Non Small Cell Lung CancerPhase 1NCT06580938
A Study to Learn About PF-07921585 Alone or With Other Anti-cancer Medicines in People With Cancer
A Phase 1 study testing PF-07921585 and Sasanlimab in people with Non Small Cell Lung Cancer and Bladder Cancer, run by Pfizer at 9 sites in United States.
Trial summary
The purpose of this study is to learn about the safety and effects of the study medicine (called PF-07921585) in people with cancer that has advanced or spread to other parts of the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Bladder Cancer, Renal Cell Carcinoma
- What is being tested?
- PF-07921585 and Sasanlimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 9 sitesUnited States
- Study dates
- 11 Nov 2024to 14 Jul 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
- Participants aged ≥18 years or older at the time of informed consent.
- Tumor types and prior treatment requirements: Participants entering Parts 2 and 3 must have at least 1 measurable lesion.
- Part 1 and Part 2:
- Eligible advanced/metastatic tumor types include NSCLC, urothelial carcinoma (UC), renal cell carcinoma (RCC), melanoma, head and neck squamous cell carcinoma (HNSCC), and microsatellite stable colorectal cancer (MSS-CRC). Participants must have demonstrated radiographic progression on standard treatment(s) for their cancer
- Part 3:
- Cohort 1: Participants with metastatic melanoma with resistance to checkpoint inhibitor therapy and BRAF/MEKi.
Show all 9Show fewer
- Cohort 2: Participants with metastatic MSS-CRC.
- Cohort 3: Participants with previously untreated metastatic NSCLC.
- ECOG PS 0 or 1.
Who cannot join
- Participants with any other active malignancy within 3 years prior to enrollment.
- Known or suspected hypersensitivity to, or severe allergic history of, human albumin or anti-PD-(L)1 therapy.
- History of Grade ≥3 immune-related AE (irAE) or unresolved irAEs prior to first dose of study intervention. Exception: vitiligo and endocrinopathy that is controlled with hormonal therapy.
- History of venous thromboembolic event <12 weeks prior to starting study treatment.
- Active or history of clinically significant gastrointestinal (GI) disease.
- Active or history of interstitial lung disease or Grade ≥2 pneumonitis.
Show all 10Show fewer
- Active or history of clinically significant autoimmune disease.
- Active bleeding disorder.
- Participants who have undergone treatment with any investigational IL-12 agent.
- Active, uncontrolled infections
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Presbyterian/St. Lukes Medical Center
Denver, Colorado, 80218
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
Highlands Oncology Group
Fayetteville, Arkansas, 72703
START Midwest
Grand Rapids, Michigan, 49546
Sarah Cannon Research Institute- Pharmacy
Nashville, Tennessee, 37203
SCRI Oncology Partners
Nashville, Tennessee, 37203
Highlands Oncology Group
Rogers, Arkansas, 72758
Florida Cancer Specialists Sarasota Drug Development Unit
Sarasota, Florida, 34232
Highlands Oncology Group
Springdale, Arkansas, 72762
About this study
Official title: A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI-TUMOR ACTIVITY OF PF-07921585 AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 18 YEARS OF AGE AND OLDER WITH ADVANCED SOLID TUMORS
The purpose of this study is to learn about the safety and effects of the study medicine (called PF-07921585) in people with cancer that has advanced or spread to other parts of the body.
This study is seeking participants who have any of the following cancer types:
Read more
- non-small cell lung cancer
- colorectal cancer
- bladder cancer
- melanoma (a type of skin cancer)
- kidney cancer
- head and neck cancer Participants will receive the study medicine PF-07921585 alone or in combination with another study medicine called sasanlimab at the study clinic.
PF-07921585 will be given as an infusion into a vein or as shots under the skin, once every 3 weeks. Sasanlimab will be given as shots under the skin, also once every 3 weeks.
The experiences of participants receiving the study medicine will be studied to help see if the study medicine is safe and effective. Participants may receive study medicine for up to 2 years, depending on how the cancer responds to the study treatment. Participants may continue receiving study medicine after 2 years if there are any benefits from the study treatment. Participants will attend visits once every 3 weeks with the first 9 weeks having more frequent visits, to check the safety of the study treatment.
