RightFit
RecruitingPhase 1

Phase 1 Study of PF-08046033 in Advanced Solid Tumors

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early-stage study tests PF-08046033, a new cancer medicine, in adults with certain advanced lung, esophagus, or skin cancers. It checks safety, side effects, how the medicine acts in the body, and early signs that it may help treat cancer. Researchers first test increasing doses, then test a suitable dose in more people.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are an adult with non-small cell lung cancer, squamous cell cancer of the esophagus (food tube), or melanoma of the skin, confirmed by a tissue test.
  • Your cancer has spread to other parts of the body or has grown nearby and cannot be removed by surgery.
  • In Part 1, your cancer got worse on standard treatments, or you could not tolerate them. In Part 2, this applies to 1–2 past treatments that work throughout the body.
  • Your cancer can be measured.
  • You can do all your usual activities, or you have trouble only with hard physical activity (ECOG score 0–1).

Who can't join

  • You have known, active cancer spread to the brain or spinal cord.
  • You have moderate or worse nerve damage, which may cause numbness, tingling, or pain (grade 2 or higher).
  • You have uncontrolled diabetes with an A1C of 10% or higher, a blood test showing average blood sugar.
  • You have an untreated, serious condition caused by blood clots.
  • You have had treatment targeting a protein called GPNMB.
  • You have a known or suspected allergy to any ingredient in the study medicine.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Participants must have histologically-confirmed metastatic or unresectable locally advanced NSCLC, ESCC, or cutaneous melanoma. 2. 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). 3. Participants must have measurable disease. 4. Eastern Cooperative Oncology Group (ECOG) performance status is 0-1. Exclusion Criteria: 1. Participants with known clinically active central nervous system (CNS) metastases. 2. Participants with pre-existing neuropathy ≥Grade 2 per NCI CTCAE v 5.0. 3. Uncontrolled diabetes mellitus with hemoglobin (Hgb) A1C ≥10.0%. 4. Untreated clinically significant thromboembolic disease. 5. Previous exposure to GPNMB-targeted therapy. 6. Known or suspected hypersensitivity to any component or excipient contained in the drug formulation of study intervention.

Study sites (11)

CO

CT

TN

VA