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

No results posted yet for this study

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

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

Osimertinib

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04665206 on ClinicalTrials.gov