On November 3, 2021 Sumitomo Dainippon Pharma Oncology, Inc., a clinical-stage company focused on research and development for novel cancer therapeutics, reported 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 (Press release, Sumitomo Dainippon Pharma, NOV 3, 2021, View Source [SID1234594286]).
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The Phase 1 open-label study consists of two parts, dose escalation and dose expansion. The dose escalation portion of the study established the maximum tolerated dose (MTD) and recommended Phase 2 Dose (RP2D) of TP-1287 in patients with advanced metastatic or progressive solid tumors. The dose expansion portion of the study will evaluate the potential antitumor activity and safety of TP-1287 in patients with Ewing sarcoma (EWS), dedifferentiated liposarcoma (DDLPS) and synovial sarcoma (SS).
"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.
The study is being conducted at sites in the United States. Additional information on this trial, including comprehensive inclusion and exclusion criteria, can be accessed at www.ClinicalTrials.gov (NCT03604783).
About TP-1287
TP-1287 is an investigational oral CDK9 inhibitor that has shown favorable oral bioavailability in preclinical models. TP-1287 is enzymatically cleaved, yielding the active moiety, a potent inhibitor of CDK9.1 Inhibiting CDK9 is thought to downregulate the transcription of target genes, including MCL-1, reducing leukemic blast viability in MCL-1–dependent hematologic malignancies, and c-MYC, an important oncogene across multiple tumor types.2,3,4 TP-1287 is currently being evaluated in a Phase 1 study in patients with advanced solid tumors (NCT03604783).