Neoplasm MetastasisPhase 1NCT04458259
Study of PF-07265807 in Participants With Metastatic Solid Tumors.
A Phase 1 study testing PF-07265807, Sasanlimab and Axitinib in people with Neoplasm Metastasis, run by Pfizer at 33 sites in 5 countries.
Trial summary
A First-in-Human Pharmacokinetic, Safety, and Tolerability Study of PF-07265807 as Monotherapy and in Combination in Participants with Advanced or Metastatic Solid Tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Metastasis
- What is being tested?
- PF-07265807, Sasanlimab and Axitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 33 sitesin 5 countries
- Study dates
- 24 Sep 2020to 15 Nov 2024
- 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
- At least one measurable (Parts 1-4) or non-measurable lesion (Parts 1-3), not previously irradiated, as defined by RECIST 1.1
- ECOG Performance Status 0 or 1, 2 with approval
- Adequate Bone Marrow Function
- Adequate Renal Function
- Adequate Liver Function
- Resolved acute effects of any prior therapy
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- Able to provide adequate archival tumor tissue or freshly obtained tumor tissue (some participants will require mandatory pre- and on-treatment biopsy is part of the biomarker cohort).
- Life expectancy of at least 3 months.
- Part 1 and Part 2: Participants who are intolerant or resistant to standard treatment for selected solid tumors.
- Part 3: Participants with advanced/metastatic RCC with a clear cell component and progressed with no standard therapy available.
- Part 4, Cohort 1: Participants with NSCLC with METex14-skipping alteration(s) and progressed on at least 1 prior therapy.
- Part 4, Cohort 2: Participants with MSS CRC with intermediate TMB and progressed with no satisfactory alternative treatment available, but has not received prior treatment with an anti-PD-(L)1 therapy.
- Part 4, Cohort 3: Participants with metastatic gastric or GEJ adenocarcinoma that is PD-L1 positive that has progressed on at least 2 but no more than 3 prior chemotherapy regiments, but has not received prior treatment with an anti-PD-(L)1 therapy.
- Part 4, Cohort 4: Participants with metastatic RCC with a clear cell component with IMDC intermediate or poor risk that have not received any prior systemic therapy for metastatic disease.
Who cannot join
- Known active uncontrolled or symptomatic CNS metastases.
- Any other active malignancy within 2 years prior to enrollment.
- Major surgery within 6 weeks, radiation therapy within 4 weeks, systemic anti-cancer therapy within 2 week or 5 half-lives (4 weeks or 5 half-lives for antibody therapies or investigational drug(s) taken on another study) prior to study entry.
- Active or history of autoimmune disease requiring >10mg/day prednisone or other concurrent immunosuppressive therapy.
- Active, uncontrolled infection (controlled HBV, HCV, HIV/AIDS may be allowed) as defined in protocol.
- Retinal or other serious ophthalmic disorders as defined in protocol.
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- Clinically significant cardiac disease as defined in protocol.
- Uncontrolled HTN that cannot be controlled by medications.
- Inability to consume or absorb study drug.
- Known or suspected hypersensitivity to PF-07265807.
- Prohibited concomitant medications as defined in protocol.
- Active inflammatory GI disease, uncontrollable chronic diarrhea, or previous gastric resection or lap band surgery affecting absorption.
- Active bleeding disorder.
- Discontinuation of prior checkpoint inhibitor for treatment-related toxicity.
- Experienced >= G3 treatment-related irAE with prior PD-(L)1 agent.
- Prior treatment with selective AXL/MERTK inhibitors
- For participants receiving sasanlimab:
- Known history of non-infectious pneumonitis that required steroid treatment or current pneumonitis.
Trial locations and contacts
33 sites in 5 countries.
