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RecruitingLast updated: 5 February 2024

Vivace: This Phase I trial is trying to understand how safe and tolerable a targeted therapy drug (VT3989) is in people with advanced pleural malignant mesothelioma or other metastatic solid tumoursPhase 1, Multi-Center, Open-Label, Study to Evaluate the Safety, Tolerability, and PK of VT3989 in Patients With Refractory Locally Advanced or Metastatic Solid Tumors Enriched for Tumors Harboring Mutations of the NF2 Gene

Clinical summary

Summary

This is a sequential assignment trial with two phases. Phase 1 focuses on Dose Escalation. During dose escalation, participants will receive VT3989 dosed orally once per day in 21 day cycles, at escalating dose levels, until the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is determined. Phase 2 focuses on Dose Expansion. During Dose Expansion, participants will be divided into 2 cohorts: Cohort 1 - malignant pleural mesothelioma patients with mutations of NF2 that have progressed on or following standard therapy; and Cohort 2 - solid tumour patients with mutations of NF2 that have progressed on or following standard therapy. Participants will be treated at the MTD or RP2D identified in Part 1, to provide further characterization of the safety, tolerability, efficacy, and biological activity of VT3989. **Update 09/01/2023: PCCTU is currently only recruiting for the mesothelioma cohort**.

Conditions

This trial is treating patients with mesothelioma or metastatic solid tumours

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

Trial Acronym

Vivace

More information

Trial Identifiers

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Trial sponsor

Vivace Therapeutics, Inc

Scientific Title

Phase 1, Multi-Center, Open-Label, Study to Evaluate the Safety, Tolerability, and PK of VT3989 in Patients With Refractory Locally Advanced or Metastatic Solid Tumors Enriched for Tumors Harboring Mutations of the NF2 Gene

Eligibility

Inclusion

  • 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: 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. In the solid tumor cohort, pathologically diagnosed solid tumor with documented NF2 mutations.
  • Measurable disease per RECIST v1.1 for non-pleural mesothelioma or other solid tumors (solid tumor expansion cohort) or modified RECIST v1.1 for malignant pleural mesothelioma.
  • ECOG: 0-1

Exclusion

  • Active brain metastases
  • History of leptomeningeal metastases
  • Active or chronic, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
  • HIV positive or active Hepatitis B or Hepatitis C
  • Clinically significant cardiovascular disease
  • Additional active malignancy that may confound the assessment of the study endpoints
  • Women who are pregnant or breastfeeding

Inclusion

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

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