Protocol #: 18-289
Status
Recruiting
Description
TP-0184 is a potent inhibitor of ALK2 or ACRV1 kinase, a constitutively active serine/threonine receptor kinase due to activating mutations or upregulated upstream signaling pathways. This is a Phase 1, open-label, dose-escalation, safety, pharmacokinetics, and pharmacodynamic study, with a purpose of determining the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-0184 administered daily for 21 days in patients with advanced solid tumors.
Condition
Advanced Solid Tumors
Interventions
TP-0184
Phase
Phase 1
Study Type
Interventional
Further Study Details
Primary Outcome:
Incidence of dose-limiting toxicities (DLTs) and treatment emergent adverse events
Determine maximum tolerated dose (MTD)
Secondary Outcome:
Recommended Phase 2 Dose of TP-0184
Determine antitumor activity of TP-0184
Estimated Enrollment
40
Study Start Date
July 10, 2018
Eligibility
Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Health Volunteers: No
Criteria
Tolero Pharmaceuticals, Inc.
Information Provided By
Tolero Pharmaceuticals, Inc.
Official Title
A Phase I, First-in-human, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-0184 Administered Daily for 21 Days to Patients With Advanced Solid Tumors
Clinicaltrials.gov Identifier
NCT03429218

 

 

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.

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