TP-1287

P1, N=74, Terminated, Sumitomo Pharma America, Inc. | Trial completion date: Oct 2024 --> Jan 2024 | Recruiting --> Terminated | Trial primary completion date: Jun 2024 --> Jan 2024; Sponsor's decision to terminate further development of the program.

TP-1287 is an investigational orally delivered phosphate prodrug of the CDK9 inhibitor alvocidib. EWS dose expansion cohort is currently recruiting in the United States. Clinical trial information: NCT03604783.

Taken together, alvocidib has shown activity in inhibiting the growth of sarcoma cells and TP-1287 could be a viable therapeutic option targeting the CDK9 pathway in sarcomas. TP-1287 is being investigated for solid tumors including sarcomas (clinicaltrials.gov, NCT03604783).

TP-1287 is an orally delivered phosphate prodrug of the CDK9 inhibitor alvocidib. The RP2D was established as 11 mg BID continuous dosing. The dose expansion cohort is open for enrollment.Table. Safety >

TP-1287 is a novel oral prodrug of alvocidib, a potent CDK9 inhibitor, and is currently under clinical investigation in patients with advanced solid tumors (clinicaltrials.gov, NCT03604783). Taken together, TP-1287 demonstrated potent cell and tumor growth inhibition in multiple hematological cell lines, including AML and MM. Furthermore, a newly established flow cytometry system for p-RPB1 and MCL-1 to evaluate CDK9 inhibition in human PBMCs was developed, which could be useful as a surrogate biomarker for TP-1287 in clinical trials and warrants further investigation.

Background: TP-1287 is a an orally bioavailable phosphate prodrug of alvocidib, a cyclin dependent kinase 9 (CDK9) inhibitor. These findings suggest that TP-1287 is tolerated as a monotherapy in patients with heavily pretreated, relapsed, refractory solid tumors and further clinical development in selected indications is warranted. Research Funding: Tolero Pharmaceuticals, Inc