TRIDENT-1 : 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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

One/TwoPhase One/Two

12+Age Over 12

Advanced CancersCancer LocationMulti-Cancer
Trial

Systemic therapy | Blood / Myeloma / Lymphoma,Bowel (colorectum),Brain and spinal cord,Breast,Lung,Sarcoma,Stomach and upper gastrointestinal tract,Urinary systemB-Cell Non Hodgkin Lymphoma,Breast,Colorectum,Glioblastoma (GBM) ,Non-Small Cell Lung Cancer,Oesophagus,Renal cell carcinoma,Sarcoma,Soft Tissue Sarcoma,Stomach

Trial Overview Read MoreRead more

This phase I/II trial is trying to determine the safety and tolerability of an oral drug, repotrectinib.
 

This trial is treating patients with advanced or metastatic cancers that have an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific 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

Commercial Sponsor

Turning Point Therapeutics, Inc.

Summary

This is a dose escalation (Phase I) and expansion (Phase II) trial. In Phase I, eligible participants will receive escalating doses of Oral repotrectinib, to determine the first cycle dose-limiting toxicities, maximum tolerated dose, biologically effective dose and recommended phase 2 dose. In Phase II, participants will receive Oral repotrectinib across six distinct expansion cohorts, depending on their prior treatment and disease progression.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Ms Marian Lieschke
marian.lieschke@petermac.org
03 8559 7140

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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