Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors

About this trial

Last updated 2 months ago

Study ID

VT3989-001

Status

Recruiting

Type

Interventional

Phase

Phase 1

Placebo

Accepting

18+ Years

All Sexes

Trial Timing

Started 5 years ago

What is this trial about?

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.

What are the participation requirements?

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.