Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors

Part of paid clinical trials in San Francisco, California.

Sponsor
Vivace Therapeutics, Inc
Study ID
NCT04665206
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Mesothelioma
  • NSCLC
  • Solid Tumor, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Mar 24, 2021
Status verified
Mar 2026
Primary completion
Nov 2, 2029
Completion
Mar 2, 2030

Study Design

Enrollment
434 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: VT3989 Dose Escalation [Not Recruiting]
    VT3989 dosed orally in 21 or 28 day cycles. Patients will be enrolled into escalating dose levels during the Dose Escalation Phase
  • Experimental: Dose Expansion [Not Recruiting]
    VT3989 dosed in 21 or 28 day cycles in patients with refractory metastatic solid tumors or mesothelioma.
  • Experimental: Combination [Recruiting]
    For Cohort A and B, VT3989 dosed in 28 day cycles in patients with metastatic solid tumors or mesothelioma, in combination with immunotherapy (nivolumab/ipilimumab) or targeted therapy (osimertinib). For Cohort C, VT3989 dosed in 21 day cycles in patients with mesothelioma in combination with chemotherapy (pemetrexed+carboplatin) for 4-6 cycles, then continuing VT3989 as monotherapy on 28-day cycle.

Primary Outcome Measure

Occurrence of Dose Limiting Toxicity [ Time Frame: over the first 21 days of dosing ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
UCSF Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94158
Heather Fritz
[email protected]
650-627-7437
University of Chicago Medical CenterChicagoIllinois60637
Heather Fritz
[email protected]
650-627-7437
Dana-Farber Cancer InstituteBostonMassachusetts02215
Heather Fritz
[email protected]
650-627-7437
Massachusetts General HospitalBostonMassachusetts02114
Heather Fritz
[email protected]
650-627-7437
M Health Fairview University of Minnesota Medical CenterMinneapolisMinnesota55455
Heather Fritz
[email protected]
650-627-7437
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Heather Fritz
[email protected]
650-627-7437
MD Anderson Cancer CenterHoustonTexas77030
Heather Fritz
[email protected]
650-627-7437
NEXT OncologySan AntonioTexas78229
Heather Fritz
[email protected]
650-627-7437
Virginia Cancer Specialists, PCArlingtonVirginia22201
Heather Fritz
[email protected]
650-627-7437

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By research site
UCSF Helen Diller Family Comprehensive Cancer Center· San Francisco, CAUniversity of Chicago Medical Center· Chicago, ILDana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MAM Health Fairview University of Minnesota Medical Center· Minneapolis, MNMemorial Sloan Kettering Cancer Center· New York, NY

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