Description:
This is an open-label, dose escalation and expansion study to evaluate the safety,
tolerability, PK, and biological activity of VT3989 administered once-daily in patients with
advanced pleural malignant mesothelioma and/or metastatic solid tumors that are resistant or
refractory to standard therapy or for which no effective standard therapy is available.
Title
- Brief Title: Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors Enriched for Tumors With NF2 Gene Mutations
- Official Title: Phase 1, Multi-Center, Open-Label, Study to Evaluate the Safety, Tolerability, and PK of VT3989 in Patients With Refractory Locally Advanced or Metastatic Solid Tumors Enriched for Tumors Harboring Mutations of the NF2 Gene
Clinical Trial IDs
- ORG STUDY ID:
VT3989-001
- NCT ID:
NCT04665206
Conditions
- Solid Tumor, Adult
- Mesothelioma
Interventions
Drug | Synonyms | Arms |
---|
VT3989 | | Dose Expansion |
Purpose
This is an open-label, dose escalation and expansion study to evaluate the safety,
tolerability, PK, and biological activity of VT3989 administered once-daily in patients with
advanced pleural malignant mesothelioma and/or metastatic solid tumors that are resistant or
refractory to standard therapy or for which no effective standard therapy is available.
Detailed Description
Dose escalation will employ a traditional 3 + 3 design to assess safety of VT3989 in patients
with refractory metastatic solid tumors or advanced malignant pleural mesothelioma until the
maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is determined. The RP2D may
be less than the MTD depending on the type and severity of AEs that occur during and after
the first cycle.
In Dose Expansion, patients will be enrolled into 2 cohorts: Cohort 1 - malignant pleural
mesothelioma patients with mutations of NF2 that have progressed on or following standard
therapy; and Cohort 2 - solid tumor patients with mutations of NF2 that have progressed on or
following standard therapy. Patients will be treated at the MTD or RP2D identified in Part 1,
to provide further characterization of the safety, tolerability, efficacy, and biological
activity of VT3989.
Trial Arms
Name | Type | Description | Interventions |
---|
VT3989 Dose Escalation | Experimental | VT3989 dosed orally once per day in 21 day cycles. Patients will be enrolled into escalating dose levels during the Dose Escalation Phase | |
Dose Expansion | Experimental | VT3989 dosed once per day in 21 day cycles in patients with refractory metastatic solid tumors, or advanced pleural malignant mesothelioma, with NF2 mutant tumors. | |
Eligibility Criteria
Inclusion Criteria:
- Part 1: pathologically diagnosed metastatic solid tumor or advanced malignant pleural
mesothelioma that has progressed on or after standard of care therapy with evaluable
or measurable disease per RECIST v1.1
- Part 2: pathologically diagnosed advanced malignant pleural mesothelioma with NF2
mutations (Cohort 1) or metastatic solid tumors with NF2 mutation (Cohort 2), for
which there is no further standard of care therapy available with measurable disease
per RECIST v1.1 for solid tumors or modified RECIST v1.1 for malignant pleural
mesothelioma
- ECOG: 0-1
Exclusion Criteria:
- Active brain metastases
- History of leptomeningeal metastases
- Active or chronic, uncontrolled bacterial, viral, or fungal infection(s) requiring
systemic therapy
- HIV positive or active Hepatitis B or Hepatitis C
- Clinically significant cardiovascular disease
- Additional active malignancy that may confound the assessment of the study endpoints
- Women who are pregnant or breastfeeding
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Occurrence of Dose Limiting Toxicity |
Time Frame: | over the first 21 days of dosing |
Safety Issue: | |
Description: | Incidence of Adverse and Serious Adverse Events |
Secondary Outcome Measures
Measure: | Tumor Response |
Time Frame: | through study completion, an average of 30 months |
Safety Issue: | |
Description: | Determined by RECIST v1.1 or modified RECIST v1.1 |
Measure: | Pharmacokinetic Evaluation - Cmax |
Time Frame: | over first 21 days of dosing |
Safety Issue: | |
Description: | Peak plasma concentration of VT3989 |
Measure: | Pharmacokinetic Evaluation - Tmax |
Time Frame: | over first 21 days of dosing |
Safety Issue: | |
Description: | Time to reach peak plasma concentration of VT3989 |
Measure: | Pharmacokinetic Evaluation - Half-life |
Time Frame: | over first 21 days of dosing |
Safety Issue: | |
Description: | Time required for the plasma concentration of VT3989 to reduce by half after reaching peak |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Vivace Therapeutics, Inc |
Last Updated
April 23, 2021