ER+ &/or PR+) and who have received prior chemotherapy treatment. The primary endpoint will be overall response rate (ORR), which is the proportion of patients who have either a complete or partial response. Secondary endpoints will include duration of response, clinical benefit rate and progression-free survival (PFS). In addition, the trial will evaluate the safety and pharmacological profile, as well as biomarker analyses to explore predictive factors of response to complete hormone blockade to inform additional ongoing Phase 2 trials of ONA-XR and a planned future Phase 3 trial. “Context is humbled by the support and enthusiasm of Dr. Schilder and his colleagues at SKCC, one of the premier gynecologic oncology programs in the country based right here in Philadelphia,” said Martin Lehr, CEO of Context Therapeutics. “Patients with advanced endometrial cancer currently have limited therapeutic options. Recent preclinical and Phase 1 data give us reason to believe ONA-XR can make a powerful addition to the current standard of care in hormone-driven endometrial cancer. Together, we look forward to exploring the potential of this combination to improve the lives of patients with this devastating disease.” For more information on the trial, visit About Endometrial Cancer About Onapristone Extended Release About Context Therapeutics® About the Sidney Kimmel Cancer Center – Jefferson Health Media Contacts: For Context For SKCC |
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