Conditions

Solid Tumors

Purpose of the study

This is a two-part Phase 1, open label, multi-center, single arm, non-randomized, multiple dose, safety, pharmacokinetic (PK) and preliminary efficacy study of single agent NST-628 in adult patients with MAPK pathway mutated/dependent advanced solid tumors who have exhausted standard treatment options. NCT06326411 

Official Title

A Phase 1, open label single-arm two-part study to investigate safety, pharmacokinetics, and preliminary efficacy of pan-RAF/MEK glue NST-628 oral tablets in subjects with solid tumors harboring genetic alterations in the MAPK pathway and with other solid tumors.

Who is eligible to participate?

• Subjects must be ≥18 years old (or of legal age of consent in the country in which the study is taking place) at the time of signing the informed consent.
• Subjects who have a histologically or cytologically documented metastatic or locally advanced solid tumor, for which standard of care (SoC) therapy does not exist, no longer provides benefit, or is not tolerated by the subject, or the subject has been assessed by the Investigator as not being suitable for SoC therapy.
  • Part A: Subjects with any solid tumor with genetic alteration of or evidence of tumor dependence upon the RAS/MAPK pathway (subject to additional restrictions specified in the study protocol)
  • Part B: Subjects must be diagnosed with one of the following solid tumors harboring specified genetic alterations based on a validated local test:
    • i. Melanoma Cohorts:
      1. Activating NRAS mutations
      2. Select BRAF alterations
    • ii. Non-Melanoma Cohorts:
      1. Solid tumors with NRAS activating mutations
      2. Solid tumors with KRAS activating mutations
      3. Solid tumors with select BRAF alterations
      4. Glioma with BRAF alterations
• Newly obtained or archived tumor tissue is required
• Part B: measurable disease as defined by RECIST Version 1.1 or by other disease assessment tool standard for a given tumor type (if RECIST v. 1.1 is not standard)
• Performance status
  • Solid tumors other than glioma: ECOG 0 or 1
  • Glioma: Karnofsky ≥ 70 and ECOG 0 or 1
• Have adequate organ function
• Understand and voluntarily sign an Institutional Review Board/Independent Ethics Committee-approved informed consent form prior to any study-specific evaluation.
• Life expectancy ≥ 12 weeks

Register your interest

To register your interest or find out more information about this clinical trial, please email: enquiries@gallipoliresearch.org.au. 

Study location

Gallipoli Medical Research, Greenslopes Private Hospital, Brisbane