Internal Development Programs
|Program||Indication||Preclinical||Phase 1||Phase 2||Phase 3||Next Catalyst||NCT#|
|XBIO-101||Progesterone Resistant Endometrial cancer||
Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase in progress
Phase 3 Phase not started
|Interim Phase 2 data expected in 2018||NCT03077698|
Progesterone Resistant Endometrial Cancer Clinical Trials
The primary objective of the open-label, multi-center, single-arm, two-period Phase 2 study is to assess the antitumor activity of XBIO-101 in conjunction with progestin therapy as measured by Overall Disease Control Rate in women with recurrent or persistent endometrial carcinoma not amenable to surgical treatment or radiotherapy who have either failed progestin monotherapy or who have been identified as PrR-.
Secondary objectives of the study are:
- to assess progression-free survival, time to response, time to progression, duration of overall survival and Overall Disease Control Rate for subjects receiving XBIO-101 and progestin therapy; and
- to evaluate the safety and tolerability of XBIO-101 in conjunction with progestin therapy, as measured by adverse events, laboratory safety parameters, and cardiac safety assessments.
The study is expected to enroll a total of 72 women with recurrent or persistent endometrial cancer not amenable to surgical treatment or radiotherapy but suitable to be treated with progestins. All subjects determined to be PrR- at screening, as well as those subjects who experience disease progression after at least 4 weeks of progestin monotherapy, will receive XBIO-101 in combination with continued progestin treatment. Subjects will receive treatment until disease progression as defined according to RECIST 1.1 criteria.
For more information on this Phase 2 study of XBIO-101 for the treatment of PrR-negative endometrial cancer, please visit www.clinicaltrials.gov and reference Identifier NCT03077698.