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Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors

ConditionsSolid Tumor, AdultMesotheliomaNSCLC
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVivace Therapeutics, Inc

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 have not received systemic chemotherapy.

Measurable disease per RECIST v1.1 for non-pleural mesothelioma or other solid tumors or modified RECIST v1.1 for malignant pleural mesothelioma. mRECIST may be used for pleural extension of non-pleural mesothelioma or for mixed pleural and peritoneal (or other) mesothelioma.

Disqualifiers

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

Known HIV positive or active Hepatitis B or Hepatitis C

Trial design

Design model

Sequential

Treatments tested in this trial

  • VT3989

    Drug

    25, 50, 100, 150 or 200 mg capsules for oral administration.

  • Nivolumab & Ipilimumab

    Drug

    Nivolumab infusion - 360 mg every 3 weeks, 30-minute intravenous infusion Ipilimumab infusion - 1 mg/kg every 6 weeks, 30-minute intravenous infusion

  • Osimertinib

    Drug

    40 or 80 mg tablets for oral administration

  • Pemetrexed/Carboplatin

    Drug

    Pemetrexed infusion: 500 mg/m2 intravenous infusion Carboplatin infusion: AUC 5.0 intravenous infusion

Treatment groups

434 Participants
are divided into 3 treatment groups
Group A: VT3989 Dose Escalation [Not Recruiting]Experimental treatment 1 intervention
Group B: Dose Expansion [Not Recruiting]Experimental treatment 1 intervention
Group C: Combination [Recruiting]Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Occurrence of Dose Limiting Toxicity

Incidence of Adverse and Serious Adverse Events

Time frame
over the first 21 days of dosing
2

Occurrence of General Toxicity

Incidence of Adverse and Serious Adverse Events, Discontinuations due to Adverse Events and general safety evaluations

Time frame
through study completion, an average of 30 months

Secondary outcomes

1

Tumor Response

Determined by RECIST v1.1 or modified RECIST v1.1

Time frame
through study completion, an average of 30 months
2

Pharmacokinetic Evaluation - Cmax

Peak plasma concentration of VT3989

Time frame
for first 6 cycles
3

Pharmacokinetic Evaluation - Tmax

Time to reach peak plasma concentration of VT3989

Time frame
for first 6 cycles
4

Pharmacokinetic Evaluation - Half-life

Time required for the plasma concentration of VT3989 to reduce by half after reaching peak

Time frame
for first 6 cycles

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vivace Therapeutics, Inc

Lead sponsor

Source ClinicalTrials.gov
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