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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04458259
Other study ID # C4201002
Secondary ID ARRAY-067-102202
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date September 24, 2020
Est. completion date June 30, 2024

Study information

Verified date April 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 67
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 - 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. Exclusion Criteria: - 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. - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
PF-07265807
Given 2 weeks on/1 week off
Sasanlimab
Given SC Q3W
Axitinib
Dosed per package label starting with 5 mg PO BID

Locations

Country Name City State
Australia HPS Pharmacies Darlinghurst Darlinghurst New South Wales
Australia Macquarie University Macquarie University New South Wales
Australia St Vincent's Hospital Sydney New South Wales
Australia Calvary Mater Newcastle Waratah New South Wales
Canada Cross Cancer Institute Edmonton Alberta
Canada Hamilton Health Sciences-Juravinski Cancer Centre Hamilton Ontario
Canada CHU de Quebec-Universite Laval - Hotel Dieu de Quebec Québec Quebec
Canada Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus Quebec City Quebec
Canada University Health Network Toronto Ontario
China Jilin Province Tumor Hospital Changchun Jilin
China Guangdong Provincial People's Hospital Guangzhou Guangdong
Italy Azienda Ospedaliero Universitaria delle Marche Ancona AN
Italy Istituto Europeo di Oncologia IRCCS Milano
Italy Fondazione IRCCS San Gerardo dei Tintori Monza Lombardia
Italy Istituto Nazionale Tumori IRCCS Fondazione Giovanni Pascale Napoli
Italy Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore Roma
Italy Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore Roma Rome
Japan National Cancer Center Hospital East Kashiwa Chiba
Japan Aichi Cancer Center Hospital Nagoya Nagoya, Aichi
Japan Chayagasaka Eye Clinic Nagoya Aichi
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do
Korea, Republic of Seoul National University Hospital Seoul Seoul-teukbyeolsi [seoul]
Korea, Republic of Severance Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of Asan Medical Center Songpa-gu Seoul-teukbyeolsi [seoul]
Spain Hospital Universitari Vall d'Hebron Barcelona
Spain Hospital Universitario Fundacion Jimenez Díaz Madrid
Spain Hospital Universitario HM Sanchinarro Madrid
Spain Hospital Clinico Universitario de Valencia Valencia
United States Rocky Mountain Lions Eye Institute (RMLEI) Aurora Colorado
United States University of Colorado Hospital - Anschutz Cancer Pavilion (ACP) Aurora Colorado
United States University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP) Aurora Colorado
United States University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP) Aurora Colorado
United States Brigham & Women's Hospital Boston Massachusetts
United States Dana Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Duke Eye Center Durham North Carolina
United States Duke University Medical Center Durham North Carolina
United States Henry Eye Clinic Fayetteville Arkansas
United States Highlands Oncology Group Fayetteville Arkansas
United States Hackensack University Medical Center Hackensack New Jersey
United States John Theurer Cancer Center at Hackensack University Medical Center Hackensack New Jersey
United States The University of Texas M. D. Anderson Cancer Center Houston Texas
United States Community Health Network Cancer Center North Indianapolis Indiana
United States Community Health Network Investigational Drug Services Indianapolis Indiana
United States Community Health Network, Inc. Indianapolis Indiana
United States Community Health Network, Inc. Indianapolis Indiana
United States Community Health Network, Inc. Indianapolis Indiana
United States Community Health Network, Inc. Indianapolis Indiana
United States Dana-Farber Cancer Institute - Chestnut Hill Newton Massachusetts
United States UC Irvine Health Orange California
United States UC Irvine Health Orange California
United States UC Irvine Medical Center Orange California
United States UCI Chao Family Comprehensive Cancer Center Orange California
United States UCI Medical Center- Outpatient Pharmacy Orange California
United States UCI/Chao Family Comprehensive Cancer Center Orange California
United States Highlands Oncology Group Rogers Arkansas
United States Clinical & Translational Science Institute San Francisco California
United States UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California
United States UCSF Helen Diller Family Comprehensive Cancer Center - Mission Hall San Francisco California
United States UCSF Investigational Drugs Pharmacy San Francisco California
United States Highlands Oncology Group Springdale Arkansas

