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.

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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.

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Histological or cytological diagnosis of advanced, unresectable, and/or metastatic or relapsed/refractory solid tumor.

- 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:

- Treatment with any systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to planned first dose.

- 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06546553
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Pfizer
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Pfizer CT.gov Call Center
Principal Investigator Affiliation	Pfizer
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Active, not recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Neoplasms, Non-small-cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck, Renal Cell Carcinoma, Colorectal Carcinoma, Ovarian Carcinoma
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Part 1A: PF-07826390 Monotherapy

PF-07826390 monotherapy at prescribed dose and frequency in 28-day cycles

Experimental: Part 1B: PF-07826390 + sasanlimab

PF-07826390 + sasanlimab at prescribed dose and frequency in 28-day cycles

Experimental: Part 2A (Arm 1): PF-07826390 + sasanlimab

PF-07826390 + sasanlimab dose expansion in NSCLC 2L+ at prescribed dose and frequency in 28-day cycles

Experimental: 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

Experimental: Part 2A (Arm 3): PF-07826390 + sasanlimab

PF-07826390 + sasanlimab dose expansion in RCC 2L+ at prescribed dose and frequency in 28-day cycles

Experimental: Part 2B: PF-07826390

PF-07826390 dose expansion in NSCLC 2L+ at prescribed dose and frequency in 28-day cycles

Experimental: 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

Interventions

Drug: - 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

Biological: - sasanlimab

A monoclonal antibody that blocks the interaction between PD-1 and PD-L1/L2

Other: - SOC (anti-PD-1 + platinum -based chemo)

Standard of Care (anti-PD-1 + platinum -based chemo)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Beverly Hills Cancer Center, Beverly Hills 5328041, California 5332921

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Address

Beverly Hills Cancer Center

Beverly Hills 5328041, California 5332921, 90211

Florida Cancer Specialists, Orlando 4167147, Florida 4155751

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Florida Cancer Specialists

Orlando 4167147, Florida 4155751, 32827

Orlando 4167147, Florida 4155751

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Sarah Cannon Research Institute at Florida Cancer Specialists

Orlando 4167147, Florida 4155751, 32827

START Midwest, Grand Rapids 4994358, Michigan 5001836

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START Midwest

Grand Rapids 4994358, Michigan 5001836, 49546

San Antonio 4726206, Texas 4736286

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South Texas Accelerated Research Therapeutics (START)

San Antonio 4726206, Texas 4736286, 78229

START Mountain Region, West Valley City 5784607, Utah 5549030

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START Mountain Region

West Valley City 5784607, Utah 5549030, 84119

Virginia Cancer Specialists, Fairfax 4758023, Virginia 6254928

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Virginia Cancer Specialists

Fairfax 4758023, Virginia 6254928, 22031

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