Trial Title:
FOG-001 in Locally Advanced or Metastatic Solid Tumors
NCT ID:
NCT05919264
Condition:
Cancer
Colorectal Cancer
Solid Tumor
Locally Advanced Solid Tumor
Metastatic Cancer
Gastric Cancer
Non-small Cell Lung Cancer
Non-small Cell Carcinoma
Non-small Cell Lung Cancer Metastatic
Non-small Cell Lung Cancer Stage IIIB
Non-Small Cell Carcinoma of Lung, TNM Stage 4
Gastroesophageal-junction Cancer
WNT Pathway
β-catenin
Beta-catenin
Adenomatous Polyposis Coli
APC
Conditions: Official terms:
Carcinoma
Neoplasms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Stomach Neoplasms
Neoplasm Metastasis
Adenomatous Polyposis Coli
Conditions: Keywords:
Cancer
Colorectal Cancer
Solid Tumor
Locally Advanced Solid Tumor
Metastatic Cancer
WNT Pathway Activating Mutation (WPAM)
Non-small Cell Lung Cancer (NSCLC)
Gastric Cancer (GC)
Gastroesophageal-junction Cancer (GEJ)
Colorectal Cancer (CRC)
Microsatellite Stable (MSS)
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
FOG-001
Description:
FOG-001 will be administered IV at assigned doses in continuous cycles of 21 or 28 days
Arm group label:
Part 1a
Arm group label:
Part 1b
Intervention type:
Drug
Intervention name:
FOG-001
Description:
FOG-001 will be administered IV once weekly at the preliminary RP2D dose in continuous
cycles of 21 or 28 days
Arm group label:
Cohort 2a
Arm group label:
Cohort 2b
Arm group label:
Cohort 2c
Arm group label:
Cohort 2d
Summary:
The goal of this clinical trial is to determine if FOG-001 is safe and effective in
participants with locally advanced or metastatic cancer.
Detailed description:
This first-in-human, Phase 1/2, multicenter, open-label, non-randomized dose escalation
and expansion study will evaluate the safety, tolerability, pharmacokinetics (PK),
pharmacodynamics (PD), and antitumor activity of FOG-001 in participants with locally
advanced or metastatic solid tumors. FOG-001 is a first-in-class direct inhibitor of
Beta-catenin, which functions by blocking its interaction with the T-cell factor (TCF)
family of transcription factors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ and marrow function.
Additional Inclusion Criteria for Dose Escalation Cohorts (Part 1a):
- Diagnosis of treatment-refractory advanced/metastatic solid tumor that is non-MSI-H
or non-dMMR colorectal cancer (CRC) or any other solid tumor with documented WNT-
pathway activating mutations (WPAMs).
Additional Inclusion Criteria for Dose Escalation Cohorts (Part 1b):
- Diagnosis of treatment-refractory advanced/metastatic non-MSI-H or non-dMMR CRC.
- At least one lesion that is suitable for a core needle biopsy.
Additional Inclusion Criteria for Dose Expansion Cohort (Cohort 2a): Colorectal Cancer
(CRC) Cohort
- Diagnosis of treatment-refractory advanced/metastatic non-MSI-H or non-dMMR CRC.
Additional Inclusion Criteria for Dose Expansion Cohort (Cohort 2b): Non-small Cell Lung
Cancer (NSCLC) Cohort
- Diagnosis of treatment-refractory advanced/metastatic NSCLC with documented WPAMs in
adenomatous polyposis coli (APC) or Beta-catenin.
Additional Inclusion Criteria for Dose Expansion Cohort (Cohort 2c):
Gastric/Gastroesophageal junction (GEJ) Cohort
- Diagnosis of treatment-refractory advanced/metastatic gastric/GEJ cancer with
documented WPAMs in APC or Beta-catenin.
Additional Inclusion Criteria for Dose Expansion Cohort (Cohort 2d): Tumor Agnostic
Cohort
- Diagnosis of treatment-refractory advanced/metastatic solid tumor with documented
WPAMs.
Exclusion Criteria:
- Known history of bone metastasis.
- Evidence of vertebral compression fracture or non-traumatic bone fracture within the
past 12 months and who are not receiving antiresorptive therapy.
- Osteoporosis, which is defined as a T-score of <-2.5 at the lumbar spine (L1 - L4),
left (or right) femoral neck or left (or right) total hip as determined by DXA scan,
or a FRAX 10-year probability of hip fracture ≥3% or a 10-year probability of major
osteoporosis-related fracture ≥20%, based on the US-adapted WHO algorithm for
postmenopausal women and men ≥50 years of age.
- Inflammatory bowel disease (i.e., ulcerative colitis or Crohn's disease) that is
recently active or requires therapy currently.
- Unstable/inadequate cardiac function.
- Has known meningeal carcinomatosis, leptomeningeal carcinomatosis, spinal cord
compression, or symptomatic or unstable brain metastases.
- Pregnant, lactating, or planning to become pregnant.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Honor Health
Address:
City:
Scottsdale
Zip:
85258
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sunil Sharma, MD
Phone:
480-323-1350
Facility:
Name:
Yale University School of Medicine
Address:
City:
New Haven
Zip:
06520
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michael Cecchini, MD
Phone:
415-302-7807
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Samuel Klempner, MD
Phone:
617-724-4000
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Moh'd Khushman, MD
Phone:
314-362-9115
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rona Yaeger, MD
Phone:
646-888-5109
Facility:
Name:
Oregon Health and Science University
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shivaani Kummar, MD
Phone:
503-494-8534
Facility:
Name:
Sarah Cannon Research Institute
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Meredith S Pelster, MD
Phone:
615-329-6862
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jordi Rodon Ahnert, MD/PhD
Phone:
713-792-5603
Facility:
Name:
South Texas Accelerated Research Therapeutics, LLC
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kyriakos Papadopoulos, MD
Phone:
210-593-5255
Start date:
May 23, 2023
Completion date:
August 31, 2027
Lead sponsor:
Agency:
Fog Pharmaceuticals, Inc.
Agency class:
Industry
Source:
Fog Pharmaceuticals, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05919264