33 sites in 5 countries
United States25 sites
Rocky Mountain Lions Eye Institute (RMLEI)
Aurora, Colorado, 80045
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora, Colorado, 80045
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
Aurora, Colorado, 80045
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
Aurora, Colorado, 80045
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Duke Eye Center
Durham, North Carolina, 27705
Duke University Medical Center, lnvestigational Chemotherapy Service
Durham, North Carolina, 27710
Henry Eye Clinic
Fayetteville, Arkansas, 72703
Highlands Oncology Group
Fayetteville, Arkansas, 72703
Hackensack University Medical Center
Hackensack, New Jersey, 07601
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
Community Health Network, Inc.
Indianapolis, Indiana, 46219
Community Health Network, Inc.
Indianapolis, Indiana, 46227
Community Health Network Cancer Center North
Indianapolis, Indiana, 46250
Community Health Network, Inc.
Indianapolis, Indiana, 46250
Community Health Network, Inc.
Indianapolis, Indiana, 46256
Dana-Farber Cancer Institute - Chestnut Hill
Newton, Massachusetts, 02459
UCI Chao Family Comprehensive Cancer Center
Orange, California, 92868
Highlands Oncology Group
Rogers, Arkansas, 72758
Clinical & Translational Science Institute
San Francisco, California, 94158
UCSF Helen Diller Family Comprehensive Cancer Center - Mission Hall
San Francisco, California, 94158
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158
Highlands Oncology Group
Springdale, Arkansas, 72762
Italy3 sites
Istituto Nazionale Tumori IRCCS Fondazione Giovanni Pascale
Naples, 80131
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, ROME, 00168
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, 00168
Spain3 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Universitario Fundacion Jimenez Díaz
Madrid, 28040
Hospital Universitario HM Sanchinarro
Madrid, 28050
About this study
Official title: A PHASE 1, OPEN-LABEL, MULTI-CENTER, DOSE-FINDING, PHARMACOKINETIC, SAFETY AND TOLERABILITY STUDY OF PF 07265807 IN PARTICIPANTS WITH SELECTED ADVANCED OR METASTATIC SOLID TUMOR MALIGNANCIES
A First-in-Human Pharmacokinetic, Safety, and Tolerability Study of PF-07265807 as Monotherapy and in Combination in Participants with Advanced or Metastatic Solid Tumors
- Conditions
- Neoplasm Metastasis
- Being tested
- PF-07265807, Sasanlimab, Axitinib
- Keywords
- TAMK (TAM kinase), MER (mer proto-oncogene), MERTK (mer proto-oncogene tyrosine kinase), AXL (AXL receptor tyrosine kinase), AXL/MER, Selective kinase inhibitor, PD-1 (programmed cell death protein 1), PD-L1 (programmed cell death ligand 1), Immune modulator, Advanced Cancer, Metastatic Cancer, Solid Tumor Cancer, Metastatic Solid Tumor, Cervical Cancer, Gastric Cancer, Esophageal Cancer, Endometrial Cancer, Hepatocellular carcinoma (HCC), Melanoma, Merkel Cell Carcinoma
- Medical subject headings
- Neoplasm Metastasis, Parkinson Disease 4, Autosomal Dominant Lewy Body, Uterine Cervical Neoplasms, Stomach Neoplasms, Esophageal Neoplasms, Endometrial Neoplasms, Carcinoma, Hepatocellular, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-07265807Drug
Also called ARRY-067
Given 2 weeks on/1 week off
SasanlimabDrug
Also called PF-06801591; RN-888
Given SC Q3W
AxitinibDrug
Also called AG-013736; Inlyta
Dosed per package label starting with 5 mg PO BID
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy Dose Escalation: Part 1 | Experimental | Monotherapy dose escalation of PF-07265807 in participants with select tumor types. Receives: Drug: PF-07265807 |
| Doublet Dose Escalation: Part 2 | Experimental | Doublet combination dose escalation of PF-07265807 with sasanlimab in participants with select tumor types. PF-07265807 will dose escalate. Sasanlimab dose will stay constant. Receives: Drug: PF-07265807; Drug: Sasanlimab |
| Triplet Dose Escalation: Part 3 | Experimental | Triplet combination dose escalation of PF-07265807 with sasanlimab plus axitinib in participants with select tumor types. PF-07265807 will dose escalate. Sasanlimab dose will stay constant. Axitinib dose will follow label. Receives: Drug: PF-07265807; Drug: Sasanlimab; Drug: Axitinib |
