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A Phase 1 Study to Investigate PF-08046033 in Participants With Advanced Solid Tumors

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participants must have histologically-confirmed metastatic or unresectable locally advanced NSCLC, ESCC, or cutaneous melanoma.

• Participants must have disease that has progressed on or be unable to tolerate standard treatments (Part 1) or 1-2 prior systemic therapies (Part 2).

• Participants must have measurable disease.

• Eastern Cooperative Oncology Group (ECOG) performance status is 0-1.

Locations
United States
Colorado
Presbyterian/St Lukes Medical Center
RECRUITING
Denver
Sarah Cannon Research Institute at HealthONE
RECRUITING
Denver
Tennessee
Sarah Cannon Research Institute- Pharmacy
NOT_YET_RECRUITING
Nashville
SCRI Oncology Partners
NOT_YET_RECRUITING
Nashville
Other Locations
Puerto Rico
Hospital Oncologico Dr. Isaac Gonzalez-Martinez
RECRUITING
Rio Piedras
Pan American Center for Oncology Trials, LLC
RECRUITING
Rio Piedras
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2026-04-08
Estimated Completion Date: 2029-07-14
Participants
Target number of participants: 250
Treatments
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
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov

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