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.

NCT06546553 | Terminated Phase 1 FDA Drug

• 2 other identifiers: C5321001NCT06546553
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Neoplasms; Non-small-cell Lung Cancer; Squamous Cell Carcinoma of the Head and Neck; Renal Cell Carcinoma; Colorectal Carcinoma; Ovarian Carcinoma

Keywords

Solid tumors; metastatic; advanced; micro satellite stable; anti-PD-1; PF-07282690; LILRB12; sasanlimab; PD-1 resistance; PD-1 naive; PDx resistance; PDxnaive; Carcinoma, Non-Small Cell Lung; Non-Small Cell Lung Cancer; Non-Small Cell Lung Carcinoma; Non-Small-Cell Lung Carcinoma; Nonsmall Cell Lung Cancer; Colorectal Cancer; Colorectal Neoplasms; Colorectal Carcinoma; Colorectal Tumors; Renal Cell Carcinoma; Kidney Neoplasms; Rectal Disease; Neoplasms, Colorectal; Malignant Melanoma; Microsatellite Stable Colorectal Cancer (MSS CRC)

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (20)

• Objective Response - Number of Participants with Objective Response

  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

  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

  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 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 Day 1, 2, 3, 8, 15 and 22; Cycle 2 Day 1 and 15; Cycle 3+ Day 1 (each cycle is 28 days)

Study Arms (7)

Part 1A: PF-07826390 Monotherapy

EXPERIMENTAL

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

Drug: PF-07826390

Part 1B: PF-07826390 + sasanlimab

EXPERIMENTAL

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

Drug: PF-07826390; Biological: sasanlimab

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

EXPERIMENTAL

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

Drug: PF-07826390; Biological: sasanlimab

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

EXPERIMENTAL

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

Drug: PF-07826390; Biological: sasanlimab

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

EXPERIMENTAL

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

Drug: PF-07826390; Biological: sasanlimab

Part 2B: PF-07826390

EXPERIMENTAL

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

Drug: PF-07826390

Part 2C: PF-07826390 + SOC

EXPERIMENTAL

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

Interventions

PF-07826390 DRUG

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

Also known as: LILRB1/2

Part 1A: PF-07826390 Monotherapy; Part 1B: PF-07826390 + sasanlimab; Part 2A (Arm 1): PF-07826390 + sasanlimab; Part 2A (Arm 2): PF-07826390 + sasanlimab; Part 2A (Arm 3): PF-07826390 + sasanlimab; Part 2B: PF-07826390; Part 2C: PF-07826390 + SOC

sasanlimab BIOLOGICAL

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

Also known as: PF-06801591

Part 1B: PF-07826390 + sasanlimab; Part 2A (Arm 1): PF-07826390 + sasanlimab; Part 2A (Arm 2): PF-07826390 + sasanlimab; Part 2A (Arm 3): PF-07826390 + sasanlimab

SOC (anti-PD-1 + platinum -based chemo) OTHER

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

Part 2C: PF-07826390 + SOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (8)

Beverly Hills Cancer Center

Beverly Hills, California, 90211, United States

Location

Florida Cancer Specialists & Research Institute, LLC

Fort Myers, Florida, 33916, United States

Location

Florida Cancer Specialists

Orlando, Florida, 32827, United States

Location

Sarah Cannon Research Institute at Florida Cancer Specialists

Orlando, Florida, 32827, United States

Location

START Midwest

Grand Rapids, Michigan, 49546, United States

Location

START San Antonio

San Antonio, Texas, 78229, United States

Location

START Mountain Region

West Valley City, Utah, 84119, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Related Links

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

MeSH Terms

Conditions

Neoplasms; Carcinoma, Non-Small-Cell Lung; Squamous Cell Carcinoma of Head and Neck; Carcinoma, Renal Cell; Colorectal Neoplasms; Ovarian Neoplasms; Neoplasm Metastasis; Kidney Neoplasms; Rectal Diseases; Melanoma

Interventions

Leukocyte Immunoglobulin-like Receptor B1

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Adenocarcinoma; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: August 9, 2024
• Study Start: September 6, 2024
• Primary Completion: October 3, 2025
• Study Completion: October 3, 2025
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)