Phase 1 Study of PF-08046033 in Advanced Solid Tumors

Pfizer

Status and phase: Enrolling; Phase 1

Conditions: Non-Small-Cell Lung; Esophageal Cancer; Cutaneous Melanoma

Treatments: Drug: PF-08046033

Study type: Interventional

Funder types: Industry

Identifiers

NCT07519655

GPS [GPNMB-AurS] (Other Identifier)

C5921001

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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250 participants in 10 patient groups

Part 1: Cohort 1

Experimental group

Description:

Participants will receive PF-08046033 dose level 1 intravenously (IV).

Treatment:

Drug: PF-08046033

Part 1: Cohort 2

Experimental group

Description:

Participants will receive PF-08046033 dose level 2 IV.

Treatment:

Drug: PF-08046033

Part 1: Cohort 3

Experimental group

Description:

Participants will receive PF-08046033 dose level 3 IV.

Treatment:

Drug: PF-08046033

Part 1: Cohort 4

Experimental group

Description:

Participants will receive PF-08046033 dose level 4 IV.

Treatment:

Drug: PF-08046033

Part 1: Cohort 5

Experimental group

Description:

Participants will receive PF-08046033 dose level 5 IV.

Treatment:

Drug: PF-08046033

Part 1: Cohort 6

Experimental group

Description:

Participants will receive PF-08046033 dose level 6 IV.

Treatment:

Drug: PF-08046033

Part 1: Cohort 7

Experimental group

Description:

Participants will receive PF-08046033 dose level 7 IV.

Treatment:

Drug: PF-08046033

Part 2: Cohort 1 Non-Small Cell Lung Cancer (NSCLC)

Experimental group

Description:

PF-08046033: Specified dose IV on specified days

Treatment:

Drug: PF-08046033

Part 2: Cohort 2 Esophageal Squamous Cell Carcinoma (ESCC)

Experimental group

Description:

PF-08046033: Specified dose IV on specified days

Treatment:

Drug: PF-08046033

Part 2: Cohort 3 (Cutaneous Melanoma)

Experimental group

Description:

PF-08046033: Specified dose IV on specified days

Treatment:

Drug: PF-08046033