Advanced Solid TumorsPhase 1NCT05233436
PF-07265028 As Single Agent And In Combination With Sasanlimab in Advanced or Metastatic Solid Tumors
A Phase 1 study testing PF-07265028 and Sasanlimab in people with Advanced Solid Tumors and Gastric Cancer, run by Pfizer at 8 sites in 2 countries.
Trial summary
The purpose of this study is to assess the safety and effects of PF-07265028 as monotherapy and in combination with sasanlimab. The study aims to identify the maximum tolerated dose (MTD) of PF-07265028 as monotherapy; evaluate the clinical activity of monotherapy and combination; and select the recommended dose of… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Advanced Solid Tumors, Gastric Cancer, Gastroesophageal Junction Cancer
- What is being tested?
- PF-07265028 and Sasanlimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 24 Feb 2022to 16 Oct 2023
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Across all cohorts:
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Adequate hematological, kidney and liver function
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Resolved acute effects of any prior therapy
- All participants must provide archival formalin-fixed paraffin-embedded (FFPE) tumor tissue:
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- Part 1: If archival sample is older than 6 months, the participant must consent to undergo a fresh biopsy during the screening.
- Part 2 Fresh tumor biopsy during screening is required unless there is archival tissues less than 3 months old and subsequent to the last systemic anti-cancer therapy.
- Part 1A Monotherapy:
- Histologically or cytologically confirmed advanced or metastatic solid tumors which have progressed following systemic anticancer therapies, or are resistant to standard therapy or for which no standard therapy is available, or for whom standard therapy is not tolerated.
- Part 1B Combination Therapy:
- Histologically or cytologically confirmed advanced or metastatic solid tumor which have progressed following systemic anticancer therapies, including at least 1 checkpoint inhibitor.
- Part 2 Dose Expansion:
- Histologically or cytologically confirmed advanced or metastatic malignancies, including gastric/Gastroesophageal junction cancer, Head and neck squamous cell carcinoma, or urothelial cancer (non-small cell lung cancer and other solid tumors may be included) who have progressed following systemic anticancer therapies, including at least 1 checkpoint inhibitor
Who cannot join
- Participants with any other active malignancy within 3 years prior to enrollment
- Participants with active autoimmune conditions or history of autoimmune diseases that may relapse
- History of interstitial lung disease, pneumonitis (non-infectious) or uncontrolled lung diseases
- History of prior immune-related adverse events (irAEs) Grade ≥3
- Central nervous system metastases
- Significant cardiac or pulmonary conditions or events within previous 6 months
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- Active, uncontrolled bacterial, fungal, or viral infection
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of PF-07265028
- Prior administration of HPK1 inhibitor
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States6 sites
Mary Crowley Cancer Research
Dallas, Texas, 75230
START Midwest
Grand Rapids, Michigan, 49546
University of Iowa
Iowa City, Iowa, 52242
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, 78229
HonorHealth Research Institute
Scottsdale, Arizona, 85258
HonorHealth Scottsdale Shea Medical Center
Scottsdale, Arizona, 85260
Japan2 sites
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
The Cancer Institute Hospital of JFCR
Koto, Tokyo, 135-8550
About this study
Official title: A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND EXPANSION STUDY OF PF-07265028 AS A SINGLE AGENT AND IN COMBINATION WITH SASANLIMAB EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-07265028 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS
The purpose of this study is to assess the safety and effects of PF-07265028 as monotherapy and in combination with sasanlimab.
The study aims to identify the maximum tolerated dose (MTD) of PF-07265028 as monotherapy; evaluate the clinical activity of monotherapy and combination; and select the recommended dose of PF-07265028 monotherapy and in combination for potential further studies and development.
Read more
The study contains 2 parts, Dose Escalation (Part 1) to determine the recommended dose of PF-07265028 as single agent and in combination, followed by Dose Expansion (Part 2) in selected tumor types at the recommended dose.
It is expected that most participants will take part in this study for up to 1 year with six on-site visits in the first month and then at least twice every subsequent month while they are on treatment.
