A Phase 3 Trial in Advanced Epithelioid Mesothelioma

What this trial studies

Approximately 350 participants will be randomized 1:1 to VT3989 (Arm A) or Investigator's choice chemotherapy with gemcitabine or vinorelbine (Arm B). VT3989 will be administered orally at 100 mg once daily for 2 weeks on treatment followed by 2 weeks off treatment in each 4-week cycle. Comparator treatment will be gemcitabine or vinorelbine using the protocol-specified regimen or local prescribing/institutional practice. The trial includes screening, treatment, safety follow-up, and survival follow-up periods. A QTc Sub-Study will evaluate cardiac repolarization using time-matched pharmacokinetic samples and ECGs in approximately 25 Arm A participants. Overall survival is the primary endpoint; BICR-assessed progression-free survival is the key secondary endpoint.

Who can join: the full rules

Inclusion Criteria:

* 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.

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).
* 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.

Study contacts

• Study coordinator: Arick Wong
• Email: vt3989-003@vivacetherapeutics.com
• Phone: 650-666-2753

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating VT3989 for patients with metastatic solid tumors

  This study is testing a new drug called VT3989 to see if it can help people with hard-to-treat metastatic solid tumors, including mesothelioma, feel better and fight their cancer.

  Recruiting at 12 sites Phase 1/2 Vivace Therapeutics, Inc · San Francisco, California and 11 other locations · NCT04665206

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.