Read the detailed description
The study contains 3 parts:
Part 1: dose escalation of PF-07921585 as single agent to determine the monotherapy recommended dose for further study.
Part 2: dose escalation of PF-07921585 in combination with the anti-PD 1 inhibitor sasanlimab and potentially other anti-cancer agents, in order to determine the recommended dose for expansion of the combination.
Part 3: dose optimization/ expansion will evaluate PF-07921585 in combination with sasanlimab, and potentially other anti-cancer agents. After identification of the recommended dose for expansion in Part 2, participants with select solid tumors will be enrolled into 3-4 cohorts as follows:
- Cohort 1: Melanoma
- Cohort 2: Microsatellite stable (MSS) metastatic colorectal cancer
- Cohort 3: Non-small cell lung cancer (NSCLC)
- Cohort 4: Solid tumor, tumor types and clinical setting to be determined based on emerging data.
- Conditions
- Non Small Cell Lung Cancer, Bladder Cancer, Renal Cell Carcinoma, Melanoma, Head and Neck Cancer, Colorectal Cancer
- Being tested
- PF-07921585, Sasanlimab
- Keywords
- Interleukin-12 mutein, Sasanlimab, anti-PD1 antibody, lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Urinary Bladder Neoplasms, Carcinoma, Renal Cell, Melanoma, Head and Neck Neoplasms, Colorectal Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-07921585Biological
IL-12 mutein, solution, administered once every 3 weeks intravenously or subcutaneously
SasanlimabBiological
Also called PF-06801591
Anti-PD1 antibody solution, administered once every 3 weeks subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Dose escalation monotherapy Receives: Biological: PF-07921585 |
| Part 2 | Experimental | Dose escalation (combination therapy) Receives: Biological: PF-07921585; Biological: Sasanlimab |
| Part 3 | Experimental | Dose optimization/ expansion (combination therapy) Receives: Biological: PF-07921585; Biological: Sasanlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose-Limiting Toxicity (DLT) (Parts 1 and 2)
Specific adverse events occurring during the first 21 days of study medication and considered at least possibly-related to study medication
Measured: Baseline up to Cycle 2 (each cycle is 21 days)
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs (Parts 1 and 2)
AEs are any untoward medical occurrence in a participant who received study drug. Serious adverse event (SAE) are AEs 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. Treatment-emergent are events between first dose of study drug and up to 28 or 90 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Measured: Baseline up to 28 days after the last dose of PF-07921585 or after 90 days after the last dose of sasanlimab
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities (Parts 1 and 2)
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.
Measured: Baseline up to 28 days after the last dose of PF-07921585 or after 90 days after the last dose of sasanlimab
Objective Response Rate - Percentage of Participants With Objective Response (Part 3)
Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors 1. 1 (RECIST 1.1).
CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short aixs was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Measured: Date of first dose up to 2 years
Secondary outcomes (19)
Number of Participants with Treatment emergent Adverse Events (AEs) and Serious AEs (Part 3)
AEs are any untoward medical occurrence in a participant who received study drug. Serious adverse event (SAE) are AEs 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. Treatment-emergent are events between first dose of study drug and up to 28 or 90 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Measured: Baseline up to 28 days after the last dose of PF-07921585 and 90 days after the last dose of sasanlimab
Objective Response Rate-Percentage of Participants with objective response (Parts 1 and 2)
Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors 1. 1 (RECIST 1.1).
CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short aixs was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Measured: Date of first dose up to 2 years
Duration of response (DOR)-Parts 1-3
Time in weeks or months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause.
Measured: Date of first dose up to 2 years
Disease control rate (DCR)-Parts 1-3
DCR is defined as the percent of participants with a confirmed complete response (CR), partial response (PR) or stable disease (SD) according to RECIST 1.1, at 6 weeks.
Measured: Date of first dose up to 2 years
Progression Free survival (PFS)-Parts 1-3
Time in weeks or months from first dose to first documentation of objective tumor progression per RECIST 1.1 or death due to any cause.
Measured: Date of first dose until disease progression or death, up to a maximum of 4 years
Overall Survival (OS)-Part 3
Time in weeks or months from the start of study treatment to date of death due to any cause.
