The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic cancer.
This is a FIH, Phase 1/2, multicenter, open-label, non-randomized, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, pharmacodynamics, and antitumor activity of FOG-001 as monotherapy and in combination with other anticancer agents in participants with advanced or metastatic solid tumors likely or known to have a Wnt pathway activating mutation (WPAM).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
575
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
mFOLFOX-6 will be administered per the prescribing information in combination with FOG-001
Nivolumab will be administered per the prescribing information in combination with FOG-001
Trifluridine/tipiracil will be administered per the prescribing information in combination with FOG-001
Bevacizumab will be administered per the prescribing information in combination with FOG-001
Honor Health
Scottsdale, Arizona, United States
RECRUITINGArizona Cancer Center at University of Arizona
Tucson, Arizona, United States
RECRUITINGStanford Cancer Institute, Stanford University
Palo Alto, California, United States
RECRUITINGUniversity of California San Francisco, Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
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
Time frame: Through study completion, an average of 10 months
During dose escalation characterize dose-limiting toxicities (DLTs)
Incidence of DLTs
Time frame: 1 treatment cycle (28 days)
During dose expansion describe the Overall Response Rate using RECIST v1.1
The rate of objective responses (Partial \& Complete) using RECIST v1.1
Time frame: Every 63 days until study completion, approximately 10 months on average
During dose expansion describe the Disease Control Rate using RECIST v1.1 (Part 2a only)
The rate of objective responses (Stable, Partial, \& Complete) using RECIST v1.1
Time frame: 4 months
During dose expansion describe the PSA30 response rate for participants with prostate cancer
The response to treatment as a 30% or greater reduction in PSA levels from baseline
Time frame: Baseline, weekly during the first 2 cycles (56 days), bi-weekly during the Cycle 3 (28 days), and then monthly (up to approximately 7 months)
Maximum observed plasma concentration (Cmax) of FOG-001 and associated metabolites
Time frame: During first 2 cycles (56 days)
Time to achieve Cmax (Tmax) of FOG-001 and associated metabolites in plasma
Time frame: During first 2 cycles (56 days)
Area under the plasma concentration-time curve (AUC) of FOG-001 and associated metabolites
Time frame: During first 2 cycles (56 days)
Plasma trough concentration (Ctrough) of FOG-001 and associated metabolites
Time frame: During first 2 cycles (56 days)
Clearance (CL) of FOG-001 from the plasma
Time frame: During first 2 cycles (56 days)
Volume of distribution of FOG-001
Time frame: During first 2 cycles (56 days)
During dose escalation select the preliminary recommended Phase 2 dose and dosing schedule of study drug
Time frame: Through Part 1 study completion
Rate of DLTs across dose levels
Time frame: During Cycle 1 (28 days)
During dose escalation Part 1b to evaluate the pharmacodynamic activity in tumors
Change in tumor Myc expression (on-study compared to baseline)
Time frame: During first 2 cycles (56 days)
During dose escalation and expansion to describe Best Overall Response Rate using RECIST v1.1
Best response to treatment using RECIST v1.1
Time frame: Every 63 days until study completion, approximately 10 months on average
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
Time frame: Every 63 days until study completion, approximately 10 months on average
During dose escalation and expansion describe Progression Free Survival
Progression Free Survival (PFS) using RECIST v1.1
Time frame: From date of randomization until the date of first disease progression, an average of 10 months
During dose escalation and expansion describe the Disease Control Rate using RECIST v1.1
The rate of objective responses (Stable, Partial, \& Complete) using RECIST v1.1
Time frame: Every 63 days until study completion, approximately 10 months on average
During dose escalation and expansion describe the Time To Progression using RECIST v1.1
Time To Progression (TTP) using RECIST v1.1
Time frame: From date of randomization until the date of first disease progression, an average of 10 months
During dose escalation and expansion describe radiographic Progression Free Survival for participants with prostate cancer
Radiographic Progression Free Survival (rPFS) using PCWG3 assessment criteria
Time frame: From date of randomization until the date of first disease progression, an average of 10 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sarcoma Oncology Center
Santa Monica, California, United States
RECRUITINGYale University School of Medicine
New Haven, Connecticut, United States
RECRUITINGJohns Hopkins University, Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
RECRUITINGFlorida Cancer Specialists
Lake Mary, Florida, United States
RECRUITINGJohns Hopkins University, The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITING...and 13 more locations