Read the detailed description
The purpose of this first-in-human study is to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of increasing doses of PF-07265028 as monotherapy and in combination with sasanlimab; identify the maximum tolerated dose (MTD) of PF-07265028 monotherapy; evaluate the clinical activity of monotherapy and combination; and select the recommended dose of PF-07265028 monotherapy and in combination for potential further studies and development. The study contains 2 parts, Dose Escalation (Part 1) to determine the recommended dose of PF-07265028 as single agent and in combination, followed by Dose Expansion (Part 2) in selected tumor types at the recommended dose.
- Conditions
- Advanced Solid Tumors, Gastric Cancer, Gastroesophageal Junction Cancer, Urothelial Cancer, Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinomas
- Being tested
- PF-07265028, Sasanlimab
- Keywords
- immunotherapy, advanced solid tumor, metastatic solid tumor, first in human, Gastric cancer, Gastroesophageal junction cancer, Urothelial Cancer, Non small cell lung cancer, Head and neck squamous cell carcinomas, SCCHN, NSCLC, Lung cancer, Hematopoietic progenitor kinase 1 inhibitor, HPK1 inhibitor
- Medical subject headings
- Stomach Neoplasms, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Neoplasm Metastasis, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-07265028Drug
PF-07265028 will be administered orally
SasanlimabBiological
Also called PF-06801591
Administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Part 1A Dose Escalation Monotherapy | Experimental | Participants will receive PF-07265028 at escalating dose levels. Receives: Drug: PF-07265028 |
| Part 1B Dose Escalation Combination | Experimental | Participants will receive PF-07265028 at escalating dose levels in combination with sasanlimab fixed dose Receives: Drug: PF-07265028; Biological: Sasanlimab |
| Part 2A Dose Expansion Combination (SCCHN) | Experimental | Participants with squamous cell carcinoma of the head and neck (SCCHN) will receive PF-07265028 in combination with sasanlimab at the recommended dose from Part 1B Receives: Drug: PF-07265028; Biological: Sasanlimab |
| Part 2A Dose Expansion Combination (UC) | Experimental | Participants with urothelial cancer (UC) will receive PF-07265028 in combination with sasanlimab at the recommended dose from Part 1B Receives: Drug: PF-07265028; Biological: Sasanlimab |
| Part 2A Dose Expansion Combination (Gastric/GEJ) | Experimental | Participants with gastric/gastroesophageal junction cancer (Gastric/GEJ) will receive PF-07265028 in combination with sasanlimab at the recommended dose from Part 1B Receives: Drug: PF-07265028; Biological: Sasanlimab |
| Part 2A Dose Expansion Combination (NSCLC) | Experimental | Participants with non small cell lung cancer (NSCLC) will receive PF-07265028 in combination with sasanlimab at the recommended dose from Part 1B Receives: Drug: PF-07265028; Biological: Sasanlimab |
| Part 2A Dose Expansion Combination (selected tumor types) | Experimental | Participants with selected tumor types will receive PF-07265028 in combination with sasanlimab at the recommended dose from Part 1B Receives: Drug: PF-07265028; Biological: Sasanlimab |
| Part 2B Dose Expansion Monotherapy (selected tumor types) | Experimental | Participants with selected tumor types will receive PF-07265028 single agent at the recommended dose from Part 1A. Receives: Drug: PF-07265028 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Dose-limiting toxicities (DLTs) in Dose Escalation (Part 1)
DLTs will be evaluated during Cycle 1 (a cycle is 28 days) in Part 1. The number of DLTs will be used to determine the optimal dose
Measured: Cycle 1 (28 days)
Number of participants with adverse events (AEs)
AEs characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0), timing, seriousness, and relationship to study therapy.
Measured: Baseline through up to 2 years
Number of participants with clinically significant laboratory abnormalities
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.
Measured: Baseline through up to 2 years
Objective response rate (ORR) in Dose Expansion (Part 2)
Tumor response based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: Baseline through up to 2 years or until disease progression
Secondary outcomes (13)
The pharmacokinetic profile of single and multiple doses PF-07265028 alone and in combination with sasanlimab through Cmax.
Maximum observed plasma concentration of PF-07265028 (Cmax) and Maximum observed steady state plasma concentration (Cmax, ss)
Measured: Days 1, 8, 15, 16 and 22 of Cycle 1 (each cycle is 28 days)
The pharmacokinetic profile of single and multiple doses PF-07265028 alone and in combination with sasanlimab through Tmax.
