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FOG-001 in Locally Advanced or Metastatic Solid Tumors

NCT05919264 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 595

Last updated 2026-05-12

No results posted yet for this study

Summary

The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic solid tumors.

Conditions

Interventions

DRUG

mFOLFOX-6

mFOLFOX-6 will be administered per the prescribing information in combination with FOG-001

DRUG

Nivolumab

Nivolumab will be administered per the prescribing information in combination with FOG-001

DRUG

Trifluridine/tipiracil

Trifluridine/tipiracil will be administered per the prescribing information in combination with FOG-001

DRUG

Bevacizumab

Bevacizumab will be administered per the prescribing information in combination with FOG-001

DRUG

FOG-001

FOG-001 will be administered subcutaneous at assigned doses in continuous cycles of 28 days

DRUG

FOG-001

FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days

Sponsors & Collaborators

  • Parabilis Medicines, Inc.

    lead INDUSTRY

Principal Investigators

  • Jorge Ramos, DO · Parabilis Medicines, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-23
Primary Completion
2027-04-01
Completion
2027-08-31
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05919264 on ClinicalTrials.gov