Our Clinical Trials

Clinical trials are studies that collect data to determine if a new drug is safe and effective. They are essential research practices for advancing science, enhancing medical knowledge, and developing new treatment options to improve patient care. Each clinical trial is different and follows a plan known as a protocol, which is carefully designed and usually reviewed and approved by the U.S. Food and Drug Administration (FDA) and other relevant government agencies outside the U.S.

SpringWorks is conducting several clinical trials to evaluate the safety and efficacy of our investigational therapies, both alone and in combination with other therapies, for patients with rare tumor types and other more prevalent, genetically defined tumors.

Below is information on our ongoing trials. For additional information on our trials, medical professionals may also email SpringWorks at clinical@springworkstx.com. Patients and families should speak to their physicians to ask about whether a study may be right for them and to understand the eligibility criteria that must be met in order to participate in each study. For those who do not meet eligibility criteria, you may be able to participate in our Expanded Access Program.

Desmoid Tumors

Patients are being enrolled in a Phase 3 clinical trial (“DeFi”) evaluating nirogacestat in adults with desmoid tumors. Desmoid tumors are rare and often debilitating and disfiguring soft-tissue tumors.

DeFi clinical trial logo

The DeFi trial is evaluating nirogacestat, an oral, selective, small molecule gamma-secretase inhibitor in adult patients with progressing desmoid tumors.

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Advanced or Refractory Solid Tumors that Harbor RAS Mutations, RAF Mutations or Other MAPK Pathway Aberrations

Mirdametinib + Lifirafenib
Patients are being enrolled in a Phase 1b study evaluating mirdametinib, a MEK inhibitor, in combination with lifirafenib, a RAF dimer inhibitor, in patients with advanced or refractory solid tumors harboring RAS mutations, RAF mutations, and other MAPK pathway aberrations.

SpringWorks Logo

The study is evaluating the safety, tolerability and preliminary efficacy of combining BeiGene’s investigational RAF dimer inhibitor, lifirafenib (BGB-283) and SpringWorks Therapeutics’ investigational MEK inhibitor, mirdametinib, in patients with advanced solid tumors.

BeiGene logo

The trial is being administered by BeiGene under a global clinical collaboration agreement between SpringWorks and BeiGene.

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