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 ID: NCT06546553
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
9 participants
INTERVENTIONAL
2024-09-06
2025-10-03
Brief Summary
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* 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1A: PF-07826390 Monotherapy
PF-07826390 monotherapy at prescribed dose and frequency in 28-day cycles
PF-07826390
PF-07826390 is a novel, fully humanized bispecific IgG1 that targets the leukocyte immunoglobulin-like receptor, LILRB1 and LILRB2 (B1 and B2) cell-surface receptors
Part 1B: PF-07826390 + sasanlimab
PF-07826390 + sasanlimab at prescribed dose and frequency in 28-day cycles
PF-07826390
PF-07826390 is a novel, fully humanized bispecific IgG1 that targets the leukocyte immunoglobulin-like receptor, LILRB1 and LILRB2 (B1 and B2) cell-surface receptors
sasanlimab
A monoclonal antibody that blocks the interaction between PD-1 and PD-L1/L2
Part 2A (Arm 1): PF-07826390 + sasanlimab
PF-07826390 + sasanlimab dose expansion in NSCLC 2L+ at prescribed dose and frequency in 28-day cycles
PF-07826390
PF-07826390 is a novel, fully humanized bispecific IgG1 that targets the leukocyte immunoglobulin-like receptor, LILRB1 and LILRB2 (B1 and B2) cell-surface receptors
sasanlimab
A monoclonal antibody that blocks the interaction between PD-1 and PD-L1/L2
Part 2A (Arm 2): PF-07826390 + sasanlimab
PF-07826390 + sasanlimab dose expansion in MSS CRC 2L+ at prescribed dose and frequency in 28-day cycles
PF-07826390
PF-07826390 is a novel, fully humanized bispecific IgG1 that targets the leukocyte immunoglobulin-like receptor, LILRB1 and LILRB2 (B1 and B2) cell-surface receptors
sasanlimab
A monoclonal antibody that blocks the interaction between PD-1 and PD-L1/L2
Part 2A (Arm 3): PF-07826390 + sasanlimab
PF-07826390 + sasanlimab dose expansion in RCC 2L+ at prescribed dose and frequency in 28-day cycles
PF-07826390
PF-07826390 is a novel, fully humanized bispecific IgG1 that targets the leukocyte immunoglobulin-like receptor, LILRB1 and LILRB2 (B1 and B2) cell-surface receptors
sasanlimab
A monoclonal antibody that blocks the interaction between PD-1 and PD-L1/L2
Part 2B: PF-07826390
PF-07826390 dose expansion in NSCLC 2L+ at prescribed dose and frequency in 28-day cycles
PF-07826390
PF-07826390 is a novel, fully humanized bispecific IgG1 that targets the leukocyte immunoglobulin-like receptor, LILRB1 and LILRB2 (B1 and B2) cell-surface receptors
Part 2C: PF-07826390 + SOC
PF-07826390 + SOC (anti-PD-1 + platinum -based chemo) dose expansion for a PDx-naive NSCLC 1L at prescribed dose and frequency in 28-day cycles
PF-07826390
PF-07826390 is a novel, fully humanized bispecific IgG1 that targets the leukocyte immunoglobulin-like receptor, LILRB1 and LILRB2 (B1 and B2) cell-surface receptors
SOC (anti-PD-1 + platinum -based chemo)
Standard of Care (anti-PD-1 + platinum -based chemo)
Interventions
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PF-07826390
PF-07826390 is a novel, fully humanized bispecific IgG1 that targets the leukocyte immunoglobulin-like receptor, LILRB1 and LILRB2 (B1 and B2) cell-surface receptors
sasanlimab
A monoclonal antibody that blocks the interaction between PD-1 and PD-L1/L2
SOC (anti-PD-1 + platinum -based chemo)
Standard of Care (anti-PD-1 + platinum -based chemo)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Part 1A: Participants with solid tumors where anti-PD-(L)1 is an established treatment. Participants must have progressed on or following prior anti-PD-(L)1 therapy if approved, available, tolerable, and eligible
* Part 1B: Participants either meeting Part 1A criterion, or participants with "cold" solid tumors where anti-PD-(L)1 therapy is not an established treatment
* Part 2: Participants with NSCLC (2A Arm 1 and 2B) must have received platinum-based chemotherapy and anti-PD-(L)1 or have intolerability to or refusal of standard therapies. Participants with NSCLC who have not been previously treated with a prior anti-pd-(L) will be enrolled in Part 2C.
* Participants with MSS CRC (Part 2A Arm 2) must have received fluoropyrimidine-, oxaliplatin, and irinotecan-based chemotherapy, an anti-VEGF agent and anti-EGFR inhibitor (if RAS wildtype) and/or other molecularly targeted therapy if appropriate. Participants with RCC (Part 2A Arm 3) must have received prior tyrosine kinase inhibitor (TKI), anti-PD-(L)1 (if not receiving anti-PD-1 on protocol), anti-CTLA-4 (optional), hypoxia-inducible factor 2 alpha (HIF2a) inhibitor, or mTOR inhibitor or have documented intolerance to the standard therapy.
* At least 1 measurable lesion based on RECIST 1.1 that has not been previously irradiated (Part 1 exceptions permitted after review and approval)
* Able to provide pre-treatment (and optional on-treatment) tumor tissue
Exclusion Criteria
* Active or history of clinically significant autoimmune disease or other medical condition that required chronic systemic immunosuppressive therapy within recent 2 years
* Prior treatment with another LILRB1 (ILT2), LILRB2 (ILT4), and/or LILRB1/2 (B1 and B2) antagonist antibodies or pathway targeting agents, including HLA conformers and HLA-G antibodies.
* Lack of adequate organ (bone marrow, renal, liver) function
* History of severe immune-mediated adverse event or cytokine release syndrome that was considered related to prior immune modulatory therapy that required immunosuppressive therapy
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Beverly Hills Cancer Center
Beverly Hills, California, United States
Florida Cancer Specialists
Orlando, Florida, United States
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, United States
START Midwest
Grand Rapids, Michigan, United States
START San Antonio
San Antonio, Texas, United States
START Mountain Region
West Valley City, Utah, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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NCT06546553
Identifier Type: REGISTRY
Identifier Source: secondary_id
C5321001
Identifier Type: -
Identifier Source: org_study_id