ctDNA-guided Adaptive Therapy Escalation in ER+,PR+ MBC:
A Pilot Study with Letrozole + Palbociclib + Onapristone XR

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

Trial Titles:
Onward 202

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

ClinicalTrials.gov Identifier:
NCT04872608 (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 has not been approved for marketing by any regulatory authority.

Disease Indication:
Biochemically-recurrent ER+,PR+,HER2- metastatic breast cancer.

Clinical Trial Description:
This is an investigator initiated, open-label, single institution pilot study of the oral progesterone receptor antagonist, ONA-XR, added as escalation therapy with estrogen receptor positive (ER+) progesterone receptor positive (PR+) HER2 negative (HER2-) metastatic breast cancer who do not achieve molecular complete response (mCR) after six months of treatment with letrozole and palbociclib in the first line.

Principal Investigators:

• Komal Jhaveri, MD

• Pedram Razavi, MD, PhD

• Joshua Drago, MD

Trial Sites: