FOG-001 in Locally Advanced or Metastatic Solid Tumors

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Parabilis Medicines, Inc.
Study ID
NCT05919264
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FOG-001 — DRUG
    FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
  • mFOLFOX-6 — DRUG
    mFOLFOX-6 will be administered per the prescribing information in combination with FOG-001
  • Nivolumab — DRUG
    Nivolumab will be administered per the prescribing information in combination with FOG-001
  • Trifluridine/tipiracil — DRUG
    Trifluridine/tipiracil will be administered per the prescribing information in combination with FOG-001
  • Bevacizumab — DRUG
    Bevacizumab will be administered per the prescribing information in combination with FOG-001
  • FOG-001 — DRUG
    FOG-001 will be administered subcutaneous at assigned doses in continuous cycles of 28 days

Study Details

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.

Key Dates

Start date
May 23, 2023
Status verified
May 2026
Primary completion
Apr 1, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
595 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1a
    Solid Tumors with any WNT-Pathway Activating Mutation (WPAM) or Microsatellite Stable (MSS) Colorectal Cancer (CRC), irrespective of WPAM status
  • Experimental: Part 1b
    MSS CRC (known WPAM negative participants are not eligible)
  • Experimental: Part 1c
    Hepatocellular Carcinoma (documented WPAM in APC or CTNNB1 required)
  • Experimental: Part 1d-1
    Desmoid Tumors
  • Experimental: Part 1d-2
    Desmoid Tumors
  • Experimental: Part 1f-1
    MSS CRC (known WPAM negative participants are not eligible)
  • Experimental: Part 1f-2
    Solid Tumors with documented WPAM or MSS CRC (known WPAM negative participants are not eligible)
  • Experimental: Part 1f-3
    MSS CRC (known WPAM negative participants are not eligible)
  • Experimental: Part 1g
    Solid Tumors with documented WPAM (known WPAM negative participants are not eligible)
  • Experimental: Part 1h
    Desmoid Tumors
  • Experimental: Part 2a
    MSS CRC, irrespective of WPAM status
  • Experimental: Part 2b
    Solid Tumors with documented WPAM
  • Experimental: Part 2c
    Hepatocellular Carcinoma (documented WPAM in APC or CTNNB1 required)
  • Experimental: Part 2d
    Desmoid Tumors
  • Experimental: Part 2e
    Metastatic Castration-Resistant Prostate Cancer (documented WPAM in APC or CTNNB1 required)
  • Experimental: Part 2f-1
    MSS CRC (known WPAM negative participants are not eligible)
  • Experimental: Part 2f-2
    Solid Tumors with documented WPAM or MSS CRC (known WPAM negative participants are not eligible)
  • Experimental: Part 2f-3
    MSS CRC (known WPAM negative participants are not eligible)

Primary Outcome Measure

During dose escalation and dose expansion measure incidence and severity of treatment emergent adverse events by CTCAE v5.0 [ Time Frame: Through study completion, an average of 10 months ]

Central Contacts

Locations (31)

FacilityCityStateZIPSite coordinators
Mayo ClinicPhoenixArizona85054
Mahesh Seetharam, MD
480-301-8000
Honor HealthScottsdaleArizona85258
Sunil Sharma, MD
480-323-1350
Arizona Cancer Center at University of ArizonaTucsonArizona85719
Aaron Scott, MD
520-694-2873
University of California, Los Angeles (UCLA)Los AngelesCalifornia90095
Randy Hecht, MD
310-829-5471
Stanford Cancer Institute, Stanford UniversityPalo AltoCalifornia94304
Nam Bui
650-498-6000
University of California San Francisco, Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94158
Varun Monga, MD
888-689-8273
Sarcoma Oncology CenterSanta MonicaCalifornia90403
Sant Chawla, MD
301-552-9999
University of ColoradoAuroraColorado80045
Breelyn Wilky, MD
305-243-1287
Yale University School of MedicineNew HavenConnecticut06520
Michael Cecchini, MD
415-302-7807
Johns Hopkins University, Sibley Memorial HospitalWashington D.C.District of Columbia20016
Mike J Pishvaian, MD/PhD
202-804-3343
Mayo ClinicJacksonvilleFlorida32224
Conor O'Donnell, MD
904-953-6870
Florida Cancer SpecialistsLake MaryFlorida32746-
Johns Hopkins University, The Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21287
Mike J Pishvaian, MD/PhD
410-955-8964
Eric Christenson, MD
410-955-8964
Dana Farber Cancer InstituteBostonMassachusetts02215
Candace Haddox, MD
617-632-3000
Massachusetts General HospitalBostonMassachusetts02114
Samuel Klempner, MD
617-724-4000
M Health Fairview University of Minnesota Medical CenterMinneapolisMinnesota55455
Ajay Prakash, MD/PhD
612-273-8383
Mayo ClinicRochesterMinnesota55905
Hao Xie, MD
504-284-2511
Washington University School of MedicineSt LouisMissouri63110
Moh'd Khushman, MD
314-362-9115
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Rona Yaeger, MD
646-888-5109
Duke UniversityDurhamNorth Carolina27705
Niharika Mettu, MD
919-681-2954
Cleveland ClinicClevelandOhio44195
Wen Wee Ma, MBBS
216-444-2200
Dale Shepard, MD, PhD
(216) 444-2200
University Hospitals Cleveland Medical Center, Seidman Cancer CenterClevelandOhio44106
David Bajor, MD
216-765-9033
Oregon Health and Science UniversityPortlandOregon97239
Shivaani Kummar, MD
503-494-8534
University of Pennsylvania, Perelman School of MedicinePhiladelphiaPennsylvania19104
Mark O'Hara, MD
215-662-4646
University of Pittsburgh Medical Center, Hillman Cancer CenterPittsburghPennsylvania15232
Dennis J Hsu, MD
412-623-1722
Sarah Cannon Research InstituteNashvilleTennessee37203
Meredith S Pelster, MD
615-329-6862
Vanderbilt Ingram Cancer CenterNashvilleTennessee37232
Kristen Ciombor, MD
615-322-3000
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Jordi Rodon Ahnert, MD/PhD
713-792-5603
South Texas Accelerated Research Therapeutics, LLCSan AntonioTexas78229
Kyriakos Papadopoulos, MD
210-593-5255
University of VirginiaCharlottesvilleVirginia22908
Ludimila Cavalcante, MD
434-358-8780
University of Wisconsin, Carbone Cancer CenterMadisonWisconsin53705
Jeremy Kratz, MD
608-263-1300

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