NCT03604783

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

A Phase 1, First-in-human, Open-label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-1287 to Patients with Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objective: * During Dose Escalation: To determine 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. * During Dose Escalation: To establish the Recommended Phase 2 Dose (RP2D) for future studies with TP-1287 * During Dose Expansion: 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 (ie, EWS, DDLPS and SS) * During Dose Expansion: To evaluate the preliminary antitumor activity of TP-1287 in terms of clinical benefit rate (CBR) at week 16 when administered at the RP2D in patients with the defined sarcoma subtypes Secondary Objectives: * During Dose Escalation: To establish the pharmacokinetics of orally administered TP-1287 * During Dose Escalation: To observe patients for any evidence of antitumor activity of TP-1287 by objective radiographic assessment * During Dose Escalation: To study the pharmacodynamics of TP-1287 therapy * During Dose Expansion: To determine the median progression-free survival (PFS) rate in patients with sarcoma * During Dose Expansion: To evaluate the safety of TP-1287 when administered at the RP2D in patients with sarcoma

Conditions

• Advanced Solid Tumors
• Sarcoma
• Ewing Sarcoma
• Dedifferentiated Liposarcoma
• Synovial Sarcoma

Interventions

Type	Name	Description
DRUG	TP-1287	TP-1287 by oral administration

Timeline

• Start date: 2018-12-26
• Primary completion: 2024-01-10
• Completion: 2024-01-10
• First posted: 2018-07-27
• Last updated: 2024-09-19

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study