| Expansion Phase: Part 4, Cohort 1 | Experimental | PF-07265807 monotherapy in participants with METex14 mutant NSCLC. Receives: Drug: PF-07265807 |
| Expansion Phase: Part 4, Cohort 2 | Experimental | PF-07265807 with sasanlimab in participants with MSS CRC Receives: Drug: PF-07265807; Drug: Sasanlimab |
| Expansion Phase: Part 4, Cohort 3 | Experimental | PF-07265807 with sasanlimab in participants with PD-L1+ gastric cancer/GEJ Receives: Drug: PF-07265807; Drug: Sasanlimab |
| Expansion Phase: Part 4, Cohort 4 | Experimental | PF-07265807 with sasanlimab plus axitinib in participants with RCC Receives: Drug: PF-07265807; Drug: Sasanlimab; Drug: Axitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts 1, 2, and 3: Number of participants with dose limiting toxicities (DLTs)
DLTs will be evaluated during the first cycle (day 21) or two cycles (day 42). The number of DLTs will be used to determine the maximum tolerated dose (MTD)
Measured: Baseline through day 21 or 42
Parts 1, 2 and 3: Number of participants with treatment emergent adverse events (AEs)
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
Measured: Baseline through approximately 2 years
Parts 1, 2, and 3: Number of participants with laboratory abnormalities
Laboratory abnormalities as characterized by type, frequency, severity, and timing.
Measured: Baseline through approximately 2 years
Part 4: Overall Response Rate (ORR)
Response will be evaluable via radiographical tumor assessment by RECIST v1.1
Measured: Baseline through approximately 2 years
Part 4, Cohort 4: Complete Response (CR)
Response will be evaluated via radiographical tumor assessment by RECIST v1.1
Measured: Baseline through approximately 2 years
Secondary outcomes (29)
Parts 1, 2, and 3: Maximum plasma concentration (Cmax) of PF-07265807 and its metabolite
Single dose (Cmax) and multiple dose (assuming steady state is achieved; Cmax,ss) pharmacokinetic (PK) parameters of PF-07265807 and its metabolite
Measured: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Parts 2 and 3: Maximum plasma concentration (Cmax) of sasanlimab
Single dose (Cmax) pharmacokinetic (PK) parameters of sasanlimab
Measured: Through study completion, an average of 1 year
Part 3: Maximum plasma concentration at steady state (Cmax,ss) of axitinib
Multiple dose (assuming steady state is achieved; Cmax,ss) pharmacokinetic (PK) parameters of axitinib
Measured: Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 0.5,1,2,4, and 8 hours post dose
Parts 1, 2, and 3: Time to reach maximum plasma concentration (Tmax) of PF-07265807 and its metabolite
Single dose (Tmax) and multiple dose (assuming steady state is achieved; Tmax,ss) pharmacokinetic parameters of PF-07265807 and its metabolite
Measured: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Parts 2 and 3: Time to reach maximum plasma concentration (Tmax) of sasanlimab
Single dose (Tmax) pharmacokinetic parameters of sasanlimab
Measured: Through study completion, an average of 1 year
Part 3: Time to reach maximum plasma concentration at steady state (Tmax,ss) of axitinib
Multiple dose (assuming steady state is achieved; Tmax,ss) pharmacokinetic parameters of axitinib
Measured: Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 0.5,1,2,4, and 8 hours post dose
Parts 1, 2, and 3: Area under the curve from the time of dose to the last measurable concentration (AUClast) of PF-07265807 and its metabolite
Single dose (AUClast) pharmacokinetic parameters of PF-07265807 and its metabolite
Measured: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Parts 2 and 3: Area under the curve from the time of dose to the last measurable concentration (AUClast) of sasanlimab
Single dose (AUClast) pharmacokinetic parameters of sasanlimab
Measured: Through study completion, an average of 1 year
Parts 1, 2, and 3: Area under the curve from the time of dose to the time of the subsequent dose (AUCtau) at steady state of PF-07265807 and its metabolite
Multiple dose assuming steady state is achieved (AUCtau,ss) pharmacokinetic parameters of PF-07265807 and its metabolite
