Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors
NCT04665206 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 434
Last updated 2026-04-02
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.
Conditions
- Solid Tumor, Adult
- Mesothelioma
- NSCLC
Interventions
- DRUG
-
VT3989
25, 50, 100, 150 or 200 mg capsules for oral administration.
- DRUG
-
Nivolumab & Ipilimumab
Nivolumab infusion - 360 mg every 3 weeks, 30-minute intravenous infusion Ipilimumab infusion - 1 mg/kg every 6 weeks, 30-minute intravenous infusion
- DRUG
-
40 or 80 mg tablets for oral administration
- DRUG
-
Pemetrexed/Carboplatin
Pemetrexed infusion: 500 mg/m2 intravenous infusion Carboplatin infusion: AUC 5.0 intravenous infusion
Sponsors & Collaborators
-
Vivace Therapeutics, Inc
lead INDUSTRY
Principal Investigators
-
Neelesh Sharma, MD · Vivace Therapeutics
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-03-24
- Primary Completion
- 2029-11-02
- Completion
- 2030-03-02
- FDA Drug
- Yes
Countries
- United States
- Australia
Study Locations
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