Phase 1 Study of PF-08046033 in Advanced Solid Tumors

Part of paid clinical trials in Denver, Colorado.

Sponsor
Pfizer
Study ID
NCT07519655
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • PF-08046033 — DRUG
    Powder for solution for infusion.

Study Details

This is an early-stage (Phase 1) clinical study testing a new study medicine called PF-08046033. The goal of the study is to understand how safe the medicine is, how well people tolerate it, how it behaves in the body, and whether it shows early signs of helping to treat cancer. The study includes adult participants who have advanced cancers that cannot be removed by surgery or have spread to other parts of the body. These cancers include non-small cell lung cancer, esophageal squamous cell cancer, and melanoma. The study has two parts: In the first part, small groups of participants receive increasing doses of the study medicine. This helps researchers find a dose that is safe and suitable for further testing. Once a suitable dose is identified, the second part enrolls more participants with specific cancer types to better understand the safety of the medicine and whether it shows signs of helping control the cancer. Participants receive the study medicine through regular treatment cycles and are closely monitored for side effects and how their cancer responds. The information from this study will help researchers decide whether PF-08046033 should be studied further in later-stage clinical trials.

Key Dates

Start date
Apr 8, 2026
Status verified
Apr 2026
Primary completion
Jul 14, 2028
Completion
Jul 14, 2029

Study Design

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

Arms

  • Experimental: Part 1: Cohort 1
    Participants will receive PF-08046033 dose level 1 intravenously (IV).
  • Experimental: Part 1: Cohort 2
    Participants will receive PF-08046033 dose level 2 IV.
  • Experimental: Part 1: Cohort 3
    Participants will receive PF-08046033 dose level 3 IV.
  • Experimental: Part 1: Cohort 4
    Participants will receive PF-08046033 dose level 4 IV.
  • Experimental: Part 1: Cohort 5
    Participants will receive PF-08046033 dose level 5 IV.
  • Experimental: Part 1: Cohort 6
    Participants will receive PF-08046033 dose level 6 IV.
  • Experimental: Part 1: Cohort 7
    Participants will receive PF-08046033 dose level 7 IV.
  • Experimental: Part 2: Cohort 1 Non-Small Cell Lung Cancer (NSCLC)
    PF-08046033: Specified dose IV on specified days
  • Experimental: Part 2: Cohort 2 Esophageal Squamous Cell Carcinoma (ESCC)
    PF-08046033: Specified dose IV on specified days
  • Experimental: Part 2: Cohort 3 (Cutaneous Melanoma)
    PF-08046033: Specified dose IV on specified days

Primary Outcome Measure

Type, incidence and severity of participants with adverse events (AEs) [ Time Frame: From the first day through 30-37 days after the last study treatment, up to approximately 1 year ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Presbyterian/St Lukes Medical CenterDenverColorado80218-
Sarah Cannon Research Institute at HealthONEDenverColorado80218-
Sarah Cannon Research Institute- PharmacyNashvilleTennessee37203-
SCRI Oncology PartnersNashvilleTennessee37203-

Find similar trials in Denver, CO

By condition
Esophageal cancer
By specialty
OncologyGI oncology
By research site
Presbyterian/St Lukes Medical Center· Denver, COSarah Cannon Research Institute at HealthONE· Denver, COSarah Cannon Research Institute- Pharmacy· Nashville, TNSCRI Oncology Partners· Nashville, TN

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