Measured: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Part 3: Area under the curve from the time of dose to the time of the subsequent dose (AUCtau) at steady state of axitinib
Multiple dose assuming steady state is achieved (AUCtau,ss) pharmacokinetic parameters of axitinib
Measured: Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 0.5,1,2,4, and 8 hours post dose
Parts 1, 2, and 3: Terminal elimination half-life (t1/2) of PF-07265807 and its metabolite
As data permits, single dose (t1/2) pharmacokinetic parameters of PF-07265807 and its metabolite
Measured: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Parts 2 and 3: Terminal elimination half-life (t1/2) of sasanlimab
As data permits, single dose (t1/2) pharmacokinetic parameters of sasanlimab
Measured: Through study completion, an average of 1 year
Parts 1, 2, and 3: Area under the curve from the time of dose extrapolated to infinity (AUCinf) of PF-07265807 and its metabolite
As data permits, single dose (AUCinf) pharmacokinetic parameters of PF-07265807 and its metabolite
Measured: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Parts 2 and 3: Area under the curve from the time of dose extrapolated to infinity (AUCinf) of sasanlimab
As data permits, single dose (AUCinf) pharmacokinetic parameters of sasanlimab
Measured: Through study completion, an average of 1 year
Parts 1, 2, and 3: Apparent oral clearance (CL/F) of PF-07265807
As data permits, single dose (CL/F) and multiple dose pharmacokinetic parameters of PF-07265807
Measured: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Parts 2 and 3: Apparent clearance (CL/F) of sasanlimab
As data permits, single dose (CL/F) pharmacokinetic parameters of sasanlimab
Measured: Through study completion, an average of 1 year
Parts 1, 2, and 3: Apparent terminal volume of distribution (Vz/F) of PF-07265807
As data permits, single dose (Vz/F) and multiple dose (Vss/F) pharmacokinetic parameters of PF-07265807
Measured: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Parts 2 and 3: Apparent terminal volume of distribution (Vz/F) of sasanlimab
As data permits, single dose (Vz/F) pharmacokinetic parameters of sasanlimab
Measured: Through study completion, an average of 1 year
Parts 1, 2, and 3: ORR
Response will be evaluable via radiographical tumor assessment by RECIST v1.1
Measured: Baseline through approximately 2 years
Part 4: Number of participants with treatment emergent AEs
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
Measured: Baseline through approximately 2 years
Part 4: Number of participants with laboratory abnormalities
Laboratory abnormalities as characterized by type, frequency, severity, and timing
Measured: Baseline through approximately 2 years
Part 4: Trough concentration (Ctrough) of PF-07265807 and its metabolite
Predose (Ctrough) pharmacokinetic (PK) parameter of PF-07265807 and its metabolite
Measured: Each cycle is 21 days. Cycle 1 Days 1 and 14 predose, 2, 4 hours post dose; Cycle 1 Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14 predose
Part 4: Post dose concentration (Cmax) of PF-07265807 and its metabolite
Post dose (Cmax) pharmacokinetic (PK) parameter of PF-07265807 and its metabolite
Measured: Each cycle is 21 days. Cycle 1 Days 1 and 14 predose, 2, 4 hours post dose; Cycle 1 Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14 predose
Part 4, Cohorts 2, 3 and 4: Trough concentration (Ctrough) of sasanlimab
Predose (Ctrough) pharmacokinetic (PK) parameter of sasanlimab
Measured: Each cycle is 21 days. Cycle 1 Days 1, 7, and 14, Cycle 2 Day 1, Cycle 7 Day 1, and every 6 cycles thereafter predose
Part 4, Cohort 4: Trough concentration (Ctrough) of axitinib
Predose (Ctrough) pharmacokinetic (PK) parameter of axitinib
Measured: Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 2, and 4 hours post dose
Parts 2, 3, and 4 Cohorts 2-4: Immunogenicity of sasanlimab when given in combination
Incidence and titer of anti-sasanlimab ADA response
Measured: Through study completion, an average of 1 year
Duration of Response
Response will be evaluable via radiographical tumor assessment by RECIST v1.1
Measured: Baseline through approximately 2 years
Disease Control Rate
