SDP Oncology Announces First Patient Dosed in Phase 1 Dose Expansion Study of TP-1287 in Patients with Sarcoma

November 11, 2021

Sumitomo Dainippon Pharma Oncology (SDP Oncology), which has research facilities in Lehi, Utah, recently announced that the first patient has been dosed in the Phase 1 dose expansion portion of the study evaluating the investigational agent TP-1287, an oral cyclin-dependent kinase 9 (CDK9) inhibitor, in patients with sarcoma.

“Patients with sarcoma currently face a significant unmet need and have limited treatment options. The dose expansion of TP-1287 provides an opportunity for us to evaluate this treatment and its potential benefits for this patient population,” said Patricia S. Andrews, Chief Executive Officer, Global Head of Oncology, Sumitomo Dainippon Pharma Oncology, Inc (SDP Oncology). “Furthermore, this is an important step forward for our Phase 1 trial as we continue to evaluate TP-1287’s safety and efficacy.”

The primary objective of the Phase 1 dose expansion portion of the study is to evaluate the preliminary antitumor activity of TP-1287 in terms of objective response rate (ORR) when administered at the RP2D in patients with sarcoma subtypes. The secondary objectives are to determine the progression-free survival (PFS), PFS rate at 16 weeks and PFS rate at 24 weeks following first administration of TP-1287 in patients with the defined sarcoma subtypes and evaluate the safety of TP-1287 when administered at the RP2D in patients with the defined sarcoma subtypes.

Additional information on this trial, including comprehensive inclusion and exclusion criteria, can be accessed at www.ClinicalTrials.gov (NCT03604783).