A Phase 3 Trial in Advanced Epithelioid Mesothelioma

NCT07824986 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: VT3989-003
• Study Type: interventional
• Target: 350
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized, open-label, multicenter Phase 3 trial will compare VT3989 with Investigator's choice of gemcitabine or vinorelbine in adults with advanced epithelioid pleural mesothelioma whose disease progressed after prior platinum-based systemic chemotherapy and immunotherapy.

Conditions

Pleural Mesothelioma; Mesothelioma

Keywords

Mesothelioma

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Time from randomization to death from any cause. Participants without an observed death will be censored at the last date known alive or the analysis cut-off date, whichever is earlier.

  Approximately 32-35 months after first randomization

Secondary Outcomes (10)

• Progression-Free Survival by BICR

  From randomization through radiologic progression, death, up to approximately 3 years or more

• Treatment-Emergent Adverse Events and Serious Adverse Events

  From first dose through the safety follow-up visit, (28 days after the last dose), up to approximately 3 years or more.

• Disease-related symptoms and health-related quality of life outcomes

  Baseline through treatment and protocol-specified follow-up; up to approximately 3 years or more

• Overall Response Rate by BICR

  Tumor assessments during treatment and applicable follow-up; up to approximately 3 years or more

• Duration of Response

  From first documented response through progression, death, or analysis cut-off; up to approximately 3 years or more

Other Outcomes (3)

• Pharmacokinetic Evaluation - Cmax

  Up to Cycle 9 (each cycle is 28 days)

• Pharmacokinetic Evaluation - AUC

  Up to Cycle 9 (each cycle is 28 days)

• Correlation between VT3989 exposure

  Up to Cycle 9 (each cycle is 28 days)

Study Arms (2)

Arm A - VT3989

EXPERIMENTAL

VT3989 monotherapy in 28-day cycles until BICR-verified progression, unacceptable toxicity, withdrawal, or another protocol-specified reason.

Drug: VT3989

Arm B - Investigator's Choice Chemotherapy

ACTIVE COMPARATOR

The Investigator selects 21-day cycle of gemcitabine or vinorelbine. Administration and dose modification may follow the protocol, local prescribing information, or institutional practice.

Drug: gemcitabine; Drug: Vinorelbine

Interventions

VT3989 DRUG

• 100 mg orally once daily for 2 weeks on treatment followed by 2 weeks off treatment (2W/2W) in each 4-week cycle

Arm A - VT3989

gemcitabine DRUG

• 1,000 mg/m2 IV on Days 1 and 8 of each 3-week cycle, or per local prescribing information/institutional practice

Arm B - Investigator's Choice Chemotherapy

Vinorelbine DRUG

• 25-30 mg/m2 IV on Days 1 and 8 of each 3-week cycle, or per local prescribing information/institutional practice

Arm B - Investigator's Choice Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age 18 years or older at informed consent.
• Pathologically confirmed advanced epithelioid pleural mesothelioma previously treated with platinum-based systemic chemotherapy and immunotherapy, given sequentially or concurrently.
• Radiologically measurable disease by modified RECIST v1.1 or RECIST v1.1.
• ECOG: 0-1.
• Adequate organ functions, including the liver, kidneys, and hematopoietic system.

You may not qualify if:

• 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).
• Women who are pregnant or breastfeeding
• Non-pleural mesothelioma at initial diagnosis or an aggressive histologic type such as sarcomatoid or biphasic mesothelioma.
• Prior treatment with a TEAD inhibitor, including VT3989 or another agent targeting the same molecular pathway.
• Prior receipt of both comparator treatments, gemcitabine and vinorelbine, alone or in combination, or known hypersensitivity to both. A participant who received only one comparator may enroll but must not be assigned to that same comparator.

Sponsors & Collaborators

• Vivace Therapeutics, Inc: lead

MeSH Terms

Conditions

Mesothelioma, Malignant; Mesothelioma

Interventions

Gemcitabine; Vinorelbine

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Central Study Contacts

Arick Wong

CONTACT

650-666-2753; vt3989-003@vivacetherapeutics.com

Dereck Amakye

CONTACT

650-666-2753; info@vivacetherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized 1:1 to VT3989 or Investigator's choice chemotherapy (gemcitabine or vinorelbine).

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 17, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): January 1, 2031
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share