A Phase 1/2 interventional study of FOG-001 and mFOLFOX-6 in Cancer, Colorectal Cancer and Solid Tumor, sponsored by Parabilis Medicines, Inc.. Recruiting at 33 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Parabilis Medicines, Inc. · Phase 1/2, Interventional, and Treatment
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 or in participants with familial adenomatous polyposis (FAP).
This is a FIH, Phase 1/2, multicenter, open-label, non-randomized, dose escalation, dose expansion, and multiple subcutaneous dose 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), and FAP, a disorder of this pathway characterized by a germline mutation in the APC gene.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 619 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →This is the only study on the registry with Parabilis Medicines, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Additional Inclusion Criteria for Dose Escalation Cohorts (Part 1a and Part 1g):
Additional Inclusion Criteria for Dose Escalation Cohorts (Part 1b):
Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1c and Part 2c):
Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1d, Part 1h, and Part 2d):
Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-1 and Part 2f-1) FOG-001 + FOLFOX + Bevacizumab:
Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-2 and Part 2f-2): FOG-001 + Nivolumab
Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-3 and Part 2f-3): FOG-001 + Trifluridine/Tipiracil + Bevacizumab
Monotherapy Dose Optimization (Part 1i): FAP
Additional Inclusion Criteria for Dose Expansion Cohort (Part 2a):
Additional Inclusion Criteria for Dose Expansion Cohort (Part 2b):
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Solid Tumors with any WNT-Pathway Activating Mutation (WPAM) or Microsatellite Stable (MSS) Colorectal Cancer (CRC), irrespective of WPAM status
Drug: FOG-001
MSS CRC (known WPAM negative participants are not eligible)
Drug: FOG-001
Hepatocellular Carcinoma (documented WPAM in APC or CTNNB1 required)
Drug: FOG-001
Desmoid Tumors
Drug: FOG-001
Desmoid Tumors
Drug: FOG-001
MSS CRC (known WPAM negative participants are not eligible)
Drug: FOG-001 · Drug: mFOLFOX-6 · Drug: Bevacizumab
Solid Tumors with documented WPAM or MSS CRC (known WPAM negative participants are not eligible)
Drug: FOG-001 · Drug: Nivolumab
MSS CRC (known WPAM negative participants are not eligible)
Drug: FOG-001 · Drug: Trifluridine/tipiracil · Drug: Bevacizumab
Solid Tumors with documented WPAM (known WPAM negative participants are not eligible)
Drug: FOG-001
Desmoid Tumors
Drug: FOG-001
Familial adenomatous polyposis (FAP)
Drug: FOG-001
MSS CRC, irrespective of WPAM status
Drug: FOG-001
Solid Tumors with documented WPAM
Drug: FOG-001
Hepatocellular Carcinoma (documented WPAM in APC or CTNNB1 required)
Drug: FOG-001
Desmoid Tumors
Drug: FOG-001
Metastatic Castration-Resistant Prostate Cancer (documented WPAM in APC or CTNNB1 required)
Drug: FOG-001
MSS CRC (known WPAM negative participants are not eligible)
Drug: FOG-001 · Drug: mFOLFOX-6 · Drug: Bevacizumab
Solid Tumors with documented WPAM or MSS CRC (known WPAM negative participants are not eligible)
Drug: FOG-001 · Drug: Nivolumab
MSS CRC (known WPAM negative participants are not eligible)
Drug: FOG-001 · Drug: Trifluridine/tipiracil · Drug: Bevacizumab
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
Also known as: Leucovorin, 5-fluorouracil, Oxaliplatin
Nivolumab will be administered per the prescribing information in combination with FOG-001
Also known as: Opdivo
Trifluridine/tipiracil will be administered per the prescribing information in combination with FOG-001
Also known as: Lonsurf
Bevacizumab will be administered per the prescribing information in combination with FOG-001
Also known as: Avastin
FOG-001 will be administered subcutaneous at assigned doses in continuous cycles of 28 days
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
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Plan to share: No
Started May 2023 (actual). Primary completion is estimated for Apr 2027, 46 months after the start.
Of 194 industry-sponsored phase 1/2 interventional studies under Neoplasms, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 88. This study's planned 46 months is below that.
Counting every sponsor, half of 296 studies reached it within 60 months; a quarter within 39 and three quarters within 89.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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