Measured: Date of first dose until death, up to a maximum of 4 years
Pharmacokinetic Parameters: Time to Reach Maximum Observed Plasma Concentration (Tmax)-PF-07921585
Single dose PK of PF-07921585 as monotherapy (Part 1) and in combination with sansalimab (Parts 2-3) will be calculated. Additional parameters may be calculated if data permits
Measured: At specific timepoints from Cycle 1 day 1 up to 2 years
Pharmacokinetic Parameters: Time to Reach Maximum Observed Plasma Concentration (Tmax ss)-PF-07921585
Multiple dose PK of PF-07921585 as monotherapy (Part 1) and in combination with sasanlimab (Parts 2-3) will be calculated. Additional parameters may be calculated if data permits
Measured: At specific timepoints from Cycle 1 day 1 up to 2 years
Pharmacokinetic Parameters: Area under the curve (AUCt)-PF-07921585
Single dose PK of PF-07921585 as monotherapy (Part 1) and in combination with sasanlimab (Parts 2-3) will be calculated. Additional parameters may be calculated if data permits
Measured: At specific timepoints from Cycle 1 day 1 up to 2 years
Pharmacokinetic Parameters: Area under the curve (AUCt ss)-PF-07921585
Multiple dose PK of PF-07921585 as monotherapy (Part 1) and in combination with sasanlimab (Parts 2-3) will be calculated. Additional parameters may be calculated if data permits
Measured: At specific timepoints from Cycle 1 day 1 up to 2 years
Pharmacokinetic Parameters: Cmax (maximum drug concentration in the body)-PF-07921585
Single dose PK of PF-07921585 as monotherapy will be calculated. Additional parameters may be calculated if data permits
Measured: At specific timepoints from Cycle 1 day 1 up to 2 years
Pharmacokinetic Parameters: Cmax ss (maximum drug concentration in the body)-PF-07921585
Multiple dose PK of PF-07921585 as monotherapy (Part 1) and in combination with sasanlimab (Parts 2-3) will be calculated. Additional parameters may be calculated if data permits
Measured: At specific timepoints from Cycle 1 day 1 up to 2 years
Percentage of Participants With Positive PF-07921585 Anti-Drug Antibody (ADA)
Percentage of ADA positive participants by dose level (Parts 1-3)
Measured: At specific timepoints from Cycle 1 day 1 up to 2 years
Percentage of Participants With Positive PF-07921585 neutralizing antibodies (Nab)
Percentage of Nab positive participants by dose level (Parts 1-3)
Measured: At specific timepoints from Cycle 1 Day 1 up to 2 years
Incidence and titer of PF-07921585 ADA and Nab
Parts 1-3
Measured: At specific timepoints from Cycle 1 Day 1 up to 2 years
Pharmacokinetic Parameters: C through-Sasanlimab
PK of sasanlimab (Parts 2 and 3)
Measured: At specific timepoints, predose, from Cycle 1 day 1 up to 2 years
Percentage of Participants With Positive sasanlimab Anti-Drug Antibody (ADA)
Percentage of ADA positive participants by dose level (Parts 2-3)
Measured: At specific timepoints from Cycle 1 day 1 up to 2 years
Percentage of Participants With Positive sasanlimab neutralizing antibodies (Nab)
Percentage of Nab positive participants by dose level (Parts 2-3)
Measured: At specific timepoints from Cycle 1 Day 1 up to 2 years
Incidence and titer of sasanlimab ADA and Nab
Parts 2-3
Measured: At specific timepoints from Cycle 1 Day 1 up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start11 Nov 2024
- Primary completion14 Jul 2025
- Study completion14 Jul 2025
Why it stopped: The trial was terminated for strategic reasons. The decision was not based on any safety and/or efficacy concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580938
- Sponsor's protocol ID
- C5461001
- Other IDs
- NCT06580938
- Status last verified
- Mar 2026
- First submitted
- 5 Aug 2024
- Last updated
- 23 Mar 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI-TUMOR ACTIVITY OF PF-07921585 AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 18 YEARS OF AGE AND OLDER WITH ADVANCED SOLID TUMORS
- ClinicalTrials.gov ID
- NCT06580938
- Acronym / sponsor ID
- C5461001
- Conditions
- Non Small Cell Lung Cancer, Bladder Cancer, Renal Cell Carcinoma, Melanoma, Head and Neck Cancer, Colorectal Cancer
- Keywords
- Interleukin-12 mutein, Sasanlimab, anti-PD1 antibody, lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was terminated for strategic reasons. The decision was not based on any safety and/or efficacy concerns
- Enrolment
- 4 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 14 Jul 2025 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn about the safety and effects of the study medicine (called PF-07921585) in people with cancer that has advanced or spread to other parts of the body.
