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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 and Part 1g): - 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 Escalation and Dose Expansion Cohorts (Part 1c and Part 2c): - Histologically, cytologically, or radiographically confirmed HCC with a documented WPAM (by local ctDNA or tumor NGS testing) in APC or CTNNB1 Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1d, Part 1h, and Part 2d): - Desmoid tumor (aggressive fibromatosis) Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-1 and Part 2f-1) FOG-001 + FOLFOX + Bevacizumab: - Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR CRC - Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible. - One dose of mFOLFOX6 with or without bevacizumab in the unresectable or metastatic setting prior to enrollment is allowed. Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-2 and Part 2f-2): FOG-001 + Nivolumab - Non-MSI-H or non-dMMR (by local testing) CRC with or without liver metastases. - MSI-H CRC or solid tumors that are WPAM and resistant to a-PD-1/PD-L1 - Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-3 and Part 2f-3): FOG-001 + Trifluridine/Tipiracil + Bevacizumab - Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR (by local testing) CRC - Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible. Additional Inclusion Criteria for Dose Expansion Cohort (Part 2a): - Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR (by local testing) CRC Additional Inclusion Criteria for Dose Expansion Cohort (Part 2b): - Diagnosis of advanced or metastatic solid tumors with a documented WPAM (by local testing) or equivalent evidence

Exclusion Criteria

  • Known history of bone metastasis. Bone metastasis are allowed for patients with mCRPC. - 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. - Uncontrolled inflammatory bowel disease (i.e., ulcerative colitis or Crohn's disease) - 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.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1a 		Solid Tumors with any WNT-Pathway Activating Mutation (WPAM) or Microsatellite Stable (MSS) Colorectal Cancer (CRC), irrespective of WPAM status
  • Drug: FOG-001
    FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Experimental
Part 1b 		MSS CRC (known WPAM negative participants are not eligible)
  • Drug: FOG-001
    FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Experimental
Part 1c 		Hepatocellular Carcinoma (documented WPAM in APC or CTNNB1 required)
  • Drug: FOG-001
    FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Experimental
Part 1d-1 		Desmoid Tumors
  • Drug: FOG-001
    FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Experimental
Part 1d-2 		Desmoid Tumors
  • Drug: FOG-001
    FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Experimental
Part 1f-1 		MSS CRC (known WPAM negative participants are not eligible)
  • Drug: FOG-001
    FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
  • Drug: mFOLFOX-6
    mFOLFOX-6 will be administered per the prescribing information in combination with FOG-001
    Other names:
    • Leucovorin, 5-fluorouracil, Oxaliplatin
  • Drug: Bevacizumab
    Bevacizumab will be administered per the prescribing information in combination with FOG-001
    Other names:
    • Avastin
Experimental
Part 1f-2 		Solid Tumors with documented WPAM or MSS CRC (known WPAM negative participants are not eligible)
  • Drug: FOG-001
    FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
  • Drug: Nivolumab
    Nivolumab will be administered per the prescribing information in combination with FOG-001
    Other names:
    • Opdivo
Experimental
Part 1f-3 		MSS CRC (known WPAM negative participants are not eligible)
  • Drug: FOG-001
    FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
  • Drug: Trifluridine/tipiracil
    Trifluridine/tipiracil will be administered per the prescribing information in combination with FOG-001
    Other names:
    • Lonsurf
  • Drug: Bevacizumab
    Bevacizumab will be administered per the prescribing information in combination with FOG-001
    Other names:
    • Avastin
Experimental
Part 1g 		Solid Tumors with documented WPAM (known WPAM negative participants are not eligible)
  • Drug: FOG-001
    FOG-001 will be administered subcutaneous at assigned doses in continuous cycles of 28 days
Experimental
Part 1h 		Desmoid Tumors
  • Drug: FOG-001
    FOG-001 will be administered subcutaneous at assigned doses in continuous cycles of 28 days
Experimental
Part 2a 		MSS CRC, irrespective of WPAM status
  • Drug: FOG-001
    FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Experimental
Part 2b 		Solid Tumors with documented WPAM
  • Drug: FOG-001
    FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Experimental
Part 2c 		Hepatocellular Carcinoma (documented WPAM in APC or CTNNB1 required)
  • Drug: FOG-001
    FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Experimental
Part 2d 		Desmoid Tumors
  • Drug: FOG-001
    FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Experimental
Part 2e 		Metastatic Castration-Resistant Prostate Cancer (documented WPAM in APC or CTNNB1 required)
  • Drug: FOG-001
    FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Experimental
Part 2f-1 		MSS CRC (known WPAM negative participants are not eligible)
  • Drug: FOG-001
    FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
  • Drug: mFOLFOX-6
    mFOLFOX-6 will be administered per the prescribing information in combination with FOG-001
    Other names:
    • Leucovorin, 5-fluorouracil, Oxaliplatin
  • Drug: Bevacizumab
    Bevacizumab will be administered per the prescribing information in combination with FOG-001
    Other names:
    • Avastin
Experimental
Part 2f-2 		Solid Tumors with documented WPAM or MSS CRC (known WPAM negative participants are not eligible)
  • Drug: FOG-001
    FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
  • Drug: Nivolumab
    Nivolumab will be administered per the prescribing information in combination with FOG-001
    Other names:
    • Opdivo
Experimental
Part 2f-3 		MSS CRC (known WPAM negative participants are not eligible)
  • Drug: FOG-001
    FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
  • Drug: Trifluridine/tipiracil
    Trifluridine/tipiracil will be administered per the prescribing information in combination with FOG-001
    Other names:
    • Lonsurf
  • Drug: Bevacizumab
    Bevacizumab will be administered per the prescribing information in combination with FOG-001
    Other names:
    • Avastin

