Phase I/II, Multi-Center, Open-Label Study of VT3989, Alone or in Combination, in Patients With Locally Advanced or Metastatic Solid Tumors
Vivace Therapeutics, Inc
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.
Description
Dose escalation (Part 1) will employ a traditional 3 + 3 design to assess safety of VT3989 in patients with metastatic solid tumors or mesothelioma. The 3 + 3 design will be implemented until the MTD or recommended phase 2 dose(s) and schedule(s) are determined. The MTD is defined as the highest dose level at which \< 33% of patients experience a dose limiting toxicity (DLT) during the first cycle of the study (Cycle 1). Dose Expansion (Part 2) will further evaluate the safety and assess preliminary antitumor activity at the recommended phase 2 dose(s) and schedule(s) with up to 6 cohorts. Ex…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugVT3989
25, 50, 100, 150 or 200 mg capsules for oral administration.
- DrugNivolumab & Ipilimumab
Nivolumab infusion - 360 mg every 3 weeks, 30-minute intravenous infusion Ipilimumab infusion - 1 mg/kg every 6 weeks, 30-minute intravenous infusion
- DrugOsimertinib
40 or 80 mg tablets for oral administration
- DrugPemetrexed/Carboplatin
Pemetrexed infusion: 500 mg/m2 intravenous infusion Carboplatin infusion: AUC 5.0 intravenous infusion
Locations (12)
- UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California
- University of Chicago Medical CenterChicago, Illinois
- Massachusetts General HospitalBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts
- M Health Fairview University of Minnesota Medical CenterMinneapolis, Minnesota
- Memorial Sloan Kettering Cancer CenterNew York, New York