This study is seeking participants who have any of the following cancer types:
- non-small cell lung cancer
- colorectal cancer
- bladder cancer
- melanoma (a type of skin cancer)
- kidney cancer
- head and neck cancer Participants will receive the study medicine PF-07921585 alone or in combination with another study medicine called sasanlimab at the study clinic.
PF-07921585 will be given as an infusion into a vein or as shots under the skin, once every 3 weeks. Sasanlimab will be given as shots under the skin, also once every 3 weeks.
The experiences of participants receiving the study medicine will be studied to help see if the study medicine is safe and effective. Participants may receive study medicine for up to 2 years, depending on how the cancer responds to the study treatment. Participants may continue receiving study medicine after 2 years if there are any benefits from the study treatment. Participants will attend visits once every 3 weeks with the first 9 weeks having more frequent visits, to check the safety of the study treatment.
Detailed description
The study contains 3 parts:
Part 1: dose escalation of PF-07921585 as single agent to determine the monotherapy recommended dose for further study.
Part 2: dose escalation of PF-07921585 in combination with the anti-PD 1 inhibitor sasanlimab and potentially other anti-cancer agents, in order to determine the recommended dose for expansion of the combination.
Part 3: dose optimization/ expansion will evaluate PF-07921585 in combination with sasanlimab, and potentially other anti-cancer agents. After identification of the recommended dose for expansion in Part 2, participants with select solid tumors will be enrolled into 3-4 cohorts as follows:
- Cohort 1: Melanoma
- Cohort 2: Microsatellite stable (MSS) metastatic colorectal cancer
- Cohort 3: Non-small cell lung cancer (NSCLC)
- Cohort 4: Solid tumor, tumor types and clinical setting to be determined based on emerging data.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Biological: PF-07921585Dose escalation monotherapy |
| Part 2 | Experimental | Biological: PF-07921585, Biological: SasanlimabDose escalation (combination therapy) |
| Part 3 | Experimental | Biological: PF-07921585, Biological: SasanlimabDose optimization/ expansion (combination therapy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants aged ≥18 years or older at the time of informed consent.
- Tumor types and prior treatment requirements: Participants entering Parts 2 and 3 must have at least 1 measurable lesion.
- Eligible advanced/metastatic tumor types include NSCLC, urothelial carcinoma (UC), renal cell carcinoma (RCC), melanoma, head and neck squamous cell carcinoma (HNSCC), and microsatellite stable colorectal cancer (MSS-CRC). Participants must have demonstrated radiographic progression on standard treatment(s) for their cancer
- ECOG PS 0 or 1.
Key exclusion criteria (10 listed)
- Participants with any other active malignancy within 3 years prior to enrollment.
- Known or suspected hypersensitivity to, or severe allergic history of, human albumin or anti-PD-(L)1 therapy.
- History of Grade ≥3 immune-related AE (irAE) or unresolved irAEs prior to first dose of study intervention. Exception: vitiligo and endocrinopathy that is controlled with hormonal therapy.
- History of venous thromboembolic event <12 weeks prior to starting study treatment.
- Active or history of clinically significant gastrointestinal (GI) disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-07921585IL-12 mutein, solution, administered once every 3 weeks intravenously or subcutaneously | Biological | Part 1, Part 2, Part 3 |
| SasanlimabAlso: PF-06801591Anti-PD1 antibody solution, administered once every 3 weeks subcutaneously | Biological | Part 2, Part 3 |
Primary outcome
Number of Participants With Dose-Limiting Toxicity (DLT) (Parts 1 and 2)
Time frame: Baseline up to Cycle 2 (each cycle is 21 days)
Specific adverse events occurring during the first 21 days of study medication and considered at least possibly-related to study medication
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs (Parts 1 and 2)
Time frame: Baseline up to 28 days after the last dose of PF-07921585 or after 90 days after the last dose of sasanlimab
AEs are any untoward medical occurrence in a participant who received study drug. Serious adverse event (SAE) are AEs 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. Treatment-emergent are events between first dose of study drug and up to 28 or 90 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities (Parts 1 and 2)
Time frame: Baseline up to 28 days after the last dose of PF-07921585 or after 90 days after the last dose of sasanlimab
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.
