A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Seagen, a wholly owned subsidiary of Pfizer
Study ID
NCT06131840
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • PF-08046050 — DRUG
    Given into the vein (IV; intravenous)
  • bevacizumab — DRUG
    Given into the vein (IV; intravenous)
  • 5-Fluorouracil (5-FU) — DRUG
    Given into the vein (IV; intravenous)
  • Oxaliplatin — DRUG
    Given into the vein (IV; intravenous)
  • Leucovorin (LV) — DRUG
    Given into the vein (IV; intravenous)

Study Details

This clinical trial is studying advanced solid tumors. Solid tumors are cancers that start in a part of your body like your lungs or liver instead of your blood. Once tumors have grown bigger in one place but haven't spread, they're called locally advanced. If your cancer has spread to other parts of your body, it's called metastatic. When a cancer has gotten so big it can't easily be removed or has spread to other parts of the body, it is called unresectable. These types of cancer are harder to treat. Participants in this study must have cancer that has come back or did not get better with treatment. Participants must have a solid tumor cancer that can't be treated with standard of care drugs. This clinical trial uses an experimental drug called PF-08046050. PF-08046050 is a type of antibody-drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. They may also stick to some normal cells. This study will test the safety of PF-08046050 in participants with solid tumors that are hard to treat or have spread throughout the body. This study has 5 different study parts. Part A and Part B of the study will find out how much PF-08046050 should be given to participants. Part C will use the information from Parts A and B to see if PF-08046050 is safe and if it works to treat certain solid tumor cancers. Part D and E of the study, together with information from Parts A and B, will find out how much PF-08046050 should be given in combination with other anti-cancer agents. Part E will use the information from Parts A, B, and D to see if PF-08046050 is safe in combination with other anti-cancer agents and if it works to treat a certain solid tumor.

Key Dates

Start date
Nov 20, 2023
Status verified
Apr 2026
Primary completion
Sep 12, 2029
Completion
Sep 12, 2030

Study Design

Enrollment
914 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: PF-08046050
    PF-08046050 monotherapy
  • Experimental: PF-08046050 +bevacizumab
    PF-08046050 combination with bevacizumab
  • Experimental: PF-08046050 + bevacizumab + 5FU/LV
    PF-08046050 combination with bevacizumab + 5FU/LV
  • Experimental: PF-08046050 + 5FU/LV + oxaliplatin + bevacizumab
    PF-08046050 combination with 5FU/LV + oxaliplatin + bevacizumab
  • Experimental: PF-08046050 + 5FU/LV + oxaliplatin
    PF-08046050 combination with 5FU/LV + oxaliplatin
  • Experimental: PF-08046050 + 5FU/LV
    PF-08046050 combination with 5FU/LV

Primary Outcome Measure

Number of participants with adverse events (AEs) [ Time Frame: Through 30-37 days after the last study treatment, up to approximately 2 years ]

Central Contacts

Locations (21)

FacilityCityStateZIPSite coordinators
Mayo Clinic HospitalPhoenixArizona85054-
Mayo ClinicScottsdaleArizona85259-
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)DuarteCalifornia91010-
IP Address: City of Hope Investigational Drug Services(IDS)DuarteCalifornia91010-
University of Colorado HospitalAuroraColorado80045-
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)AuroraColorado80045-
Florida Cancer SpecialistsOrlandoFlorida32827-
Sarah Cannon Research Institute at Florida Cancer SpecialistsOrlandoFlorida32827-
Sidney Kimmel Comprehensive Cancer at Johns HopkinsBaltimoreMaryland21287-
The Johns Hopkins UniversityBaltimoreMaryland21287-
Beth Israel Deaconess Medical CenterBostonMassachusetts02115-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
START MidwestGrand RapidsMichigan49546-
Mayo ClinicRochesterMinnesota55905-
Mayo Clinic Cancer CenterRochesterMinnesota55905-
Sarah Cannon Research Institute - PharmacyNashvilleTennessee37203-
SCRI Oncology PartnersNashvilleTennessee37203-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
South Texas Accelerated Research Therapeutics, LLCSan AntonioTexas78229-
START Mountain RegionSalt Lake CityUtah84119-
South Texas Accelerated Research Therapeutics Mountain RegionWest Valley CityUtah84119-

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