NCT04665206 Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors
| NCT ID | NCT04665206 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Vivace Therapeutics, Inc |
| Condition | Solid Tumor, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 434 participants |
| Start Date | 2021-03-24 |
| Primary Completion | 2029-11-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 434 participants in total. It began in 2021-03-24 with a primary completion date of 2029-11-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 patients with mesothelioma and/or metastatic solid tumors that are resistant to standard therapy or for which no effective standard therapy is available.
Eligibility Criteria
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.
Contact & Investigator
Neelesh Sharma, MD
STUDY DIRECTOR
Vivace Therapeutics
Frequently Asked Questions
Who can join the NCT04665206 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumor, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04665206 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04665206 currently recruiting?
Yes, NCT04665206 is actively recruiting participants. Contact the research team at hfritz@inclin.com for enrollment information.
Where is the NCT04665206 trial being conducted?
This trial is being conducted at San Francisco, United States, Chicago, United States, Boston, United States, Boston, United States and 8 additional locations.
Who is sponsoring the NCT04665206 clinical trial?
NCT04665206 is sponsored by Vivace Therapeutics, Inc. The principal investigator is Neelesh Sharma, MD at Vivace Therapeutics. The trial plans to enroll 434 participants.