Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors Enriched for Tumors With NF2 Gene Mutations
- Interventional
- Recruiting
- NCT04665206
Contact Information
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
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.
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.
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.
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers?
No
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
- 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
- Mesothelioma
- Solid Tumors