FOG-001 in Locally Advanced or Metastatic Solid Tumors

Agents: FOG-001
Phase I/II
Status Recruiting
Sponsor Parabilis Medicines, Inc.

 

For further information please also consult https://clinicaltrials.gov/study/NCT05919264

This phase 1/2 (first in human), open-label, non-randomized, dose escalation and dose expansion study evaluates the safety, tolerability, PK, pharmacodynamics, and antitumor activity of FOG-001 in patients with advanced or metastatic solid tumors likely or known to have a Wnt pathway activating mutation (WPAM). It includes patients with desmoid tumors (aggressive fibromatosis).

For desmoid patients, FOG-001 (a novel, targeted drug) is tested as monotherapy. For further indications it is also tested in combination with other anticancer agents.

WHO is the trial for?
    • Overall health should be good (ECOG 0-1)
    • Diagnosis of any treatment-refractory advanced/metastatic solid tumor solid tumor with documented WNT-pathway activating mutations (WPAMs)
      • e. g. colorectal cancer, hepatocellular carcinoma (HCC)
      • Desmoid tumor (aggressive fibromatosis)

     

    Excluded is history of bone metastasis, osteoporosis, inflammatory bowel disease.

WHAT is the key question that this trial is attempting to answer?

 Is FOG‑001 safe and effective in treating people with locally advanced, e.g. desmoid tumors, or metastatic solid tumors?

WHY patients might want to participate?

 This clinical trial offers patients an opportunity to access a new therapy strategy.

This trial will further support the research in desmoid tumors/aggressive fibromatosis and potentially help other patients with this disease.

The trial might or might not have benefit in your individual case.

More about the importance and benefits of joining clinical trials: Please click here.

WHEN will the trial be open?

 This study is open for recruitment.

WHERE is the trial available?

 The trial is being conducted in the US. For further information check here.

STUDY DESIGN: What does the study look like?

 The trial consists of three sequential parts.

  1. Dose Escalation
  2. Dose Expansion
  3. Combination

Its goals: evaluate safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD), and preliminary anti‑tumor activity of FOG‑001—alone (for desmoid patients) and in combination with other therapies.

HOW do I get more information?

 Patient organisations supporting desmoid (or sarcoma) patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving sarcoma patients. If there are no such organisation in your country, please email us for more information: info@sarcoma-patients.org

 

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

Merken