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

Summary

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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...

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 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

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