A Study to Learn About How Different Amounts of the Study Medicine PF-07826390 Act in the Body of People With Cancer When Taken Alone or With Other Anti-cancer Medicines.
NCT Number: NCT06546553
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Neoplasms|Non-small-cell Lung Cancer|Squamous Cell Carcinoma of the Head and Neck|Renal Cell Carcinoma|Colorectal Carcinoma|Ovarian Carcinoma
Interventions: DRUG: PF-07826390|BIOLOGICAL: sasanlimab|OTHER: SOC (anti-PD-1 + platinum -based chemo)
Sponsor: Pfizer
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 190
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-05
Completion Date: 2030-02-28

Summary:
The purpose of this study is to learn about the:

* safety (the effect of the study medicine on the participant's body),
* effects of the study medicine alone or in combination with sasanlimab -
* the best amount of the study medicine.

This study is seeking participants who have solid tumors (An abnormal mass of tissue) that:

* have advanced (cancer that does not disappear or stay away with treatment) or
* are metastatic (has spread to other parts of the body).

This includes (but limited to) the following cancer types:

* Non-Small Cell Lung Cancer (NSCLC): It's a type of lung cancer where the cells grow slowly but often spread to other parts of the body.
* Colorectal Cancer (CRC): This is a disease where cells in the colon or rectum grow out of control.
* Renal Cell Carcinoma (RCC): This is a cancer that starts in the kidney.

All participants in this study will receive the study medication (PF-07826390) as an IV infusion (given directly into a vein) at the study once every four weeks in 28 day cycles.

The study participants depending on the group enrolled in, will receive the study medication (PF-07826390 alone or in combination with other anti-cancer medications (sasanlimab). Sasanlimab is given as a shot under the skin every 4 weeks.

Participants can continue to take the study medication (PF-07826390) until their cancer is no longer responding. Participants who are taking sasanlimab may receive it for up to 2 years.

The study will look at the experiences of people receiving the study medicines. This will help see if the study medicines are safe and effective.

Participants will be involved in this study for up to 4 years. During this time, participants will have a study visit every week. The participants after stopping the study medicine (at about 2 years) will be followed for another two years to see how the participants are doing.

