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.

FIRST-IN-HUMAN (FIH), OPEN-LABEL, PHASE 1 DOSE ESCALATION AND EXPANSION STUDY DESIGNED TO EVALUATE THE SAFETY, TOLERABILITY, PK, PD, AND PRELIMINARY CLINICAL ACTIVITY OF PF-07826390 AS A SINGLE AGENT OR IN COMBINATION TREATMENT FOR PARTICIPANTS WITH ADVANCED SOLID TUMORS.

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.

Study Overview

• Status: Terminated
• Conditions: Neoplasms; Renal Cell Carcinoma; Non-small-cell Lung Cancer; Squamous Cell Carcinoma of the Head and Neck; Colorectal Carcinoma; Ovarian Carcinoma
• Intervention / Treatment: Biological: sasanlimab; Drug: PF-07826390; Other: SOC (anti-PD-1 + platinum -based chemo)

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90211
      • Beverly Hills Cancer Center
  • Florida
    • Fort Myers, Florida, United States, 33916
      • Florida Cancer Specialists & Research Institute, LLC
    • Orlando, Florida, United States, 32827
      • Florida Cancer Specialists
    • Orlando, Florida, United States, 32827
      • Sarah Cannon Research Institute at Florida Cancer Specialists
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • START Midwest
  • Texas
    • San Antonio, Texas, United States, 78229
      • START San Antonio
  • Utah
    • West Valley City, Utah, United States, 84119
      • START Mountain Region
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1A: PF-07826390 Monotherapy; PF-07826390 monotherapy at prescribed dose and frequency in 28-day cycles	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; Other Names: LILRB1/2
Experimental: Part 1B: PF-07826390 + sasanlimab; PF-07826390 + sasanlimab at prescribed dose and frequency in 28-day cycles	Biological: sasanlimab; A monoclonal antibody that blocks the interaction between PD-1 and PD-L1/L2; Other Names: PF-06801591; 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; Other Names: LILRB1/2
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	Biological: sasanlimab; A monoclonal antibody that blocks the interaction between PD-1 and PD-L1/L2; Other Names: PF-06801591; 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; Other Names: LILRB1/2
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	Biological: sasanlimab; A monoclonal antibody that blocks the interaction between PD-1 and PD-L1/L2; Other Names: PF-06801591; 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; Other Names: LILRB1/2
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	Biological: sasanlimab; A monoclonal antibody that blocks the interaction between PD-1 and PD-L1/L2; Other Names: PF-06801591; 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; Other Names: LILRB1/2
Experimental: Part 2B: PF-07826390; PF-07826390 dose expansion in NSCLC 2L+ at prescribed dose and frequency in 28-day cycles	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; Other Names: LILRB1/2
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	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; Other Names: LILRB1/2; Other: SOC (anti-PD-1 + platinum -based chemo); Standard of Care (anti-PD-1 + platinum -based chemo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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
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
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)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2024
• Primary Completion (Actual): October 3, 2025
• Study Completion (Actual): October 3, 2025

Study Registration Dates

• First Submitted: July 22, 2024
• First Submitted That Met QC Criteria: August 6, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Non-Small Cell Lung Cancer; Solid tumors; Colorectal Cancer; metastatic; Kidney Neoplasms; advanced; Colorectal Carcinoma; Colorectal Neoplasms; anti-PD-1; Non-Small Cell Lung Carcinoma; Malignant Melanoma; Renal Cell Carcinoma; Colorectal Tumors; Neoplasms, Colorectal; Non-Small-Cell Lung Carcinoma; Nonsmall Cell Lung Cancer; Carcinoma, Non-Small Cell Lung; sasanlimab; PD-1 resistance; micro satellite stable; PD-1 naive; PDx resistance; PDxnaive; Microsatellite Stable Colorectal Cancer (MSS CRC); PF-07282690; LILRB12; Rectal Disease
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Pathologic Processes; Urogenital Neoplasms; Neoplasms by Site; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Intestinal Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Genital Diseases, Female; Lung Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Respiratory Tract Neoplasms; Thoracic Neoplasms; Colonic Diseases; Neoplastic Processes; Lung Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Skin Diseases; Urologic Neoplasms; Carcinoma; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Carcinoma, Squamous Cell; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Squamous Cell Carcinoma of Head and Neck; Neoplasms; Colorectal Neoplasms; Ovarian Neoplasms; Neoplasm Metastasis; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Melanoma; Kidney Neoplasms; Rectal Diseases; Amino Acids, Peptides, and Proteins; Proteins; Receptors, Cell Surface; Membrane Proteins; Receptors, Immunologic; Leukocyte Immunoglobulin-like Receptor B1
• Other Study ID Numbers: C5321001; NCT06546553 (Registry Identifier: ClinicalTrials.gov)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No