Time to maximal observed plasma concentration of PF-07265028 (Tmax) and Time to reach Maximum Observed Steady State Plasma Concentration (Tmax,ss).
Measured: Days 1, 8, 15, 16 and 22 of Cycle 1 (each cycle is 28 days)
The pharmacokinetic profile of single and multiple doses PF-07265028 alone and in combination with sasanlimab through AUC
Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) of PF-07265028 and area under the curve within one dose interval at steady state (AUCtau,ss)
Measured: Days 1, 8, 15, 16 and 22 of Cycle 1 (each cycle is 28 days)
The effect of food on the pharmacokinetic profile of PF-07265028 through Cmax.
Maximum observed plasma concentration of PF-07265028 (Cmax) under fasted and fed conditions in the subset of participants
Measured: Days 1, 8, 15, 16 and 22 of Cycle 1 (each cycle is 28 days)
The effect of food on the pharmacokinetic profile of PF-07265028 through Tmax
Time to maximal observed plasma concentration of PF-07265028 (Tmax) under fasted and fed conditions in the subset of participants
Measured: Days 1, 8, 15, 16 and 22 of Cycle 1 (each cycle is 28 days)
The effect of food on the pharmacokinetic profile of PF-07265028 through AUC
Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) of PF-07265028 under fasted and fed conditions in the subset of participants
Measured: Days 1, 8, 15, 16 and 22 of Cycle 1 (each cycle is 28 days)
The pharmacokinetic profile of sasanlimab when given in combination with PF-07265028 through Cmin
Minimum plasma concentration (Cmin) will be calculated through the measured pre-dose plasma concentration
Measured: Day 1 of cycle 1 (each cycle is 28 days), Day 1 of cycle 2, Day 1 of cycle 3, Day 1 of cycle 5 and thereafter every 6 cycles (each cycle is 28 days)
The immunogenicity of sasanlimab when given in combination with PF-07265028 through ADA and NAb
Incidence and titers of anti-drug antibodies (ADA) and neutralizing antibodies (NAb) against sasanlimab
Measured: Day 1 of cycle 1 (each cycle is 28 days), Day 1 of cycle 2, Day 1 of cycle 3, Day 1 of cycle 5 and thereafter every 6 cycles (each cycle is 28 days)
The effect of PF-07265028 alone and in combination with sasanlimab on tumor immune biomarkers modulation
Levels of intratumor T cells and PD-L1 expression in pre- and post-treatment tumor biopsies
Measured: Baseline through up to 2 years
ORR in Dose Escalation (Part 1)
Tumor response assessment based on RECIST 1.1
Measured: From baseline through disease progression or study completion (approximately 2 years)
Time to event endpoints (DOR) in Dose Expansion (Part 2)
Duration of response (DOR) as assessed using RECIST 1.1.
Measured: From baseline through disease progression or study completion (approximately 2 years)
Time to event endpoints (PFS) in Dose Expansion (Part 2)
Progression free survival (PFS) as assessed using RECIST 1.1.
Measured: From baseline through disease progression or study completion (approximately 2 years)
Time to event endpoints (OS) in Dose Expansion (Part 2)
Overall survival (OS) assessed proportion of patients alive
Measured: From baseline through disease progression or study completion (approximately 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start24 Feb 2022
- Primary completion16 Oct 2023
- Study completion16 Oct 2023
Why it stopped: Study terminated based on internal business considerations and was not based on safety reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- 21 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
- NCT05233436
- Sponsor's protocol ID
- C4731001
- Other IDs
- NCT05233436
- Status last verified
- Feb 2026
- First submitted
- 6 Jan 2022
- Last updated
- 19 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND EXPANSION STUDY OF PF-07265028 AS A SINGLE AGENT AND IN COMBINATION WITH SASANLIMAB EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-07265028 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS
- ClinicalTrials.gov ID
- NCT05233436
- Acronym / sponsor ID
- C4731001
- Conditions
- Advanced Solid Tumors, Gastric Cancer, Gastroesophageal Junction Cancer, Urothelial Cancer, Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinomas
- Keywords
- immunotherapy, advanced solid tumor, metastatic solid tumor, first in human, Gastric cancer, Gastroesophageal junction cancer, Urothelial Cancer, Non small cell lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated based on internal business considerations and was not based on safety reasons
- Enrolment
- 21 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 16 Oct 2023 (actual)
- Study completion
- 16 Oct 2023 (actual)
- First posted
- 10 Feb 2022 (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 assess the safety and effects of PF-07265028 as monotherapy and in combination with sasanlimab.