Response will be evaluable via radiographical tumor assessment by RECIST v1.1
Measured: Baseline through approximately 2 years
Progression Free Survival
Response will be evaluable via radiographical tumor assessment by RECIST v1.1
Measured: Baseline through 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 posted7 Jul 2020
- Study start24 Sep 2020
- Primary completion15 Nov 2024
- Study completion15 Nov 2024
Why it stopped: Pfizer has made an internal business decision to not continue further development of PF-07265807. This decision was not due to major safety concerns or requests from any regulatory authorities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm MetastasisStudies 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
- Model description
- Dose escalation and expansion
- Masking
- None (open label)
- Enrolment
- 88 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
- NCT04458259
- Sponsor's protocol ID
- C4201002
- Other IDs
- 2021-004270-59, ARRAY-067-102
- Status last verified
- Oct 2025
- First submitted
- 24 Jun 2020
- Last updated
- 4 Jun 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 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN-LABEL, MULTI-CENTER, DOSE-FINDING, PHARMACOKINETIC, SAFETY AND TOLERABILITY STUDY OF PF 07265807 IN PARTICIPANTS WITH SELECTED ADVANCED OR METASTATIC SOLID TUMOR MALIGNANCIES
- ClinicalTrials.gov ID
- NCT04458259
- Acronym / sponsor ID
- C4201002
- Conditions
- Neoplasm Metastasis
- Keywords
- TAMK (TAM kinase), MER (mer proto-oncogene), MERTK (mer proto-oncogene tyrosine kinase), AXL (AXL receptor tyrosine kinase), AXL/MER, Selective kinase inhibitor, PD-1 (programmed cell death protein 1), PD-L1 (programmed cell death ligand 1)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Pfizer has made an internal business decision to not continue further development of PF-07265807. This decision was not due to major safety concerns or requests from any regulatory authorities.
- Enrolment
- 88 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 7 Jul 2020 (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.
A First-in-Human Pharmacokinetic, Safety, and Tolerability Study of PF-07265807 as Monotherapy and in Combination in Participants with Advanced or Metastatic Solid Tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
- Model description
- Dose escalation and expansion
| Arm | Type | Receives |
|---|---|---|
| Monotherapy Dose Escalation: Part 1 | Experimental | Drug: PF-07265807Monotherapy dose escalation of PF-07265807 in participants with select tumor types. |
| Doublet Dose Escalation: Part 2 | Experimental | Drug: PF-07265807, Drug: SasanlimabDoublet combination dose escalation of PF-07265807 with sasanlimab in participants with select tumor types. PF-07265807 will dose escalate. Sasanlimab dose will stay constant. |
| Triplet Dose Escalation: Part 3 | Experimental | Drug: PF-07265807, Drug: Sasanlimab, Drug: AxitinibTriplet combination dose escalation of PF-07265807 with sasanlimab plus axitinib in participants with select tumor types. PF-07265807 will dose escalate. Sasanlimab dose will stay constant. Axitinib dose will follow label. |
| Expansion Phase: Part 4, Cohort 1 | Experimental | Drug: PF-07265807PF-07265807 monotherapy in participants with METex14 mutant NSCLC. |
| Expansion Phase: Part 4, Cohort 2 | Experimental | Drug: PF-07265807, Drug: SasanlimabPF-07265807 with sasanlimab in participants with MSS CRC |
| Expansion Phase: Part 4, Cohort 3 | Experimental | Drug: PF-07265807, Drug: SasanlimabPF-07265807 with sasanlimab in participants with PD-L1+ gastric cancer/GEJ |
| Expansion Phase: Part 4, Cohort 4 | Experimental | Drug: PF-07265807, Drug: Sasanlimab, Drug: AxitinibPF-07265807 with sasanlimab plus axitinib in participants with RCC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- At least one measurable (Parts 1-4) or non-measurable lesion (Parts 1-3), not previously irradiated, as defined by RECIST 1.1
- ECOG Performance Status 0 or 1, 2 with approval
- Adequate Bone Marrow Function
- Adequate Renal Function
- Adequate Liver Function
Key exclusion criteria (18 listed)
- Known active uncontrolled or symptomatic CNS metastases.
