Patients

Rain Therapeutics Clinical Trials

A clinical trial is a controlled study where an experimental drug or device is tested in humans. The purpose of a clinical trial is to evaluate the safety and efficacy (how well it works) of an experimental drug or device. To participate in a clinical trial, you must meet all eligibility criteria and be willing to following the directions of the study doctor.

Rain is currently conducting a Phase 2 clinical trial studying tarloxotinib (Tarlox) in non-small cell lung cancer (NSCLC) patients with EGFR Exon 20 or HER2-activating mutations and other advanced solid tumors with NRG1/ERBB family gene fusions. To learn more about NSCLC, EGFR/HER2 mutations, NRG1/ERBB fusions, Tarlox and details about the clinical trial, continue reading below. If you have any additional questions, you can contact the study center in your area.

Non-Small Cell Lung Cancer (NSCLC)

Non-small cell lung cancer is a specific kind of lung cancer. Treatment options can include surgery, radiation and chemotherapy depending on the stage, however, there are targeted treatment strategies currently in development that have the potential to be safer and more effective.

Rain Therapeutics is currently developing a targeted therapy (Tarlox) specifically for certain types of EGFR and HER2 mutations in NSCLC.

    NSCLC includes the following subtypes:
  • Adenocarcinoma
  • Squamous cell carcinoma
  • Adenosquamous carcinoma
  • Large Cell Carcinoma
  • Other Histologies

EGFR Exon 20 and HER2 Mutations

EGFR Exon 20 or HER2 gene mutations induce abnormal activation of these proteins in lung cancer cells that drives the growth of tumors. It is estimated that 2% to 5% of NSCLC tumors have either EGFR Exon 20 or HER2-activating mutations. Currently there are no FDA-approved therapies specifically for EGFR Exon 20 or activating mutations in NSCLC. It is often difficult to treat patients whose cancer is caused by these mutations – currently available treatments are sometimes associated with side-effects that prevent doctors from effectively treating the cancer.

NRG1 / ERBB Fusions

NRG1 or EGFR gene fusions, EGFR kinase domain duplications, ERBB2 (HER2) gene fusions, and ERBB4 (HER4) gene fusions induce abnormal activation of these proteins in cancer cells that drives the growth of tumors. It is estimated that 1% of solid tumors have these fusions. There are no FDA-approved therapies specifically for these mutations. It is often difficult to treat patients whose cancer is caused by these mutations – currently available treatments are sometimes associated with side-effects that prevent doctors from effectively treating the cancer.

Tarloxotinib

Tarloxotinib (Tarlox) is a targeted therapy that inhibits EGFR and HER2. It is unique because it is a prodrug, which means that it remains inactive until it is triggered to convert into the active drug. Specifically, Tarlox converts to its active form in the tumor itself and remains inactive in most other tissues in the body. Because it is targeted specifically at EGFR and HER2 and because it is activated in the tumor, Tarlox has the potential to be safer and more effective than other drugs of its kind.

See the video where Rain co-founder Dr. Robert Doebele explains how Tarlox works here

Details about the Clinical Trial

Rain Therapeutics is currently conducting a clinical trial for patients suffering from NSCLC with EGFR Exon 20 and HER2-activating mutations and other advanced solid tumors with NRG1/ERBB family gene fusions.

  • This study will enroll approximately 85 people in the United States, Canada and Hong Kong
  • Tarlox will be given as a weekly intravenous (IV) infusion
  • People can continue to receive Tarlox infusions until their cancer progresses or until they develop toxicities
  • There is an observation period following each infusion where people will need to remain at the study site
  • People on the study will need to have frequent tumor assessments
  • Blood will be collected to test how Tarlox is affecting your body

For a full description of the study, or for details about the clinical trial, please select one of the options below.

RAIN-701 Clinical Study


A Phase 2 Study to Evaluate the Clinical Activity of Tarloxotinib in Patients with Non‑Small Cell Lung Cancer that Harbors Either an EGFR Exon 20 Insertion or a HER2‑Activating Mutation and Other Advanced Solid Tumors with NRG1/ERBB Family Gene Fusions or a HER2‑Activating Mutation

Additional Resources

If you or a loved one has recently been diagnosed with NSCLC, you can find some additional resources below.

National Cancer Hotline: 800.227.2345

Exon 20/HER2 Group
EGFR Resisters
Cancer Grace