Recruiting Locations

Honor Health
Scottsdale, Arizona 85258
Contact:
Sunil Sharma, MD
480-323-1350

Arizona Cancer Center at University of Arizona
Tucson, Arizona 85719
Contact:
Aaron Scott, MD
520-694-2873

University of California, Los Angeles (UCLA)
Los Angeles, California 90095
Contact:
Randy Hecht, MD
310-829-5471

Stanford Cancer Institute, Stanford University
Palo Alto, California 94304
Contact:
Nam Bui
650-498-6000

University of California San Francisco, Helen Diller Family Comprehensive Cancer Center
San Francisco, California 94158
Contact:
Varun Monga, MD
888-689-8273

Sarcoma Oncology Center
Santa Monica, California 90403
Contact:
Sant Chawla, MD
301-552-9999

University of Colorado
Aurora, Colorado 80045
Contact:
Breelyn Wilky, MD
305-243-1287

Yale University School of Medicine
New Haven, Connecticut 06520
Contact:
Michael Cecchini, MD
415-302-7807

Johns Hopkins University, Sibley Memorial Hospital
Washington D.C., District of Columbia 20016
Contact:
Mike J Pishvaian, MD/PhD
202-804-3343

Johns Hopkins University, The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland 21287
Contact:
Mike J Pishvaian, MD/PhD
410-955-8964

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Samuel Klempner, MD
617-724-4000

Dana Farber Cancer Institute
Boston, Massachusetts 02215
Contact:
Candace Haddox, MD
617-632-3000

M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota 55455
Contact:
Ajay Prakash, MD/PhD
612-273-8383

Washington University School of Medicine
St Louis, Missouri 63110
Contact:
Moh'd Khushman, MD
314-362-9115

Memorial Sloan Kettering Cancer Center
New York, New York 10065
Contact:
Rona Yaeger, MD
646-888-5109

University Hospitals Cleveland Medical Center, Seidman Cancer Center
Cleveland, Ohio 44106
Contact:
David Bajor, MD
216-765-9033

Cleveland Clinic
Cleveland, Ohio 44195
Contact:
Wen Wee Ma, MBBS
216-444-2200

Oregon Health and Science University
Portland, Oregon 97239
Contact:
Shivaani Kummar, MD
503-494-8534

University of Pittsburgh Medical Center, Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
Contact:
Dennis J Hsu, MD
412-623-1722

Sarah Cannon Research Institute
Nashville, Tennessee 37203
Contact:
Meredith S Pelster, MD
615-329-6862

Vanderbilt Ingram Cancer Center
Nashville, Tennessee 37232
Contact:
Kristen Ciombor, MD
615-322-3000

The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
Contact:
Jordi Rodon Ahnert, MD/PhD
713-792-5603

South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas 78229
Contact:
Kyriakos Papadopoulos, MD
210-593-5255

University of Virginia
Charlottesville, Virginia 22908
Contact:
Ludimila Cavalcante, MD
434-358-8780

University of Wisconsin, Carbone Cancer Center
Madison, Wisconsin 53705
Contact:
Jeremy Kratz, MD
608-263-1300

More Details

NCT ID
NCT05919264
Status
Recruiting
Sponsor
Parabilis Medicines, Inc.

Study Contact

Clinical Trial Inquiries
(857) 259-6305
clinicaltrials@parabilismed.com

Detailed Description

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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