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Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors Enriched for Tumors With NF2 or mNF2 Gene Mutations

PHASE1PHASE2RECRUITING

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 3- or 4-week cycles in patients with mesothelioma and/or metastatic solid tumors that are resistant or refractory to standard therapy or for which no effective standard therapy is available.

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Study details:

Dose escalation will employ a traditional 3 + 3 design to assess safety of VT3989 in patients with refractory 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 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 using optimal 2-stage Simon designs. Expansion cohorts 1 and 2 will enroll patients with mesothelioma of any site origin with or without NF2 mutations. Expansion cohort 3 will enroll non-pleural mesothelioma patients.

Expansion cohort 4 will enroll solid tumor patients with clearly inactivating NF2 mutations/alterations or YAP/TAZ gene rearrangements.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Part 1: pathologically diagnosed metastatic solid tumor or mesothelioma that has progressed on or after all approved therapies of known clinical benefit except if the patient refuses or is not a candidate for such therapy;

Part 2: In mesothelioma cohorts, pathologically diagnosed advanced malignant mesothelioma with or without NF2 mutations, that has progressed on or after all approved therapies of known clinical benefit except if the patient refuses or is not a candidate for such therapy. In the solid tumor cohort, pathologically diagnosed solid tumor with with clearly inactivating NF2 mutations/alterations or YAP/TAZ gene rearrangements, which have progressed on or after approved therapies of known clinical benefit except if the patient refuses or is not a candidate for such therapy.

Measurable disease per RECIST v1.1 for non-pleural mesothelioma or other solid tumors (solid tumor expansion cohort) or modified RECIST v1.1 for malignant pleural mesothelioma.

ECOG: 0-1

Exclusion criteria

Active brain metastases or primary CNS (central nervous system) tumors.

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

Prior treatment with TEAD inhibitor

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2021-03-24

Primary completion: 2026-12-24

Study completion finish: 2027-06-02

Study type

TREATMENT

Phase

PHASE1

PHASE2

Trial ID

NCT04665206

Intervention or treatment

DRUG: VT3989

Conditions

• Solid Tumor, Adult
• Mesothelioma

Condition: Solid Tumor, Adult, Mesothelioma
DRUG: VT3989
Clayton, Victoria, Australia and more
Sponsor: Vivace Therapeutics, Inc

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Monash Health

Research sites nearby

Select from list below to view details:

Monash Health
Clayton, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Peter MacCullum Cancer Centre
Melbourne, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: VT3989 Dose Escalation VT3989 dosed orally in 21 or 28 day cycles. Patients will be enrolled into escalating dose levels during the Dose Escalation Phase	DRUG: VT3989 25, 50, 100,150 or 200 mg capsules for oral administration.
EXPERIMENTAL: Dose Expansion VT3989 dosed in 21 or 28 day cycles in patients with refractory metastatic solid tumors or mesothelioma, with or without NF2 mutant tumors.	DRUG: VT3989 25, 50, 100,150 or 200 mg capsules for oral administration.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Occurrence of Dose Limiting Toxicity	Incidence of Adverse and Serious Adverse Events	over the first 21 days of dosing
Occurrence of General Toxicity	Incidence of Adverse and Serious Adverse Events, Discontinuations due to Adverse Events and general safety Evaluations	through study completion, an average of 30 months

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Tumor Response	Determined by RECIST v1.1 or modified RECIST v1.1	through study completion, an average of 30 months
Pharmacokinetic Evaluation - Cmax	Peak plasma concentration of VT3989	over first 21 days of dosing
Pharmacokinetic Evaluation - Tmax	Time to reach peak plasma concentration of VT3989	over first 21 days of dosing
Pharmacokinetic Evaluation - Half-life	Time required for the plasma concentration of VT3989 to reduce by half after reaching peak	over first 21 days of dosing

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

Clinical Trials Gov: Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors Enriched for Tumors With NF2 or mNF2 Gene Mutations