At a glance
ClinicalIndex Comparison Record- ✓Pathologically diagnosed, metastatic or unresectable malignant mesothelioma (pleural or non-pleural), no prior systemic therapy (Cohort A)
- ✓Pathologically diagnosed incurable locally advanced (inoperable or recurrent) or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations, with or without prior osimertinib (Cohort B)
- ✓Pathologically diagnosed metastatic or unresectable malignant pleural mesothelioma, no prior systemic chemotherapy (Cohort C)
- ✓Measurable disease per RECIST v1.1 or modified RECIST v1.1 for pleural mesothelioma
- ✕Active brain metastases or primary CNS tumors
- ✕History of leptomeningeal metastases
- ✕Active or chronic uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
- ✕Known HIV positive or active Hepatitis B or Hepatitis C
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I/II, Multi-Center, Open-Label Study of VT3989, Alone or in Combination, in Patients With Locally Advanced or Metastatic Solid Tumors
In Brief
A Phase 2 clinical trial evaluating VT3989, Nivolumab & Ipilimumab, and 2 other interventions for Solid Tumor, Adult and 2 related conditions. Currently recruiting, targeting 434 participants across 12 sites in 2 countries.
Signals
Detailed Summary
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.
Study Details
Timeline
Interventions
25, 50, 100, 150 or 200 mg capsules for oral administration.
Nivolumab infusion - 360 mg every 3 weeks, 30-minute intravenous infusion Ipilimumab infusion - 1 mg/kg every 6 weeks, 30-minute intravenous infusion
40 or 80 mg tablets for oral administration
Pemetrexed infusion: 500 mg/m2 intravenous infusion Carboplatin infusion: AUC 5.0 intravenous infusion