- Any other active malignancy within 2 years prior to enrollment.
- Major surgery within 6 weeks, radiation therapy within 4 weeks, systemic anti-cancer therapy within 2 week or 5 half-lives (4 weeks or 5 half-lives for antibody therapies or investigational drug(s) taken on another study) prior to study entry.
- Active or history of autoimmune disease requiring >10mg/day prednisone or other concurrent immunosuppressive therapy.
- Active, uncontrolled infection (controlled HBV, HCV, HIV/AIDS may be allowed) as defined in protocol.
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-07265807Also: ARRY-067Given 2 weeks on/1 week off | Drug | Doublet Dose Escalation: Part 2, Expansion Phase: Part 4, Cohort 1, Expansion Phase: Part 4, Cohort 2, Expansion Phase: Part 4, Cohort 3, Expansion Phase: Part 4, Cohort 4, Monotherapy Dose Escalation: Part 1, Triplet Dose Escalation: Part 3 |
| SasanlimabAlso: PF-06801591; RN-888Given SC Q3W | Drug | Doublet Dose Escalation: Part 2, Expansion Phase: Part 4, Cohort 2, Expansion Phase: Part 4, Cohort 3, Expansion Phase: Part 4, Cohort 4, Triplet Dose Escalation: Part 3 |
| AxitinibAlso: AG-013736; InlytaDosed per package label starting with 5 mg PO BID | Drug | Expansion Phase: Part 4, Cohort 4, Triplet Dose Escalation: Part 3 |
Primary outcome
Parts 1, 2, and 3: Number of participants with dose limiting toxicities (DLTs)
Time frame: Baseline through day 21 or 42
DLTs will be evaluated during the first cycle (day 21) or two cycles (day 42). The number of DLTs will be used to determine the maximum tolerated dose (MTD)
Parts 1, 2 and 3: Number of participants with treatment emergent adverse events (AEs)
Time frame: Baseline through approximately 2 years
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
Parts 1, 2, and 3: Number of participants with laboratory abnormalities
Time frame: Baseline through approximately 2 years
Laboratory abnormalities as characterized by type, frequency, severity, and timing.