The study aims to identify the maximum tolerated dose (MTD) of PF-07265028 as monotherapy; evaluate the clinical activity of monotherapy and combination; and select the recommended dose of PF-07265028 monotherapy and in combination for potential further studies and development.
The study contains 2 parts, Dose Escalation (Part 1) to determine the recommended dose of PF-07265028 as single agent and in combination, followed by Dose Expansion (Part 2) in selected tumor types at the recommended dose.
It is expected that most participants will take part in this study for up to 1 year with six on-site visits in the first month and then at least twice every subsequent month while they are on treatment.
Detailed description
The purpose of this first-in-human study is to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of increasing doses of PF-07265028 as monotherapy and in combination with sasanlimab; identify the maximum tolerated dose (MTD) of PF-07265028 monotherapy; evaluate the clinical activity of monotherapy and combination; and select the recommended dose of PF-07265028 monotherapy and in combination for potential further studies and development. The study contains 2 parts, Dose Escalation (Part 1) to determine the recommended dose of PF-07265028 as single agent and in combination, followed by Dose Expansion (Part 2) in selected tumor types at the recommended dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part 1A Dose Escalation Monotherapy | Experimental | Drug: PF-07265028Participants will receive PF-07265028 at escalating dose levels. |
| Part 1B Dose Escalation Combination | Experimental | Drug: PF-07265028, Biological: SasanlimabParticipants will receive PF-07265028 at escalating dose levels in combination with sasanlimab fixed dose |
| Part 2A Dose Expansion Combination (SCCHN) | Experimental | Drug: PF-07265028, Biological: SasanlimabParticipants with squamous cell carcinoma of the head and neck (SCCHN) will receive PF-07265028 in combination with sasanlimab at the recommended dose from Part 1B |
| Part 2A Dose Expansion Combination (UC) | Experimental | Drug: PF-07265028, Biological: SasanlimabParticipants with urothelial cancer (UC) will receive PF-07265028 in combination with sasanlimab at the recommended dose from Part 1B |
| Part 2A Dose Expansion Combination (Gastric/GEJ) | Experimental | Drug: PF-07265028, Biological: SasanlimabParticipants with gastric/gastroesophageal junction cancer (Gastric/GEJ) will receive PF-07265028 in combination with sasanlimab at the recommended dose from Part 1B |
| Part 2A Dose Expansion Combination (NSCLC) | Experimental | Drug: PF-07265028, Biological: SasanlimabParticipants with non small cell lung cancer (NSCLC) will receive PF-07265028 in combination with sasanlimab at the recommended dose from Part 1B |
| Part 2A Dose Expansion Combination (selected tumor types) | Experimental | Drug: PF-07265028, Biological: SasanlimabParticipants with selected tumor types will receive PF-07265028 in combination with sasanlimab at the recommended dose from Part 1B |
| Part 2B Dose Expansion Monotherapy (selected tumor types) | Experimental | Drug: PF-07265028Participants with selected tumor types will receive PF-07265028 single agent at the recommended dose from Part 1A. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Adequate hematological, kidney and liver function
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Resolved acute effects of any prior therapy
- All participants must provide archival formalin-fixed paraffin-embedded (FFPE) tumor tissue:
Key exclusion criteria (9 listed)
- Participants with any other active malignancy within 3 years prior to enrollment
- Participants with active autoimmune conditions or history of autoimmune diseases that may relapse
- History of interstitial lung disease, pneumonitis (non-infectious) or uncontrolled lung diseases
- History of prior immune-related adverse events (irAEs) Grade ≥3
- Central nervous system metastases
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-07265028PF-07265028 will be administered orally | Drug | Part 1A Dose Escalation Monotherapy, Part 1B Dose Escalation Combination, Part 2A Dose Expansion Combination (Gastric/GEJ), Part 2A Dose Expansion Combination (NSCLC), Part 2A Dose Expansion Combination (SCCHN), Part 2A Dose Expansion Combination (UC), Part 2A Dose Expansion Combination (selected tumor types), Part 2B Dose Expansion Monotherapy (selected tumor types) |
| SasanlimabAlso: PF-06801591Administered subcutaneously | Biological | Part 1B Dose Escalation Combination, Part 2A Dose Expansion Combination (Gastric/GEJ), Part 2A Dose Expansion Combination (NSCLC), Part 2A Dose Expansion Combination (SCCHN), Part 2A Dose Expansion Combination (UC), Part 2A Dose Expansion Combination (selected tumor types) |
Primary outcome
Number of participants with Dose-limiting toxicities (DLTs) in Dose Escalation (Part 1)
Time frame: Cycle 1 (28 days)
DLTs will be evaluated during Cycle 1 (a cycle is 28 days) in Part 1. The number of DLTs will be used to determine the optimal dose
Number of participants with adverse events (AEs)
Time frame: Baseline through up to 2 years
AEs characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0), timing, seriousness, and relationship to study therapy.
