drugset / Trial / NCT03604783

Phase 1, First-in-human Study of Oral TP-1287 in Patients with Advanced Solid Tumors

NCT03604783 ↗

Phase 1 Terminated 74 enrolled Sumitomo Pharma America, Inc.
NaSingle-groupOpen-labelTreatment

Summary

TP-1287 is an oral phosphate prodrug of the CDK9 inhibitor, alvocidib. This is a Phase 1, open-label, dose-escalation, dose-expansion, safety, pharmacokinetics, and pharmacodynamic study, with a purpose of determining the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-1287 in patients with advanced metastatic or progressive solid tumors who are refractory to, or intolerant of, established therapy known to provide clinical benefit for their condition.

Timeline

Start
2018-12-26
Primary completion
2024-01-10
Completion
2024-01-10

Outcome

Outcome not reported

Stopped: “Sponsor's decision to terminate further development of the program.”

Drugs

EvaluationDrugModalityDoseRoute
Subject TP-1287 Small molecule — Oral