Objective Response Rate - Percentage of Participants With Objective Response (Part 3)
Time frame: Date of first dose up to 2 years
Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors 1. 1 (RECIST 1.1). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short aixs was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
19 secondary outcomes
Number of Participants with Treatment emergent Adverse Events (AEs) and Serious AEs (Part 3)
Time frame: Baseline up to 28 days after the last dose of PF-07921585 and 90 days after the last dose of sasanlimab
Objective Response Rate-Percentage of Participants with objective response (Parts 1 and 2)
Time frame: Date of first dose up to 2 years
Duration of response (DOR)-Parts 1-3
Time frame: Date of first dose up to 2 years
Disease control rate (DCR)-Parts 1-3
Time frame: Date of first dose up to 2 years
Progression Free survival (PFS)-Parts 1-3
Time frame: Date of first dose until disease progression or death, up to a maximum of 4 years
Overall Survival (OS)-Part 3
Time frame: Date of first dose until death, up to a maximum of 4 years
Pharmacokinetic Parameters: Time to Reach Maximum Observed Plasma Concentration (Tmax)-PF-07921585
Time frame: At specific timepoints from Cycle 1 day 1 up to 2 years
Pharmacokinetic Parameters: Time to Reach Maximum Observed Plasma Concentration (Tmax ss)-PF-07921585
Time frame: At specific timepoints from Cycle 1 day 1 up to 2 years
Pharmacokinetic Parameters: Area under the curve (AUCt)-PF-07921585
Time frame: At specific timepoints from Cycle 1 day 1 up to 2 years
Pharmacokinetic Parameters: Area under the curve (AUCt ss)-PF-07921585
Time frame: At specific timepoints from Cycle 1 day 1 up to 2 years
Pharmacokinetic Parameters: Cmax (maximum drug concentration in the body)-PF-07921585
Time frame: At specific timepoints from Cycle 1 day 1 up to 2 years
Pharmacokinetic Parameters: Cmax ss (maximum drug concentration in the body)-PF-07921585
Time frame: At specific timepoints from Cycle 1 day 1 up to 2 years
Percentage of Participants With Positive PF-07921585 Anti-Drug Antibody (ADA)
Time frame: At specific timepoints from Cycle 1 day 1 up to 2 years
Percentage of Participants With Positive PF-07921585 neutralizing antibodies (Nab)
Time frame: At specific timepoints from Cycle 1 Day 1 up to 2 years
Incidence and titer of PF-07921585 ADA and Nab
Time frame: At specific timepoints from Cycle 1 Day 1 up to 2 years
Pharmacokinetic Parameters: C through-Sasanlimab
Time frame: At specific timepoints, predose, from Cycle 1 day 1 up to 2 years
Percentage of Participants With Positive sasanlimab Anti-Drug Antibody (ADA)
Time frame: At specific timepoints from Cycle 1 day 1 up to 2 years
Percentage of Participants With Positive sasanlimab neutralizing antibodies (Nab)
Time frame: At specific timepoints from Cycle 1 Day 1 up to 2 years
Incidence and titer of sasanlimab ADA and Nab
Time frame: At specific timepoints from Cycle 1 Day 1 up to 2 years
Results and safety
The study was stopped early (reason given: The trial was terminated for strategic reasons. The decision was not based on any safety and/or efficacy concerns). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-07921585 and Sasanlimab in people with Non Small Cell Lung Cancer and Bladder Cancer, run by Pfizer at 9 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 9 inclusion and 10 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 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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: The trial was terminated for strategic reasons. The decision was not based on any safety and/or efficacy 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?
Number of Participants With Dose-Limiting Toxicity (DLT) (Parts 1 and 2) (time frame: Baseline up to Cycle 2 (each cycle is 21 days)). 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?
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 Mar 2026; AzTrials last refreshed its copy on 31 Oct 2026.