Phase 1 Study of PF-08046033 in Advanced Solid Tumors

Condition(s) studied

Investigational drug(s) / intervention(s)

PF-08046033: Powder for solution for infusion.

Study 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

Primary outcome measure(s)

• Type, incidence and severity of participants with adverse events (AEs) — From the first day through 30-37 days after the last study treatment, up to approximately 1 year
  Type, incidence, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] v 5.0), seriousness, and relatedness of adverse events (AEs).
• Type, incidence, and severity of participants with laboratory abnormalities — From the first day through 30-37 days after the last study treatment, up to approximately 1 year
  Type, incidence, and severity (graded by NCI CTCAE version 5.0) of laboratory abnormalities
• Number of participants with dose modifications — From the first day through 30-37 days after the last study treatment, up to approximately 1 year
  Frequency of dose modifications (eg, dose delay and treatment discontinuations) due to AEs
• Incidence of dose-limiting toxicities (DLTs) — From the first day through 30-37 days after the last study treatment, up to approximately 1 year
  To identify the maximum tolerated dose (MTD) or maximum administered dose (MAD) of PF-08046033
• Recommended dose and schedule of PF-08046033 for expansion (RDE) — Up to 1 year
  RDE will be based on cumulative safety, preliminary antitumor activity and pharmacokinetics findings

Trial sites (15)

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