NCT03454243

Oral Immunomodulatory Tyrosine Kinase Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors

A Study of RXDX-106, an Oral Immunomodulatory TYRO3, AXL, and MER (TAM) Tyrosine Kinase Inhibitor, in Patients With Locally Advanced or Metastatic Solid Tumors

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a first-in-human, open label, multicenter, dose escalation study of RXDX-106 in patients with locally advanced or metastatic solid tumors, who have no available therapy likely to convey clinical benefit. This study will examine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics and preliminary efficacy of RXDX 106.

Detailed description

The primary objective of Phase 1 is to assess safety and tolerability, determine the recommended phase 2 dose (RP2D) and assess the pharmacokinetics of RXDX-106. The secondary objective is to evaluate the preliminary antitumor activity of RXDX-106, as assessed by objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and Immune Response Related Criteria in Solid Tumors (iRECIST) in patients with advanced or metastatic solid tumors. The proposed starting dose of RXDX-106 was calculated based upon nonclinical toxicology studies to determine a recommended first-in-human starting dose, which may be below the biologically active level. Therefore, in order to minimize the number of patients treated at this dose, an accelerated titration design will be used for the first cohort, after which, a conventional 3+3 scheme will be followed for enrollment in subsequent dose levels. Final determination of the single agent RP2D will be based on available safety, tolerability, PK, pharmacodynamics, and efficacy data from different dose levels and schedules tested, but will be no higher than the maximum tolerated dose. After RP2D has been determined, additional expansion cohorts of patients (up to 15) with specific tumor types, treatment history, and/or expression of a specific biomarker may be enrolled.

Conditions

• Advanced or Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	RXDX-106	Patients will receive continuous daily oral doses of RXDX-106 in 21 day cycles. To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), study drug will be administered in an escalated fashion starting at dose of 10 mg/day and will proceed at the dose levels prespecified by the dose escalation schema. Once daily dosing for RXDX-106 will initially be tested. However, other dosing schedules (eg, every other day, weight based, etc) may be tested based on safety and PK data to optimize drug exposure.

Timeline

• Start date: 2018-02-15
• Primary completion: 2018-06-05
• Completion: 2018-06-05
• First posted: 2018-03-05
• Last updated: 2019-04-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study