A Study of TPX-0005 in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements



Status:Recruiting
Conditions:Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/8/2019
Start Date:February 27, 2017
End Date:December 2021
Contact:Shanna Stopatschinskaja, M.D.
Email:clinical@tptherapeutics.com
Phone:(858) 276-0005

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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)

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.


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.
We found this trial at
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-724-4000
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Phone: 720-848-0676
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 646-888-4425
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Orange, California 92868
Phone: 877-827-8839
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Seoul,
Phone: +82-2-2072-2995
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