Part 4: Overall Response Rate (ORR)
Time frame: Baseline through approximately 2 years
Response will be evaluable via radiographical tumor assessment by RECIST v1.1
Part 4, Cohort 4: Complete Response (CR)
Time frame: Baseline through approximately 2 years
Response will be evaluated via radiographical tumor assessment by RECIST v1.1
29 secondary outcomes
Parts 1, 2, and 3: Maximum plasma concentration (Cmax) of PF-07265807 and its metabolite
Time frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Parts 2 and 3: Maximum plasma concentration (Cmax) of sasanlimab
Time frame: Through study completion, an average of 1 year
Part 3: Maximum plasma concentration at steady state (Cmax,ss) of axitinib
Time frame: Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 0.5,1,2,4, and 8 hours post dose
Parts 1, 2, and 3: Time to reach maximum plasma concentration (Tmax) of PF-07265807 and its metabolite
Time frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Parts 2 and 3: Time to reach maximum plasma concentration (Tmax) of sasanlimab
Time frame: Through study completion, an average of 1 year
Part 3: Time to reach maximum plasma concentration at steady state (Tmax,ss) of axitinib
Time frame: Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 0.5,1,2,4, and 8 hours post dose
Parts 1, 2, and 3: Area under the curve from the time of dose to the last measurable concentration (AUClast) of PF-07265807 and its metabolite
Time frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Parts 2 and 3: Area under the curve from the time of dose to the last measurable concentration (AUClast) of sasanlimab
Time frame: Through study completion, an average of 1 year
Parts 1, 2, and 3: Area under the curve from the time of dose to the time of the subsequent dose (AUCtau) at steady state of PF-07265807 and its metabolite
Time frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Part 3: Area under the curve from the time of dose to the time of the subsequent dose (AUCtau) at steady state of axitinib
Time frame: Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 0.5,1,2,4, and 8 hours post dose
Parts 1, 2, and 3: Terminal elimination half-life (t1/2) of PF-07265807 and its metabolite
Time frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Parts 2 and 3: Terminal elimination half-life (t1/2) of sasanlimab
Time frame: Through study completion, an average of 1 year
Parts 1, 2, and 3: Area under the curve from the time of dose extrapolated to infinity (AUCinf) of PF-07265807 and its metabolite
Time frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Parts 2 and 3: Area under the curve from the time of dose extrapolated to infinity (AUCinf) of sasanlimab
Time frame: Through study completion, an average of 1 year
Parts 1, 2, and 3: Apparent oral clearance (CL/F) of PF-07265807
Time frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Parts 2 and 3: Apparent clearance (CL/F) of sasanlimab
Time frame: Through study completion, an average of 1 year
Parts 1, 2, and 3: Apparent terminal volume of distribution (Vz/F) of PF-07265807
Time frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Parts 2 and 3: Apparent terminal volume of distribution (Vz/F) of sasanlimab
Time frame: Through study completion, an average of 1 year
Parts 1, 2, and 3: ORR
Time frame: Baseline through approximately 2 years
Part 4: Number of participants with treatment emergent AEs
Time frame: Baseline through approximately 2 years
Part 4: Number of participants with laboratory abnormalities
Time frame: Baseline through approximately 2 years
Part 4: Trough concentration (Ctrough) of PF-07265807 and its metabolite
Time frame: Each cycle is 21 days. Cycle 1 Days 1 and 14 predose, 2, 4 hours post dose; Cycle 1 Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14 predose
Part 4: Post dose concentration (Cmax) of PF-07265807 and its metabolite
Time frame: Each cycle is 21 days. Cycle 1 Days 1 and 14 predose, 2, 4 hours post dose; Cycle 1 Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14 predose
Part 4, Cohorts 2, 3 and 4: Trough concentration (Ctrough) of sasanlimab
Time frame: Each cycle is 21 days. Cycle 1 Days 1, 7, and 14, Cycle 2 Day 1, Cycle 7 Day 1, and every 6 cycles thereafter predose
Part 4, Cohort 4: Trough concentration (Ctrough) of axitinib
Time frame: Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 2, and 4 hours post dose
Parts 2, 3, and 4 Cohorts 2-4: Immunogenicity of sasanlimab when given in combination
Time frame: Through study completion, an average of 1 year
Duration of Response
Time frame: Baseline through approximately 2 years
Disease Control Rate
Time frame: Baseline through approximately 2 years
Progression Free Survival
Time frame: Baseline through approximately 2 years
Results and safety
The study was stopped early (reason given: Pfizer has made an internal business decision to not continue further development of PF-07265807. This decision was not due to major safety concerns or requests from any regulatory authorities.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 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
33 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-07265807, Sasanlimab and Axitinib in people with Neoplasm Metastasis, run by Pfizer at 33 sites in 5 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 18 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 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Italy, Spain, Canada, 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: Pfizer has made an internal business decision to not continue further development of PF-07265807. This decision was not due to major safety concerns or requests from any regulatory authorities.). 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?
Parts 1, 2, and 3: Number of participants with dose limiting toxicities (DLTs) (time frame: Baseline through day 21 or 42). The study lists 5 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 4 Jun 2026.