Our Clinical Trials

SpringWorks Therapeutics is conducting clinical trials to evaluate the safety and efficacy of our investigational therapies, both alone and in combination with other therapies, for patients with rare tumors and advanced solid tumors.

For more information, follow the links below to the study listings on clinicaltrials.gov. Medical professionals may also email us at clinical@springworkstx.com for more information about study participation. Patients and families should speak to their physician to ask about whether a study is right for them.


Nirogacestat: Desmoid Tumors

SpringWorks is enrolling patients in a Phase 3 trial for patients with desmoid tumors, which are rare and debilitating soft-tissue tumors that can cause severe pain and disfigurement.

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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Nirogacestat: Relapsed/Refractory Multiple Myeloma

Under a global clinical trial agreement with GlaxoSmithKline, a Phase 1b clinical trial is evaluating the safety, tolerability and preliminary efficacy of nirogacestat in combination with belantamab mafodotin, an anti-B-cell maturation antigen (BCMA) antibody-drug conjugate (ADC), in patients with relapsed or refractory multiple myeloma. This combination is part of DREAMM-5, a platform trial being conducted by GlaxoSmithKline that is evaluating multiple belantamab mafodotin-containing combinations in separate sub-studies.

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Mirdametinib: Neurofibromatosis Type 1-Associated Plexiform Neurofibromas

SpringWorks is enrolling patients in a Phase 2b trial for patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN), which are rare and devastating tumors that can cause severe pain, disfigurement and functional impairment.

The ReNeu trial is evaluating mirdametinib, an oral small molecule designed to inhibit MEK1 and MEK2, in patients two years of age and older with an inoperable NF1-PN causing significant morbidity.

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Mirdametinib + Lifirafenib: Advanced or Refractory Solid Tumors that Harbor RAS Mutations, RAF Mutations or Other MAPK Pathway Aberrations

Patients with advanced or refractory solid tumors that harbor RAS mutations, RAF mutations and other MAPK pathway aberrations are being enrolled in a Phase 1b trial.

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.

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

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BGB-3245: Advanced or Refractory Solid Tumors that Harbor Specific B-RAF Driver Mutations and Fusions

Patients with advanced or refractory solid tumors harboring specific B-RAF driver mutations and fusions that are likely to respond to a RAF dimer inhibitor, as well as patients who have developed resistance to first-generation B-RAF V600 inhibitors, are being enrolled in a Phase 1 trial.

The study is evaluating the safety, pharmacokinetics and antitumor activity of BGB-3245, an investigational, selective, next-generation B-RAF inhibitor, in this patient population.

BGB-3245 is being advanced by MapKure, an entity jointly owned by SpringWorks and BeiGene.

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