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| ID | Type | Description | Link |
|---|---|---|---|
| GPS [GPNMB-AurS] | Other Identifier | Alias Study Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Cohort 1 | Experimental | Participants will receive PF-08046033 dose level 1 intravenously (IV). |
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| Part 1: Cohort 2 | Experimental | Participants will receive PF-08046033 dose level 2 IV. |
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| Part 1: Cohort 3 | Experimental | Participants will receive PF-08046033 dose level 3 IV. |
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| Part 1: Cohort 4 | Experimental | Participants will receive PF-08046033 dose level 4 IV. |
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| Part 1: Cohort 5 | Experimental | Participants will receive PF-08046033 dose level 5 IV. |
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| Part 1: Cohort 6 | Experimental | Participants will receive PF-08046033 dose level 6 IV. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-08046033 | Drug | Powder for solution for infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| Type, incidence and severity of participants with adverse events (AEs) | 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). | From the first day through 30-37 days after the last study treatment, up to approximately 1 year |
| Type, incidence, and severity of participants with laboratory abnormalities | Type, incidence, and severity (graded by NCI CTCAE version 5.0) of laboratory abnormalities | From the first day through 30-37 days after the last study treatment, up to approximately 1 year |
| Number of participants with dose modifications | Frequency of dose modifications (eg, dose delay and treatment discontinuations) due to AEs | From the first day through 30-37 days after the last study treatment, up to approximately 1 year |
| Incidence of dose-limiting toxicities (DLTs) | To identify the maximum tolerated dose (MTD) or maximum administered dose (MAD) of PF-08046033 | From the first day through 30-37 days after the last study treatment, up to approximately 1 year |
| Recommended dose and schedule of PF-08046033 for expansion (RDE) | RDE will be based on cumulative safety, preliminary antitumor activity and pharmacokinetics findings | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by investigator | Objective response defined as Complete Response (CR) or Partial Response (PR) per RECIST v1.1, from the date of first dose until the date of the first documentation of PD, death, or start of new anticancer therapy, whichever occurs first. | Up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Presbyterian/St Lukes Medical Center | Recruiting | Denver | Colorado | 80218 | United States | |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D008545 | Melanoma |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Part 1: Cohort 7 | Experimental | Participants will receive PF-08046033 dose level 7 IV. |
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| Part 2: Cohort 1 Non-Small Cell Lung Cancer (NSCLC) | Experimental | PF-08046033: Specified dose IV on specified days |
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| Part 2: Cohort 2 Esophageal Squamous Cell Carcinoma (ESCC) | Experimental | PF-08046033: Specified dose IV on specified days |
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| Part 2: Cohort 3 (Cutaneous Melanoma) | Experimental | PF-08046033: Specified dose IV on specified days |
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| Duration of response (DOR) using RECIST v1.1 as assessed by investigator | DOR is defined as the time from first documentation of CR or PR to date of first documentation of PD or death due to any cause. | Up to 3 years |
| Progression-free survival (PFS) using RECIST v1.1 as assessed by investigator | Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective progressive disease (PD) assessed by investigator per RECIST 1.1, or death due to any cause, whichever occurs first. | Up to 3 years |
| Overall survival (OS) using RECIST v1.1 as assessed by investigator | Overall survival defined as the time from the date of randomization to the date of death due to any cause. | Up to 3 years |
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of PF-08046033 | To characterize the PK of PF-08046033 | From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, , Up to approximately 1 year |
| PK: Area under the concentration-time curve (AUC) of PF-08046033 | To characterize the PK of PF-08046033 | From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year |
| PK: Time to Maximum concentration (Tmax) of PF-08046033 | To characterize the PK of PF-08046033 | From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year |
| PK: Trough concentration (Ctrough) of PF-08046033 | To characterize the PK of PF-08046033 | From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year |
| PK: Terminal Elimination half-life (t1/2) of PF-08046033 | From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year |
| Incidence of antidrug antibodies (ADAs) | To characterize the immunogenicity of PF-08046033 | From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year |
| Percent change of immune cells and PD-L1 expression based on immunohistochemistry | To evaluate the pharmacodynamic effects of PF-08046033 in tumor tissue | From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year |
| Sarah Cannon Research Institute at HealthONE |
| Recruiting |
| Denver |
| Colorado |
| 80218 |
| United States |
| Sarah Cannon Research Institute- Pharmacy | Not yet recruiting | Nashville | Tennessee | 37203 | United States |
| SCRI Oncology Partners | Not yet recruiting | Nashville | Tennessee | 37203 | United States |
| Hospital Oncologico Dr. Isaac Gonzalez-Martinez | Recruiting | Rio Piedras | 00935 | Puerto Rico |
| Pan American Center for Oncology Trials, LLC | Recruiting | Rio Piedras | 00935 | Puerto Rico |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |