21 subjects with mCRPC were enrolled into one of six cohorts of ascending TRC253 doses.
The clinical stage biopharmaceutical firm TRACON Pharmaceuticals has reportedly announced an update on its TRC253 program for metastatic castrate resistant prostate cancer therapy. The treatment was licensed from Janssen Pharmaceutica N.V. in the year 2016.
Reportedly, phase 1 data from the ongoing phase 1/2 clinical trial has been published in the 2019 ASCO Proceedings. 21 subjects with mCRPC were enrolled into one of six cohorts of ascending TRC253 doses. The enrolled patients had earlier progressed on prior Erleada™ (apalutamide) treatment.
Target PK exposures were attained consistently with the 280 mg daily oral dose – which apparently was selected as the suggested phase 2 dose. The sole patient with a F877L androgen receptor point mutation at standard point had been continued on medication for 49 weeks (with a partial response by RECIST).
Apparently, rest of the 20 subjects were observed to lack a F877L AR point mutation at starting point. 48% (10) patients remained on trial for minimum 6 months and 1 patient had more than 50% decline in prostate specific antigen (PSA). TRC253 was well-tolerated and drug-related serious harmful events were not reported. Some of the adverse events related to drug included elevated lipase, QTcF prolongation, fatigue, diarrhea, platelet count decrease, and arthralgia.
Sources claimed that phase 2 part of the ongoing phase 1/2 trial has been updated to add an extra cohort of patients. With the added cohort, the theory of efficacy of TRC253 in mCRPC patients with a defined point transformation apart from F877L AR will be analyzed. Enrollment of patients in the additional cohort with a defined point mutation is still in process. Enrollment is also ongoing in the two current cohorts – one includes subjects with a F877L AR alteration and the second comprises subjects with another basis for resistance to Erleada or Xtandi.
Source credit: http://ir.traconpharma.com/news-releases/news-release-details/tracon-pharmaceuticals-provides-update-phase-12-trial-trc253