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TP-1287

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.

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

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

A DLT is defined as a drug-related toxicity that is observed to occur within the first 28 days of treatment

MTD will be determined based upon toxicity grades which are defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Objective radiographic assessment to be performed to determine antitumor activity by modified RECIST criteria

Clinical benefit rate assessment is to be performed for all patients with measureable disease at baseline by modified RECIST criteria, who achieve a CR, PR or SD and sustain the response for more than 16 weeks

To establish the Recommended Phase 2 Dose (RP2D) for future studies with TP-1287, MTD data to be reviewed

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase 1, First-in-human Study of Oral TP-1287 in Patients With Advanced Solid Tumors	NCT03604783	Advanced Solid ... Sarcoma Ewing Sarcoma Dedifferentiate... Synovial Sarcom...	TP-1287	12 Years -	Sumitomo Pharma America, Inc.
Phase 1, First-in-human Study of Oral TP-1287 in Patients With Advanced Solid Tumors	NCT03604783	Advanced Solid ... Sarcoma Ewing Sarcoma Dedifferentiate... Synovial Sarcom...	TP-1287	12 Years -	Sumitomo Pharma America, Inc.

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