Recruiting

Phase 1

Phase 2

VT3989Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors

Sponsor:

Vivace Therapeutics, Inc

Code:

NCT04665206

Conditions

Solid Tumor, Adult

Mesothelioma

NSCLC

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VT3989

Nivolumab & Ipilimumab

Osimertinib

Pemetrexed/Carboplatin

Study Details

Brief 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

Solid Tumor, Adult

Mesothelioma

NSCLC

Study ID

NCT04665206

Start date

Mar 24, 2021

Status verified date

Mar, 2026

Completion date

Mar 2, 2030

Anticipated

Primary completion date

Nov 2, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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.
ECOG: 0-1.
Adequate organ functions, including the liver, kidneys, and hematopoietic system.

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
Known HIV positive or active Hepatitis B or Hepatitis C
Clinically significant cardiovascular disease and prior exposure to cardiotoxic agents.
Corrected QT (QTcF) interval > 470 msec (using Fridericia's correction formula).
Additional active malignancy that may confound the assessment of the study endpoints
Women who are pregnant or breastfeeding
Prior treatment with TEAD inhibitor.

Study Design

Enrollment

434 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

VT3989

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

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

Osimertinib

40 or 80 mg tablets for oral administration

Pemetrexed/Carboplatin

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

Primary outcome measure

Occurrence of Dose Limiting Toxicity [ Time Frame: over the first 21 days of dosing ]
Occurrence of General Toxicity [ Time Frame: through study completion, an average of 30 months ]

Central Contacts and Locations

Central contacts

Heather Fritz

650-627-7437 hfritz@inclin.com

Neelesh Sharma, MD

732-476-4978 nsharma@vivacetherapeutics.com

Locations

UCSF Helen Diller Family Comprehensive Cancer Center

Recruiting

San Francisco, California, United States, 94158

Contacts

Heather Fritz

650-627-7437 hfritz@inclin.com

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Heather Fritz

650-627-7437 hfritz@inclin.com

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Heather Fritz

650-627-7437 hfritz@inclin.com

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Heather Fritz

650-627-7437 hfritz@inclin.com

M Health Fairview University of Minnesota Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Heather Fritz

650-627-7437 hfritz@inclin.com

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Heather Fritz

650-627-7437 hfritz@inclin.com

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Heather Fritz

650-627-7437 hfritz@inclin.com

NEXT Oncology

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Heather Fritz

650-627-7437 hfritz@inclin.com

Virginia Cancer Specialists, PC

Recruiting

Arlington, Virginia, United States, 22201

Contacts

Heather Fritz

650-627-7437 hfritz@inclin.com

More Information

Sponsor

Vivace Therapeutics, Inc

Last update posted

Apr 2, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Vivace Therapeutics, Inc on 2026-04-02.