Trial NCT04665206
Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors
- Phase
- Phase 1/2
- Sponsor
- Vivace Therapeutics, Inc
- Conditions
- Solid Tumor, Adult; Mesothelioma; NSCLC
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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.
* Part 3 Combination Cohort C: Patients with pathologically diagnosed metastatic or unresectable malignant pleural mesothelioma who have not received systemic chemotherapy.
* 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.Performance status
* Adequate organ functions, including the liver, kidneys, and hematopoietic system.
Exclusion Criteria:
* Active brain metastases or primary CNS (central nervous system) tumors.Brain metastases
* 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 CHIV
* Clinically significant cardiovascular disease and prior exposure to cardiotoxic agents.
* Corrected QT (QTcF) interval > 470 msec (using Fridericia's correction formula).Cardiac
* Additional active malignancy that may confound the assessment of the study endpointsPrior malignancy
* Women who are pregnant or breastfeedingPregnancy
* Prior treatment with TEAD inhibitor.
Restrictions found (6)
- Brain metastasesOutrightexclusionShow in the text
- CardiacOutrightexclusion
QTcF > 470 msec
Show in the text - HIVOutrightexclusionShow in the text
- Performance statusOutrightinclusion
ECOG 0-1
Show in the text - PregnancyOutrightexclusionShow in the text
- Prior malignancyConditionalexclusionShow in the text
Recruiting in Massachusetts
- Massachusetts General Hospital · Boston, Suffolk County
- Dana-Farber Cancer Institute · Boston, Suffolk County