Summary

for people ages 18 years and up (full criteria)
at Orange, California and other locations
study started
estimated completion

Description

Summary

Phase 1 will assess safety and tolerability of TPX-0005 via a standard dose escalation scheme, and determine the recommended phase 2 dose. Phase 2 will assess safety and efficacy of TPX-0005.

Official Title

A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)

Keywords

Locally Advanced Solid TumorsMetastatic Solid TumorsNon Hodgkin LymphomaALK Gene RearrangementROS1 Gene RearrangementNTRK 1/2/3 Gene RearrangementNeoplasmsLymphoma, Non-HodgkinOral TPX-0005TPX-0005

Eligibility

For people ages 18 years and up

Key Inclusion Criteria:

  1. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumor (including non-Hodgkin Lymphoma) (Stage IV, AJCC v.7) that harbors an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement by protocol specified tests.
  2. ECOG PS 0-1.
  3. Age ≥18 (or age ≥ 20 of age as required by local regulation).
  4. At least 1 measurable target lesion according to RECIST version 1.1. CNS-only measurable disease as defined by RECIST version 1.1 is allowed.
  5. Prior cytotoxic chemotherapy is allowed.
  6. Prior immunotherapy is allowed.
  7. Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1.
  8. Patients with asymptomatic CNS involvement are allowed.
  9. Life expectancy ≥ 3 months.

Key Exclusion Criteria:

  1. Concurrent participation in another therapeutic clinical trial.
  2. Symptomatic CNS involvement.
  3. Any of the following cardiovascular history in the past 6 months: myocardial infarction, unstable angina, coronary/ peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, symptomatic bradycardia, requirement for anti-arrhythmic medication.
  4. History of prolonged QTc interval.
  5. Known active infections (bacterial, fungal, viral including HIV positivity).
  6. Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact drug absorption.
  7. Peripheral neuropathy ≥ Grade 2.
  8. Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis. Patients with a history of prior radiation pneumonitis are not excluded.

Locations

  • UC Irvine Health, Chao Family Comprehensive Cancer Centeraccepting new patients
    OrangeCalifornia92868United States
  • University of Colorado Denveraccepting new patients
    AuroraColorado80045United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
TP Therapeutics, Inc.
ID
NCT03093116
Phase
Phase 1/2
Study Type
Interventional
Last Updated