On May 2, 2019 Context Therapeutics, a clinical-stage biopharmaceutical company dedicated to advancing medicines for hormone driven cancers, reported the start of an open-label (NCT03909152) basket study to evaluate the efficacy and safety of Apristor (onapristone extended release) in advanced gynecological tumors that are progesterone receptor positive (PgR+) (Press release, Context Therapeutics, MAY 2, 2019, View Source [SID1234535585]). Rachel N. Grisham, MD of Memorial Sloan Kettering Cancer Center is the study’s Primary Investigator.
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The Phase 2 trial will include patients who have different PgR+ solid tumors in advanced stages, including low grade serous ovarian, granulosa cell, and endometrioid endometrial cancer, who have received prior chemotherapy treatment. The progesterone receptor antagonist Apristor will be assessed in up to 84 cancer patients. The primary endpoint will be overall response rate (ORR), which is the proportion of patients who have either a complete or partial response. To further characterize the activity of Apristor, secondary endpoints will include duration of response, clinical benefit rate, and progression-free survival (PFS). In addition, this study will evaluate the safety and pharmacological profile of Apristor in these patients, as well as biomarker analyses to explore predictive factors of response to Apristor. Preliminary trial results are expected in mid-2020.
"Currently, there are limited therapeutic options to treat these cancers in the advanced setting. Recent preclinical findings, together with Phase 1 study results in patients with advanced PgR+ ovarian and endometrial cancers, give us reason to believe that Apristor can help these women with PgR+ gynecological cancers," said Tarek Sahmoud, MD, PhD, Chief Medical Officer of Context Therapeutics. 1,2 "We believe Apristor can make a meaningful difference for patients in the trial."
For more information about the trial being conducted, please visit: View Source
About Apristor
Apristor (onapristone extended release) is an investigational new drug that is an orally administered full progesterone receptor antagonist. Currently, there are no approved therapies that selectively target PgR+ cancers. In a recent Phase 1 trial, Apristor was well tolerated and exhibited clinical benefit in heavily pretreated patients with PgR+ endometrial, ovarian and breast cancer. Preclinical data suggest that Apristor has anticancer activity by blocking the activation of progesterone receptor signaling by progesterone and/or mitogenic growth factors, inhibiting mammosphere formation and downregulating gene signatures associated with cancer stem cell mobilization and metastasis3,4.