SW-682 in Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
About this trial
This is a first-in-human (FIH), Phase 1a/1b open-label, multicenter, dose escalation and dose expansion study of SW-682 in adult participants with metastatic or unresectable advanced solid tumors with or without Hippo pathway alterations that are refractory to, or have progressed, during or after appropriate prior systemic anticancer therapy, including chemotherapy, immunotherapy, radiation therapy or targeted therapy, or for which no treatment is available, or prior standard of care (SOC) therapy was not tolerated and for which there is no further SOC treatment available. The study includes a Part 1 (Phase 1a) dose escalation phase and a Part 2 (Phase 1b) dose expansion to optimize the dose to be used for further development. All participants will self-administer SW-682 by mouth in 28-day cycles.
Eligibility criteria
Qualifiers
Histologically confirmed, metastatic, or unresectable solid cancer that has either not responded to or progressed during or after appropriate prior systemic anticancer therapy including chemotherapy, immunotherapy, radiation therapy, or appropriate targeted therapy, or for which there is no treatment available or prior SOC therapy was not tolerated and for which there is no further SOC treatment available
Mesothelioma with or without NF2 mutations
Advanced solid tumors with NF2 mutations
Advanced solid tumors with other Hippo pathway mutations or fusions (e.g., FAT1, LATS1/2, YAP fusions; WWTR1-CAMTA1 in EHE).
Disqualifiers
Evidence of symptomatic CNS metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression
Clinically significant cardiac disease or abnormal cardiac parameters
Preexistence or inheritance of a familial renal syndrome
Concomitant non-anti-arrhythmic medications that are known to prolong the QTc interval
Trial design
Treatments tested in this trial
- SW-682
- Combination Therapy
Treatment groups
186 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov