The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.
Important Notice Regarding the Scientific Information You Have Requested
You are being redirected to the scientific presentations section. The information provided here relate to investigational assets. The safety and efficacy of the unapproved assets has not been proven.
Please acknowledge that you understand this before proceeding.
Other or Multiple Cancer Types
PF-08046033 |GPS is an investigational compound. Its safety and efficacy have not been established.
Active enrolling
United States, Puerto Rico, South Korea
for more information at clinicaltrials.gov
EXPERIMENTAL: Part 1: Cohort 1
Participants will receive PF-08046033 dose level 1 intravenously (IV).
DRUG: PF-08046033
Powder for solution for infusion.
EXPERIMENTAL: Part 1: Cohort 2
Participants will receive PF-08046033 dose level 2 IV.
DRUG: PF-08046033
Powder for solution for infusion.
EXPERIMENTAL: Part 1: Cohort 3
Participants will receive PF-08046033 dose level 3 IV.
DRUG: PF-08046033
Powder for solution for infusion.
EXPERIMENTAL: Part 1: Cohort 4
Participants will receive PF-08046033 dose level 4 IV.
DRUG: PF-08046033
Powder for solution for infusion.
EXPERIMENTAL: Part 1: Cohort 5
Participants will receive PF-08046033 dose level 5 IV.
DRUG: PF-08046033
Powder for solution for infusion.
EXPERIMENTAL: Part 1: Cohort 6
Participants will receive PF-08046033 dose level 6 IV.
DRUG: PF-08046033
Powder for solution for infusion.
EXPERIMENTAL: Part 1: Cohort 7
Participants will receive PF-08046033 dose level 7 IV.
DRUG: PF-08046033
Powder for solution for infusion.
EXPERIMENTAL: Part 2: Cohort 1 Non-Small Cell Lung Cancer (NSCLC)
PF-08046033: Specified dose IV on specified days
DRUG: PF-08046033
Powder for solution for infusion.
EXPERIMENTAL: Part 2: Cohort 2 Esophageal Squamous Cell Carcinoma (ESCC)
PF-08046033: Specified dose IV on specified days
DRUG: PF-08046033
Powder for solution for infusion.
EXPERIMENTAL: Part 2: Cohort 3 (Cutaneous Melanoma)
PF-08046033: Specified dose IV on specified days
DRUG: PF-08046033
Powder for solution for infusion.
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.
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.
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
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
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
250
Sponsor: Pfizer
Collaborator: None
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number:
NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
NCT07519655
Back