Primary Outcome Measures: PART 1: Number of participants with Dose-limiting toxicities (DLT), Any of the prespecified AEs that are attributable to one, the other, or both study treatments, occurring in the DLT observation period are considered DLTs, excluding toxicities clearly due to underlying disease or extraneous causes., First cycle, Day 1 up to Day 28|PART 1 & 2: Incidence of Adverse Events (AE)s, An adverse event (AE) is any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it. SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. AEs included both serious and all non-serious AEs., From start of the treatment and up to 90 days after last dose or start of new anticancer therapy, whichever occurred first.|PART 1 & 2: Number of participants with laboratory abnormalities, Number of participants with laboratory test abnormalities. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick and microscopy)., From start of the treatment and up to 90 days after last dose or start of new anticancer therapy, whichever occurred first.|Part 2: Objective Response - Number of Participants With Objective Response, Percentage of participants with objective response-based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by the Investigator., Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion, approximately 2 years.
Secondary Outcome Measures: Objective Response - Number of Participants with Objective Response, Percentage of participants with objective response-based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by the Investigator, Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion, approximately 2 years|Time to event endpoints: duration of response (DOR) by RECIST v1.1, Time to event: DOR according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) as assessed by the Investigator., Baseline to confirmed disease progression, up to 2 years after the last dose of study treatment|Time to event endpoints: progression-free survival (PFS) by RECIST v1.1, Time to event: PFS according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) as assessed by the Investigator., Baseline to confirmed disease progression, up to 2 years after the last dose of study treatment|Part 1: Maximum Observed Serum Concentration (Cmax), Cycle 1: Pre-dose, 1, 4, 8, 24, 48, 168, 336 and 504 hours post dose. Cycle 2: Pre-dose and 336 hours post dose. Cycle 3: Pre-dose, 1, 4, 24, 168 and 336 hours post dose. Cycle 3 and beyond Pre-dose only., Cycle 1 Day 1, 2, 3, 8, 15 and 22; Cycle 2 Day 1 and 15; Cycle 3+ Day 1 (each cycle is 28 days)|Part 1: Time to Reach Maximum Serum Concentration (Tmax) of PF-07826390, Cycle 1: Pre-dose, 1, 4, 8, 24, 48, 168, 336 and 504 hours post dose. Cycle 2: Pre-dose and 336 hours post dose. Cycle 3: Pre-dose, 1, 4, 24, 168 and 336 hours post dose. Cycle 3 and beyond Pre-dose only., Cycle 1 Day 1, 2, 3, 8, 15 and 22; Cycle 2 Day 1 and 15; Cycle 3+ Day 1 (each cycle is 28 days)|Part 1: Serum Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-07826390, Cycle 1: Pre-dose, 1, 4, 8, 24, 48, 168, 336 and 504 hours post dose. Cycle 2: Pre-dose and 336 hours post dose. Cycle 3: Pre-dose, 1, 4, 24, 168 and 336 hours post dose. Cycle 3 and beyond Pre-dose only., Cycle 1 Day 1, 2, 3, 8, 15 and 22; Cycle 2 Day 1 and 15; Cycle 3+ Day 1 (each cycle is 28 days)|Part 1: Serum Area Under the Curve From Time Zero to Last Time Zero to clearance (CL/F) of PF-07826390, Cycle 1: Pre-dose, 1, 4, 8, 24, 48, 168, 336 and 504 hours post dose. Cycle 2: Pre-dose and 336 hours post dose. Cycle 3: Pre-dose, 1, 4, 24, 168 and 336 hours post dose. Cycle 3 and beyond Pre-dose only., Cycle 1 Day 1, 2, 3, 8, 15 and 22; Cycle 2 Day 1 and 15; Cycle 3+ Day 1 (each cycle is 28 days)|Part 1: Serum under the curve apparent volume of distribution during terminal phase (Vz/F) of PF-07826390, Cycle 1: Pre-dose, 1, 4, 8, 24, 48, 168, 336 and 504 hours post dose. Cycle 2: Pre-dose and 336 hours post dose. Cycle 3: Pre-dose, 1, 4, 24, 168 and 336 hours post dose. Cycle 3 and beyond Pre-dose only., Cycle 1 Day 1, 2, 3, 8, 15 and 22; Cycle 2 Day 1 and 15; Cycle 3+ Day 1 (each cycle is 28 days)|Part 1: Serum under the curve terminal elimination half life (T ½) of PF-07826390, Cycle 1: Pre-dose, 1, 4, 8, 24, 48, 168, 336 and 504 hours post dose. Cycle 2: Pre-dose and 336 hours post dose. Cycle 3: Pre-dose, 1, 4, 24, 168 and 336 hours post dose. Cycle 3 and beyond Pre-dose only., Cycle 1 Day 1, 2, 3, 8, 15 and 22; Cycle 2 Day 1 and 15; Cycle 3+ Day 1 (each cycle is 28 days)|Part 1 and Part 2: Serum Concentrations of PF-07826390 in combination (Part 1B, 2A and 2C), Day 1 (all cycles) and EOT., Prior to dosing at Cycle 1+ Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days)|Part 1 and Part 2: Incidence and titers of antidrug antibodies (ADA) against PF-07826390, Day 1 (all cycles) and end of treatment, Prior to dosing at Cycle 1+ Day 1 up to end of study treatment, approximately 2 years (each cycle is 28 days)|Part 1 and Part 2: Paried Tumor Biopsies, Pre-dose and C2 Day 15, Baseline through Cycle 2 Day 15 (each cycle is 28 days)|Part 2: Time to Reach Maximum Serum Concentration (Tmax) of PF-07826390, Cycle 1, 2 and 3: Pre-dose, 1, 24, and 336 hours post dose. Cycle 4 and beyond Pre-dose only., Cycle 1 Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days)|Part 2: Maximum Observed Serum Concentration (Cmax) of PF-07826390, Cycle 1, 2 and 3: Pre-dose, 1, 24, and 336 hours post dose. Cycle 4 and beyond Pre-dose only., Cycle 1 Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days)|Part 1: Pharmacodynamic blood samples: Receptor occupancy, Cycle 1: Pre-dose, 48, 168 and 336 hours post dose. Cycle 2: Pre-dose and 336 hours post dose. Cycle 3 and beyond pre-dose only., Cycle 1 Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days)|Part 2: Pharmacodynamic blood samples Receptor Occupancy, Cycle 1: Pre-dose, 24 and 336 hours post dose, Cycle 2: Pre-dose, 24 and 336 hours post dose. Cycle 3 and beyond pre-dose only., Cycle 1 Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days)|Part 2: Serum Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-07826390, Cycle 1, Cycle 2 and Cycle 3: Pre-dose, 1, 24 and 336 hours post dose., Cycle 1 Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days)|Part 2: Serum Area Under the Curve From Time Zero to clearance (CL/F) of PF-07826390, Cycle 1, Cycle 2 and Cycle 3: Pre-dose, 1, 24 and 336 hours post dose., Cycle 1 Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days)|Part 2: Serum under the curve apparent volume of distribution during terminal phase (Vz/F) of PF-07826390, Cycle 1, Cycle 2 and Cycle 3: Pre-dose, 1, 24 and 336 hours post dose., Cycle 1 Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days)|Part 2: Serum under the curve terminal elimination half life (T ½) of PF-07826390, Cycle 1, Cycle 2 and Cycle 3: Pre-dose, 1, 24 and 336 hours post dose., Cycle 1 Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days)