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FOG-001 in Locally Advanced or Metastatic Solid Tumors

Primary Purpose

Cancer, Colorectal Cancer, Solid Tumor

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
FOG-001
FOG-001
Sponsored by
Fog Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring 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)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. Osteoporosis, which is defined as a T-score of <-2.0 at the lumbar spine (L1 - L4), left (or right) femoral neck, and left (or right) total hip as determined by DXA scan. 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.

Sites / Locations

  • Massachusetts General HospitalRecruiting
  • South Texas Accelerated Research Therapeutics, LLCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Part 1a

Part 1b

Cohort 2a

Cohort 2b

Cohort 2c

Cohort 2d

Arm Description

Solid Tumors with Any WNT-Pathway Activating Mutations (WPAMs) or Microsatellite Stable (MSS) Colorectal Cancer (Irrespective of WPAM Status)

Microsatellite Stable Colorectal Cancer (Irrespective of WPAM Status)

Microsatellite Stable Colorectal Cancer (Irrespective of WPAM Status)

Non-Small Cell Lung Cancer with a WNT-Pathway Activating Mutation (WPAM) in Adenomatous Polyposis Coli (APC) or Beta-Catenin

Gastric Cancer/Gastroesophageal Junction Carcinoma (GEJ) with a WNT-Pathway Activating Mutation (WPAM) in Adenomatous Polyposis Coli (APC) or Beta-Catenin

Solid Tumors with Any WNT-Pathway Activating Mutations (WPAMs)

Outcomes

Primary Outcome Measures

During dose escalation and dose expansion measure incidence and severity of treatment emergent adverse events by CTCAE v5.0
Number and severity of treatment emergent adverse events as assessed by CTCAE v5.0
During dose escalation characterize dose-limiting toxicities (DLTs)
Incidence of DLTs
During dose expansion describe the Overall Response Rate using RECIST v1.1
The rate of objective responses (Partial & Complete) using RECIST v1.1

Secondary Outcome Measures

Plasma concentration (Cmax) of FOG-001
Time to achieve Cmax (Tmax) of FOG-001 in plasma
Area under the plasma concentration-time curve (AUC) of FOG-001
Clearance (CL) of FOG-001 from the plasma
Terminal half-life (t1/2) of FOG-001 in plasma
During dose escalation select the recommended Phase 2 dose and dosing schedule of study drug
Rate of Dose Limiting Toxicities (DLTs) across dose levels
During dose escalation Part 1b to evaluate the pharmacodynamic activity in tumors
Change in tumor Myc expression (on-study compared to baseline)
During dose escalation and expansion to describe Best Overall Response Rate using RECIST v1.1
Best response to treatment using RECIST v1.1
During dose escalation and expansion to describe Duration of Response using RECIST v1.1
Time from initial objective response (partial response or complete response) to disease progression
During dose expansion describe Progression Free Survival
Progression Free Survival (PFS) using RECIST v1.1

