Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVivace Therapeutics, Inc
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- VT3989
- Nivolumab & Ipilimumab
- Osimertinib
- Pemetrexed/Carboplatin
Treatment groups
434 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov