Neoplasm Metastasis Clinical Trial
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
Verified date | April 2024 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States, Australia, Canada, China, Italy, Japan, Korea, Republic of, Spain,
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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