This study will test the safety of a drug called PF-08046031 in participants with melanoma and other solid tumors that have no current approved treatment or have spread through the body. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease. The study will have 3 parts. Part A and B of the study will find out how much PF-08046031 should be given to participants. Part C will use the information from Parts A and B to see if PF-08046031 is safe and if it works to treat solid tumor cancers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Given into the vein (IV; intravenous)
The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate
Los Angeles, California, United States
The Angeles Clinic And Research Institute, A Cedars-Sinai Affiliate
Los Angeles, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
UCSF Medical Center, Investigational Pharmacy
San Francisco, California, United States
The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate (Emergency Back-up only)
Santa Monica, California, United States
Presbyterian/ St. Lukes Medical Center
Denver, Colorado, United States
Sarah Cannon Research Institute at HealthONE - SCRI - PPDS
Denver, Colorado, United States
Gustave Roussy
Villejuif, Val-de-marne, France
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], Spain
Karolinska Universitetssjukhuset Solna
Solna, Stockholms LÄN [se-01], Sweden
...and 1 more locations
Number of participants with adverse events (AEs)
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Time frame: through 30 days after the last study treatment; approximately 6 months
Number of participants with laboratory abnormalities
Time frame: through 30days after the last study treatment; approximately 6 months
Number of participants with dose limiting toxicities
Time frame: up to 28 days
number of participants with antidrug antibodies
To be summarized using descriptive statistics
Time frame: through 30 days after the last study treatment; approximately 6 months
Pharmacokinetic (PK) parameter - Area under the curve (AUC)
To be summarized using descriptive statistics
Time frame: Through 30 days after the last study treatment; approximately 6 months
PK parameter - Maximum Concentration (Cmax)
To be summarized using descriptive statistics
Time frame: Through 30 days after the last study treatment; approximately 6 months
PK parameter - Time to maximum concentration (Tmax)
To be summarized using descriptive statistics
Time frame: Through 30 days after the last study treatment; approximately 6 months
PK parameter - Apparent terminal half-life (t1/2)
To be summarized using descriptive statistics
Time frame: Through 30 days after the last study treatment; approximately 6 months
PK parameter - Trough concentration (Ctrough)
To be summarized using descriptive statistics
Time frame: Through 30 days after the last study treatment; approximately 6 months
Objective response rate (ORR)
The proportion of participants with a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as assessed by the investigato
Time frame: Up to approximately 1 year
Duration of response (DOR)
The time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of progressive disease (PD) (based on radiographic assessments per RECIST v1.1) or death due to any cause
Time frame: Up to approximately 1 year
Progression-free survival (PFS)
The time from the start of study treatment to the first documentation of PD (per RECIST v1.1 as assessed by the investigator) or death due to any cause
Time frame: Up to approximately 1 year
Overall survival (OS)
The time from the start of study treatment to death due to any cause
Time frame: Approximately 2 years
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