A Clinical Trial of PF-08046037 Alone or With Sasanlimab in Patients With Advanced or Metastatic Malignancies
- Conditions
- Carcinoma, Non Small Cell LungSquamous Cell Carcinoma of the Head and Neck (SCCHN)Carcinoma, Pancreatic DuctalMalignant Melanoma
- Interventions
- Registration Number
- NCT06974734
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to learn about the safety and the effects of PF-08046037 alone or with sasanlimab for the treatment of certain advanced or metastatic malignancies.
This study is seeking participants who:
* have advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, or pancreatic ductal adenocarcinoma (PDAC);
* are able to provide tumor tissue samples;
* have measurable disease. All participants will receive while at the clinic PF-08046037 alone as an intravenous (IV) infusion (given directly into a vein) or with sasanlimab as a subcutaneous (SQ) injection (given under the skin) once every 3 weeks.
Participants will continue to take the study drug(s) until their cancer is no longer responding or if the patient cannot safely take them. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 399
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1a PF-08046037 PF-08046037 monotherapy dose escalation Part 2a PF-08046037 PF-08046037 monotherapy dose optimization Part 3a PF-08046037 PF-08046037 monotherapy dose expansion Part 1b PF-08046037 PF-08046037 +sasanlimab dose escalation Part 1b sasanlimab PF-08046037 +sasanlimab dose escalation Part 2b sasanlimab PF-08046037 + sasanlimab dose optimization Part 2b PF-08046037 PF-08046037 + sasanlimab dose optimization Part 3b PF-08046037 PF-08046037 + sasanlimab dose expansion Part 3b sasanlimab PF-08046037 + sasanlimab dose expansion
- Primary Outcome Measures
Name Time Method Number of participants with DLTs by dose level Up to 21 days Number of participants with adverse events (AEs) Through 30-37 days after the last study treatment, up to approximately 2 years An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention
Number of participants with laboratory abnormalities Through 30-37 days after the last study treatment, up to approximately 2 years Number of dose modifications due to AEs Through end of treatment up to approximately 2 years Number of participants with dose-limiting toxicities (DLTs) Up to 21 days
- Secondary Outcome Measures
Name Time Method PK parameter - Trough concentration (Ctrough) Through 30-37 days after the last study treatment, up to approximately 2 years PK endpoint
Number of participants with antidrug antibodies (ADAs) Through 30-37 days after the last study treatment, up to approximately 2 years Objective response rate (ORR) Through end of study and up to approximately 2 years The objective response rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) which is subsequently confirmed as assessed according to Response Evaluation in Solid Tumors (RECIST) v1.1.
Best overall response Through end of study and up to approximately 2 years The best overall response for a participant will be determined by the order of confirmed CR, confirmed PR, stable disease (SD), progressive disease (PD), not evaluable (NE) or not applicable (NA) per RECIST v1.1.
Duration of response (DOR) Through end of study and up to approximately 2 years DOR is defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression per RECIST v1.1 or to death due to any cause
Progression-free survival (PFS) Through end of study and up to approximately 2 years PFS is defined as the time from start of PF-08046037 to first documentation of disease progression (based on radiographic assessments per RECIST v1.1) or death due to any cause, whichever comes first
Overall survival (OS) Through end of study and up to approximately 2 years OS is defined as the time from start of PF-08046037 to date of death due to any cause
Percent change of cells within tumors based on multiplex immunofluorescence Through end of study and up to approximately 2 years This measure will assess the number of immune cells, PD-1, PD-L1, and TLR7 expression within the tumor microenvironment.
Pharmacokinetic (PK) parameter - Area under the concentration-time curve (AUC) Through 30-37 days after the last study treatment, up to approximately 2 years PK endpoint
PK parameter - Maximum concentration (Cmax) Through 30-37 days after the last study treatment, up to approximately 2 years PK endpoint
PK parameter - Time to maximum concentration (Tmax) Through 30-37 days after the last study treatment, up to approximately 2 years PK endpoint
PK parameter - t1/2 Through 30-37 days after the last study treatment, up to approximately 2 years PK endpoint
Trial Locations
- Locations (1)
START Midwest
🇺🇸Grand Rapids, Michigan, United States