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NeoplasmsPhase 1NCT06546553

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.

A Phase 1 study testing PF-07826390, sasanlimab and SOC (anti-PD-1 + platinum -based chemo) in people with Neoplasms and Non-small-cell Lung Cancer, run by Pfizer at 8 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PF-07826390, sasanlimab and SOC (anti-PD-1 + platinum -based chemo)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
8 sitesUnited States
Study dates
6 Sep 2024to 3 Oct 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Florida Cancer Specialists & Research Institute, LLC

    Fort Myers, Florida, 33916

  • START Midwest

    Grand Rapids, Michigan, 49546

  • Florida Cancer Specialists

    Orlando, Florida, 32827

  • Sarah Cannon Research Institute at Florida Cancer Specialists

    Orlando, Florida, 32827

  • START San Antonio

    San Antonio, Texas, 78229

  • START Mountain Region

    West Valley City, Utah, 84119

Other trials in United States

About this study

Official title: 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.
Read more

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.

Being tested
PF-07826390, sasanlimab, SOC (anti-PD-1 + platinum -based chemo)
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
Medical subject headings
Neoplasms, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Renal Cell, Colorectal Neoplasms, Ovarian Neoplasms, Neoplasm Metastasis, Kidney Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-07826390Drug

    Also called LILRB1/2

    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

  • sasanlimabBiological

    Also called PF-06801591

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

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

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

Study groups in NCT06546553
Study groupRoleWhat they receive
Part 1A: PF-07826390 MonotherapyExperimentalPF-07826390 monotherapy at prescribed dose and frequency in 28-day cycles
Receives: Drug: PF-07826390
Part 1B: PF-07826390 + sasanlimabExperimentalPF-07826390 + sasanlimab at prescribed dose and frequency in 28-day cycles
Receives: Drug: PF-07826390; Biological: sasanlimab
Part 2A (Arm 1): PF-07826390 + sasanlimabExperimentalPF-07826390 + sasanlimab dose expansion in NSCLC 2L+ at prescribed dose and frequency in 28-day cycles
Receives: Drug: PF-07826390; Biological: sasanlimab
Part 2A (Arm 2): PF-07826390 + sasanlimabExperimentalPF-07826390 + sasanlimab dose expansion in MSS CRC 2L+ at prescribed dose and frequency in 28-day cycles
Receives: Drug: PF-07826390; Biological: sasanlimab
Part 2A (Arm 3): PF-07826390 + sasanlimabExperimentalPF-07826390 + sasanlimab dose expansion in RCC 2L+ at prescribed dose and frequency in 28-day cycles
Receives: Drug: PF-07826390; Biological: sasanlimab
Part 2B: PF-07826390ExperimentalPF-07826390 dose expansion in NSCLC 2L+ at prescribed dose and frequency in 28-day cycles
Receives: Drug: PF-07826390
Part 2C: PF-07826390 + SOCExperimentalPF-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
Receives: Drug: PF-07826390; Other: SOC (anti-PD-1 + platinum -based chemo)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: First cycle, Day 1 up to Day 28

  2. 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.

    Measured: From start of the treatment and up to 90 days after last dose or start of new anticancer therapy, whichever occurred first.

  3. 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).

    Measured: From start of the treatment and up to 90 days after last dose or start of new anticancer therapy, whichever occurred first.

  4. 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.

    Measured: 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)

  1. 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

    Measured: Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion, approximately 2 years

  2. 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.

    Measured: Baseline to confirmed disease progression, up to 2 years after the last dose of study treatment

  3. 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.

    Measured: Baseline to confirmed disease progression, up to 2 years after the last dose of study treatment

  4. 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.

    Measured: 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)

  5. 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.

    Measured: 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)

  6. 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.

    Measured: 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)

  7. 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.

    Measured: 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)

  8. 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.

    Measured: 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)

  9. 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.

    Measured: 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)

  10. Part 1 and Part 2: Serum Concentrations of PF-07826390 in combination (Part 1B, 2A and 2C)

    Day 1 (all cycles) and EOT.

    Measured: Prior to dosing at Cycle 1+ Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days)

  11. Part 1 and Part 2: Incidence and titers of antidrug antibodies (ADA) against PF-07826390

    Day 1 (all cycles) and end of treatment

    Measured: Prior to dosing at Cycle 1+ Day 1 up to end of study treatment, approximately 2 years (each cycle is 28 days)

  12. Part 1 and Part 2: Paried Tumor Biopsies

    Pre-dose and C2 Day 15

    Measured: Baseline through Cycle 2 Day 15 (each cycle is 28 days)

  13. 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.

    Measured: Cycle 1 Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days)

  14. 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.

    Measured: Cycle 1 Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days)

  15. 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.

    Measured: Cycle 1 Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days)

  16. 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.

    Measured: Cycle 1 Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days)

  17. 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.

    Measured: Cycle 1 Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days)

  18. 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.

    Measured: Cycle 1 Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days)

  19. 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.

    Measured: Cycle 1 Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days)

  20. 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.

    Measured: Cycle 1 Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2024
  2. Study start6 Sep 2024
  3. Primary completion3 Oct 2025
  4. Study completion3 Oct 2025

Why it stopped: Study terminated as part of strategic considerations and not based on safety concerns.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06546553
Sponsor's protocol ID
C5321001
Other IDs
NCT06546553
Status last verified
Feb 2026
First submitted
22 Jul 2024
Last updated
23 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-07826390, sasanlimab and SOC (anti-PD-1 + platinum -based chemo) in people with Neoplasms and Non-small-cell Lung Cancer, run by Pfizer at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study terminated as part of strategic considerations and not based on safety concerns.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PART 1: Number of participants with Dose-limiting toxicities (DLT) (time frame: First cycle, Day 1 up to Day 28). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06546553.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.

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