Study to Evaluate VT3989 in Patients with Metastatic Solid Tumors

Launched by VIVACE THERAPEUTICS, INC · Dec 10, 2020

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called VT3989 for patients with advanced solid tumors, including mesothelioma, that have not responded to standard therapies. The study is designed to see how safe and effective VT3989 is when taken daily in cycles of 3 or 4 weeks. Researchers are particularly interested in patients whose tumors have specific genetic changes known as NF2 mutations, which may affect how the tumors respond to treatment.

To be eligible for this trial, participants should have a confirmed diagnosis of metastatic solid tumors or mesothelioma that has worsened despite other treatments. They should also have measurable disease, meaning their tumors can be evaluated for changes during the study. However, patients with certain conditions like active brain tumors, uncontrolled infections, or those who are pregnant or breastfeeding cannot participate. Those who join the study can expect regular check-ups and monitoring to assess their response to the treatment and any side effects. This trial is currently recruiting participants and aims to provide new options for patients with limited treatment choices.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Part 1: pathologically diagnosed metastatic solid tumor or mesothelioma that has progressed on or after all approved therapies of known clinical benefit except if the patient refuses or is not a candidate for such therapy;
• • Part 2 Expansion Cohorts 1 and 2: in mesothelioma cohorts, pathologically diagnosed advanced malignant mesothelioma with or without NF2 mutations, that has progressed on or after all approved therapies of known clinical benefit except if the patient refuses or is not a candidate for such therapy.
• • Part 2 Expansion Cohort 3: non-pleural mesothelioma patients with epithelioid histology, relapsed from or refractory to prior platinum-based chemotherapy and immunotherapy.
• • Part 2 Expansion Cohort 4: in the solid tumor cohort, pathologically diagnosed metastatic or locally advanced solid tumor with clearly inactivating NF2 mutations/alterations or YAP/TAZ gene rearrangements, which have progressed on or after approved therapies of known clinical benefit except if the patient refuses or is not a candidate for such therapy.
• • Part 2 Expansion Cohort 5: pathologically diagnosed advanced malignant pleural mesothelioma with epithelioid histology, that has progressed on or after licensed immunotherapy, chemotherapy or combined chemoimmunotherapy except if the patient refuses or is not a candidate for such therapy.
• • Part 3 Combination Cohort A: pathologically diagnosed, metastatic or unresectable malignant mesothelioma including both pleural and non-pleural) patients who have not received systemic therapy.
• • Part 3 Combination Cohort B: 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 1: evaluable or measurable disease per RECIST v1.1 or mRECIST
• • Part 2 and 3: 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
• • Corrected QT (QTcF) interval \> 470 msec (using Fridericia's correction formula); except for Part 2 Expansion Cohort 3, the QTcF interval criteria is \> 450 msec)
• • Additional active malignancy that may confound the assessment of the study endpoints
• • Women who are pregnant or breastfeeding
• • Prior treatment with TEAD inhibitor, except for EHE patients