Full Information

First Posted
May 19, 2023
Last Updated
September 25, 2023
Sponsor
Fog Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05919264
Brief Title
FOG-001 in Locally Advanced or Metastatic Solid Tumors
Official Title
A Phase 1/2 Study of FOG-001 in Participants With Locally Advanced or Metastatic Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2023 (Actual)
Primary Completion Date
April 1, 2027 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fog Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
208 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1a
Arm Type
Experimental
Arm Description
Solid Tumors with Any WNT-Pathway Activating Mutations (WPAMs) or Microsatellite Stable (MSS) Colorectal Cancer (Irrespective of WPAM Status)
Arm Title
Part 1b
Arm Type
Experimental
Arm Description
Microsatellite Stable Colorectal Cancer (Irrespective of WPAM Status)
Arm Title
Cohort 2a
Arm Type
Experimental
Arm Description
Microsatellite Stable Colorectal Cancer (Irrespective of WPAM Status)
Arm Title
Cohort 2b
Arm Type
Experimental
Arm Description
Non-Small Cell Lung Cancer with a WNT-Pathway Activating Mutation (WPAM) in Adenomatous Polyposis Coli (APC) or Beta-Catenin
Arm Title
Cohort 2c
Arm Type
Experimental
Arm Description
Gastric Cancer/Gastroesophageal Junction Carcinoma (GEJ) with a WNT-Pathway Activating Mutation (WPAM) in Adenomatous Polyposis Coli (APC) or Beta-Catenin
Arm Title
Cohort 2d
Arm Type
Experimental
Arm Description
Solid Tumors with Any WNT-Pathway Activating Mutations (WPAMs)
Intervention Type
Drug
Intervention Name(s)
FOG-001
Intervention Description
FOG-001 will be administered IV once weekly at assigned doses in continuous cycles of 28 days
Intervention Type
Drug
Intervention Name(s)
FOG-001
Intervention Description
FOG-001 will be administered IV once weekly at the RP2D dose in continuous cycles of 28 days
Primary Outcome Measure Information:
Title
During dose escalation and dose expansion measure incidence and severity of treatment emergent adverse events by CTCAE v5.0
Description
Number and severity of treatment emergent adverse events as assessed by CTCAE v5.0
Time Frame
Through study completion, an average of 4 months
Title
During dose escalation characterize dose-limiting toxicities (DLTs)
Description
Incidence of DLTs
Time Frame
1 treatment cycle (28 days)
Title
During dose expansion describe the Overall Response Rate using RECIST v1.1
Description
The rate of objective responses (Partial & Complete) using RECIST v1.1
Time Frame
Every 56 days until study completion, approximately 4 months on average
Secondary Outcome Measure Information:
Title
Plasma concentration (Cmax) of FOG-001
Time Frame
During first 2 cycle (56 days)
Title
Time to achieve Cmax (Tmax) of FOG-001 in plasma
Time Frame
During first 2 cycle (56 days)
Title
Area under the plasma concentration-time curve (AUC) of FOG-001
Time Frame
During first 2 cycle (56 days)
Title
Clearance (CL) of FOG-001 from the plasma
Time Frame
During first 2 cycle (56 days)
Title
Terminal half-life (t1/2) of FOG-001 in plasma
Time Frame
During first 2 cycle (56 days)
Title
During dose escalation select the recommended Phase 2 dose and dosing schedule of study drug
Description
Rate of Dose Limiting Toxicities (DLTs) across dose levels
Time Frame
During Cycle 1 (28 days)
Title
During dose escalation Part 1b to evaluate the pharmacodynamic activity in tumors
Description
Change in tumor Myc expression (on-study compared to baseline)
Time Frame
During first 2 cycles (56 days)
Title
During dose escalation and expansion to describe Best Overall Response Rate using RECIST v1.1
Description
Best response to treatment using RECIST v1.1
Time Frame
Every 56 days until study completion, approximately 4 months on average
Title
During dose escalation and expansion to describe Duration of Response using RECIST v1.1
Description
Time from initial objective response (partial response or complete response) to disease progression
Time Frame
Every 56 days until study completion, approximately 4 months on average
Title
During dose expansion describe Progression Free Survival
Description
Progression Free Survival (PFS) using RECIST v1.1
Time Frame
From date of randomization until the date of first disease progression, an average of 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. Osteoporosis, which is defined as a T-score of <-2.0 at the lumbar spine (L1 - L4), left (or right) femoral neck, and left (or right) total hip as determined by DXA scan. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trial Inquiries
Phone
(857) 259-6305
Email
clinicaltrials@fogpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith Orford, MD, PhD
Organizational Affiliation
Fog Pharmaceuticals, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samuel Klempner, MD
Phone
617-724-4000
Facility Name
South Texas Accelerated Research Therapeutics, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyriakos Papadopoulos, MD
Phone
210-593-5700

12. IPD Sharing Statement

Plan to Share IPD
No

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FOG-001 in Locally Advanced or Metastatic Solid Tumors

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