Advanced or Metastatic Solid Tumors Clinical Trial
Official title:
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
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.
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.
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