SW-682 in Advanced Solid Tumors

Launched by SPRINGWORKS THERAPEUTICS, INC. · Feb 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called SW-682 for adults with advanced solid tumors, which are types of cancers that have spread or cannot be removed through surgery. It is specifically looking at patients whose cancer has either not responded to previous treatments like chemotherapy or immunotherapy, or for whom no other treatment options are available. The trial has two parts: the first part will find the right dosage of SW-682, and the second part will expand on that dosage for further testing. Participants will take SW-682 by mouth in cycles lasting 28 days.

To be eligible for this trial, participants must have a confirmed diagnosis of a certain type of advanced cancer, such as mesothelioma, and must have had previous treatments that did not work or were not tolerated. They should also have a specific genetic mutation that can be tested. Participants will need to provide a sample of their tumor tissue and be in good overall health with manageable side effects from their cancer. This trial is currently recruiting participants, and anyone considering joining will have the chance to try a new treatment option while contributing to research that could help others in the future.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 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
• * Part 1: must have one of the following:
• • 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).
• * Part 2: must have the tumor histology and oncogenic mutation or genomic aberration specific to each dose expansion cohort defined below:
• • Cohort 1: Participants with mesothelioma with or without NF2 mutations
• • Cohort 2: Participants with advanced solid tumors with NF2 mutations
• • Cohort 3: Participants with advanced solid tumors with other Hippo pathway mutations identified during Part 1 (Phase 1a) dose escalation
• • Cohort 4: SW-682 with appropriate combination therapy.
• • In both parts, participants should have known oncogenic mutation identified by Next Generation Sequencing or local assay
• • Must have archival tumor tissue or agree to a fresh tumor biopsy at screening
• • Measurable disease per RECIST 1.1
• • Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
• • Adequate bone marrow, kidney, hepatic, and coagulation function
• Key Exclusion Criteria:
• • 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
• • Concomitant medicines that are known strong/moderate inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) and/or CYP1A2 within 14 days or 5 half-lives before the first dose of study treatment
• • Concomitant medicines that are known sensitive substrates of CYP3A4, CYP2C19, CYP2D6, CYP1A2, and/or CYP2B6 within 14 days or 5 half-lives before the first dose of study treatment
• • Concomitant medicines that are known sensitive substrates of PGP, BCRP, OATP1B1, OATP1B3, OAT1, OAT3, MATE1, MATE2-K, OCT2
• • Clinically significant active infection (bacterial, fungal, or viral)