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NCT04665206 | RECRUITING | Solid Tumor, Adult

Study to Evaluate VT3989 in Patients with Metastatic Solid Tumors
Sponsor:

Vivace Therapeutics, Inc

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 3- or 4-week cycles in patients with mesothelioma and/or metastatic solid tumors that are resistant or refractory to standard therapy or for which no effective standard therapy is available.

Condition or disease

Solid Tumor, Adult

Mesothelioma

NSCLC

Intervention/treatment

VT3989

Nivolumab & Ipilimumab

Osimertinib

Phase

PHASE1

Detailed Description:

Dose escalation (Part 1) will employ a traditional 3 + 3 design to assess safety of VT3989 in patients with refractory metastatic solid tumors or mesothelioma. The 3 + 3 design will be implemented until the MTD or recommended phase 2 dose(s) and schedule(s) are determined. The MTD is defined as the highest dose level at which \< 33% of patients experience a dose limiting toxicity (DLT) during the first cycle of the study (Cycle 1). Dose Expansion (Part 2) will further evaluate the safety and assess preliminary antitumor activity at the recommended phase 2 dose(s) and schedule(s) with up to 6 cohorts. Expansion cohorts 1 and 2 will enroll patients with mesothelioma of any site origin with or without NF2 mutations. Expansion cohort 3 will enroll non-pleural mesothelioma patients. Expansion cohort 4 will enroll solid tumor patients with clearly inactivating NF2 mutations/alterations or YAP/TAZ gene rearrangements. Cohort 5 will enroll pleural mesothelioma patients. Combination part (Part 3) includes two cohorts. Cohort A will enroll mesothelioma patients who will receive VT3989 in combination with immunotherapy (nivolumab plus ipilimumab). Cohort B will enroll NSCLC patients whose tumors have exon 19 deletion or exon 21 L858R mutation and will receive VT3989 in combination with targeted therapy (Osimertinib).

Study Type : INTERVENTIONAL
Estimated Enrollment : 336 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Phase 1, Multi-Center, Open-Label Study of VT3989, Alone or in Combination, in Patients with Refractory Locally Advanced or Metastatic Solid Tumors
Actual Study Start Date : 2021-03-24
Estimated Primary Completion Date : 2026-12-24
Estimated Study Completion Date : 2027-06-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Study to Evaluate VT3989 in Patients with Metastatic Solid Tumors

Location Details

NCT04665206

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Illinois

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

RECRUITING

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

RECRUITING

United States, Massachusetts

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

RECRUITING

United States, Minnesota

M Health Fairview University of Minnesota Medical Center

Minneapolis, Minnesota, United States, 55455

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center-

New York, New York, United States, 10065

RECRUITING

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

United States, Texas

NEXT Oncology

San Antonio, Texas, United States, 78229

RECRUITING

Australia, Victoria

Monash Health

Clayton, Victoria, Australia, 3168

RECRUITING

Australia, Victoria

Peter MacCullum Cancer Centre

Melbourne, Victoria, Australia, 3000

RECRUITING

Australia, Western Australia

Linear Clinical Research

Nedlands, Western Australia, Australia, 6009