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Clinical Trials

Marking a Turning Point in Patients’ Lives

At Turning Point, we are seeking to develop next-generation therapies that target genetic drivers of cancer to improve the lives of patients.

Clinical trials are studies that are critical for the investigation of new and innovative medicines. Through participation in clinical trials, patients can access investigational drug candidates, helping to play a crucial role in the process that determines a drug’s eligibility for approval by the U.S. Food and Drug Administration (FDA). At Turning Point, we are currently enrolling patients in clinical studies in patients with genetically driven solid tumor cancers.

Repotrectinib, TPX-0022, TPX-0046 and TPX-0131 are investigational drug candidates and have not been approved for marketing by the  FDA or other regulatory authorities.

Phase 1/2 TRIDENT-1: Advanced Non-Small Cell Lung Cancer (ROS1) and Solid Tumors (NTRK)

Status: Enrolling

A Study of Repotrectinib in Patients with ROS1+ Advanced Non-Small Cell Lung Cancer (NSCLC) or NTRK+ Advanced Solid Tumors

Where are the trials located?

TRIDENT-1 study locations are currently open. Visit the TRIDENT-1 study website at trident1study.com or the TRIDENT-1 page at www.ClinicalTrials.gov for a list of active sites.

Phase 1/2 CARE: Pediatric/Young Adult Advanced or Metastatic Malignancies

Status: Enrolling

A Study of Repotrectinib In Pediatric and Young Adult Subjects Harboring ALK, ROS1, or NTRK1-3 Alterations

Where are the trials located?

Pediatric/Young Adult Advanced or Metastatic Malignancies study locations are currently open. Visit the Pediatric Advanced Solid Tumor study page at www.ClinicalTrials.gov for a list of active sites.

Phase 1/2 SWORD-1: Advanced Solid Tumors (RET)

Status: Enrolling

Study of TPX-0046, A RET/SRC Inhibitor In Adult Subjects With Advanced Solid Tumors Harboring RET Fusions or Mutations

Where are the trials located?

TPX-0046 study locations are currently open. Visit the TPX-0046 study page at www.ClinicalTrials.gov for a list of active sites.

Phase 1 SHIELD-1: Advanced Solid Tumors (MET)

Status: Enrolling

Phase 1 Study of TPX-0022, a MET/CSF1R/SRC Inhibitor, In Patients with Advanced Solid Tumors Harboring Genetic Alternations In MET

Where are the trials located?

SHIELD-1 study locations are currently open. Visit the SHIELD-1 study page at www.ClinicalTrials.gov for a list of active sites.

Phase 1/2 FORGE-1: ALK+ Advanced or Metastatic Non-Small Cell Lung Cancer

Status: Enrolling

A Study of TPX-0131, a Novel Oral ALK Tyrosine Kinase Inhibitor, in Patients with ALK+ Advanced or Metastatic NSCLC

Where are the trials located?

FORGE-1 study locations are currently open. Visit the FORGE-1 study page at www.ClinicalTrials.gov for a list of active sites.

Status: Enrolling

Phase 1b/2 TRIDENT-2: KRAS Mutant Advanced Solid Tumors

Questions about our clinical trials?

Contact us via email at clinical@tptherapeutics.com or by phone at 858.276.0005.

Compassionate Use

Access to Investigational Medicines

Turning Point Therapeutics is committed to helping patients with cancer obtain access to new treatments. While we believe this is best accomplished through participation in clinical trials, we recognize that this is not always possible for every cancer patient. You can learn more about our ongoing clinical trials on our website or on ClinicalTrials.gov.

In some cases, we may be able to provide patients access to our investigational drugs outside of a clinical trial if certain conditions are met and if permitted by local law and regulation. The use of investigational drugs outside of a clinical trial is known as “Expanded Access” but may go by other names.

Expanded Access, also known as Compassionate Use, is the use of an investigational medical product prior to FDA approval and outside of use in a clinical trial. Turning Point accepts Single Patient Expanded Access requests for pre approval access to investigational drugs from physicians only.

Eligibility Requirements

Single Patient Expanded Access may not always be available and requires the individual patient meet certain eligibility conditions. To be eligible for access to an investigational medicine, a physician must apply and certify that the patient for whom the application is being submitted meets the following criteria:

  • Diagnosed with a serious, life-threatening or severely debilitating disease;.
  • Unable to participate in Turning Point Therapeutics clinical trials; and
  • Have no comparable or satisfactory alternative treatment option available.

In addition, we will consider providing Expanded Access only if the risk/benefit profile of the investigational drug is favorable in light of the sufficient safety and efficacy information and the treating physician’s assessment of the patient’s medical condition.

Turning Point is committed to a fair and impartial evaluation of each request, however, meeting the above criteria does not guarantee access to an investigational drug.

How to Apply

Physician requests can be submitted through our Compassionate Use portal.

Patients interested in obtaining access to a Turning Point investigational medicine must do so via their physician.

Review Process

Medical professionals at Turning Point Therapeutics will individually review each request, consistent with our policy on pre-approval access and the program eligibility requirements. Turning Point is committed to a fair and impartial evaluation of each request, however, meeting the above criteria does not guarantee access to an investigational drug.

This policy is subject to change.