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Canada,  China,  Italy,  Japan,  Korea, Republic of,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) Baseline through day 21 or 42
Primary 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 Baseline through approximately 2 years
Primary Parts 1, 2, and 3: Number of participants with laboratory abnormalities Laboratory abnormalities as characterized by type, frequency, severity, and timing. Baseline through approximately 2 years
Primary Part 4: Overall Response Rate (ORR) Response will be evaluable via radiographical tumor assessment by RECIST v1.1 Baseline through approximately 2 years
Primary Part 4, Cohort 4: Complete Response (CR) Response will be evaluated via radiographical tumor assessment by RECIST v1.1 Baseline through approximately 2 years
Secondary 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 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
Secondary Parts 2 and 3: Maximum plasma concentration (Cmax) of sasanlimab Single dose (Cmax) pharmacokinetic (PK) parameters of sasanlimab Through study completion, an average of 1 year
Secondary 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 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
Secondary 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 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
Secondary Parts 2 and 3: Time to reach maximum plasma concentration (Tmax) of sasanlimab Single dose (Tmax) pharmacokinetic parameters of sasanlimab Through study completion, an average of 1 year
Secondary 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 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
Secondary 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 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
Secondary 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 Through study completion, an average of 1 year
Secondary 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 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
Secondary 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 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
Secondary 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 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
Secondary Parts 2 and 3: Terminal elimination half-life (t1/2) of sasanlimab As data permits, single dose (t1/2) pharmacokinetic parameters of sasanlimab Through study completion, an average of 1 year
Secondary 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 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
Secondary 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 Through study completion, an average of 1 year
Secondary 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 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
Secondary Parts 2 and 3: Apparent clearance (CL/F) of sasanlimab As data permits, single dose (CL/F) pharmacokinetic parameters of sasanlimab Through study completion, an average of 1 year
Secondary 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 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
Secondary Parts 2 and 3: Apparent terminal volume of distribution (Vz/F) of sasanlimab As data permits, single dose (Vz/F) pharmacokinetic parameters of sasanlimab Through study completion, an average of 1 year
Secondary Parts 1, 2, and 3: ORR Response will be evaluable via radiographical tumor assessment by RECIST v1.1 Baseline through approximately 2 years
Secondary Part 4: Number of participants with treatment emergent AEs AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy Baseline through approximately 2 years
Secondary Part 4: Number of participants with laboratory abnormalities Laboratory abnormalities as characterized by type, frequency, severity, and timing Baseline through approximately 2 years
Secondary Part 4: Trough concentration (Ctrough) of PF-07265807 and its metabolite Predose (Ctrough) pharmacokinetic (PK) parameter of PF-07265807 and its metabolite 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
Secondary Part 4: Post dose concentration (Cmax) of PF-07265807 and its metabolite Post dose (Cmax) pharmacokinetic (PK) parameter of PF-07265807 and its metabolite 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
Secondary Part 4, Cohorts 2, 3 and 4: Trough concentration (Ctrough) of sasanlimab Predose (Ctrough) pharmacokinetic (PK) parameter of sasanlimab 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
Secondary Part 4, Cohort 4: Trough concentration (Ctrough) of axitinib Predose (Ctrough) pharmacokinetic (PK) parameter of axitinib Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 2, and 4 hours post dose
Secondary Parts 2, 3, and 4 Cohorts 2-4: Immunogenicity of sasanlimab when given in combination Incidence and titer of anti-sasanlimab ADA response Through study completion, an average of 1 year
Secondary Duration of Response Response will be evaluable via radiographical tumor assessment by RECIST v1.1 Baseline through approximately 2 years
Secondary Disease Control Rate Response will be evaluable via radiographical tumor assessment by RECIST v1.1 Baseline through approximately 2 years
Secondary Progression Free Survival Response will be evaluable via radiographical tumor assessment by RECIST v1.1 Baseline through approximately 2 years
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