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Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors
Trial Status: active
This is an open-label, dose escalation and expansion study to evaluate the safety,
tolerability, PK, and biological activity of VT3989 administered, alone or in
combination, once daily in patients with mesothelioma and/or metastatic solid tumors that
are resistant to standard therapy or for which no effective standard therapy is
available.
Inclusion Criteria
Part 3 Combination Cohort A: Patients with pathologically diagnosed, metastatic or unresectable malignant mesothelioma (including both pleural and non-pleural) who have not received systemic therapy.
Part 3 Combination Cohort B: Patients with pathologically diagnosed incurable locally advanced (inoperable or recurrent), or metastatic NSCLC with exon 19 deletions or exon 21 L858R mutations, with or without prior treatment with Osimertinib.
Measurable disease per RECIST v1.1 for non-pleural mesothelioma or other solid tumors or modified RECIST v1.1 for malignant pleural mesothelioma. mRECIST may be used for pleural extension of non-pleural mesothelioma or for mixed pleural and peritoneal (or other) mesothelioma.
ECOG: 0-1.
Adequate organ functions, including the liver, kidneys, and hematopoietic system.
Exclusion Criteria
Active brain metastases or primary CNS (central nervous system) tumors.
History of leptomeningeal metastases
Active or chronic, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
Known HIV positive or active Hepatitis B or Hepatitis C
Clinically significant cardiovascular disease
Corrected QT (QTcF) interval > 470 msec (using Fridericia's correction formula); except for Part 2 Expansion Cohort 3, the QTcF interval criteria is > 450 msec).
Additional active malignancy that may confound the assessment of the study endpoints
Women who are pregnant or breastfeeding
Prior treatment with TEAD inhibitor, except for EHE patients.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04665206.