Number of participants with clinically significant laboratory abnormalities
Time frame: Baseline through up to 2 years
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.
Objective response rate (ORR) in Dose Expansion (Part 2)
Time frame: Baseline through up to 2 years or until disease progression
Tumor response based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
13 secondary outcomes
The pharmacokinetic profile of single and multiple doses PF-07265028 alone and in combination with sasanlimab through Cmax.
Time frame: Days 1, 8, 15, 16 and 22 of Cycle 1 (each cycle is 28 days)
The pharmacokinetic profile of single and multiple doses PF-07265028 alone and in combination with sasanlimab through Tmax.
Time frame: Days 1, 8, 15, 16 and 22 of Cycle 1 (each cycle is 28 days)
The pharmacokinetic profile of single and multiple doses PF-07265028 alone and in combination with sasanlimab through AUC
Time frame: Days 1, 8, 15, 16 and 22 of Cycle 1 (each cycle is 28 days)
The effect of food on the pharmacokinetic profile of PF-07265028 through Cmax.
Time frame: Days 1, 8, 15, 16 and 22 of Cycle 1 (each cycle is 28 days)
The effect of food on the pharmacokinetic profile of PF-07265028 through Tmax
Time frame: Days 1, 8, 15, 16 and 22 of Cycle 1 (each cycle is 28 days)
The effect of food on the pharmacokinetic profile of PF-07265028 through AUC
Time frame: Days 1, 8, 15, 16 and 22 of Cycle 1 (each cycle is 28 days)
The pharmacokinetic profile of sasanlimab when given in combination with PF-07265028 through Cmin
Time frame: Day 1 of cycle 1 (each cycle is 28 days), Day 1 of cycle 2, Day 1 of cycle 3, Day 1 of cycle 5 and thereafter every 6 cycles (each cycle is 28 days)
The immunogenicity of sasanlimab when given in combination with PF-07265028 through ADA and NAb
Time frame: Day 1 of cycle 1 (each cycle is 28 days), Day 1 of cycle 2, Day 1 of cycle 3, Day 1 of cycle 5 and thereafter every 6 cycles (each cycle is 28 days)
The effect of PF-07265028 alone and in combination with sasanlimab on tumor immune biomarkers modulation
Time frame: Baseline through up to 2 years
ORR in Dose Escalation (Part 1)
Time frame: From baseline through disease progression or study completion (approximately 2 years)
Time to event endpoints (DOR) in Dose Expansion (Part 2)
Time frame: From baseline through disease progression or study completion (approximately 2 years)
Time to event endpoints (PFS) in Dose Expansion (Part 2)
Time frame: From baseline through disease progression or study completion (approximately 2 years)
Time to event endpoints (OS) in Dose Expansion (Part 2)
Time frame: From baseline through disease progression or study completion (approximately 2 years)
Results and safety
The study was stopped early (reason given: Study terminated based on internal business considerations and was not based on safety reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 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
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-07265028 and Sasanlimab in people with Advanced Solid Tumors and Gastric Cancer, run by Pfizer at 8 sites in 2 countries.
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 14 inclusion and 9 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 19 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, Japan. 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 based on internal business considerations and was not based on safety reasons). 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 toxicities (DLTs) in Dose Escalation (Part 1) (time frame: Cycle 1 (28 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 19 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.