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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04458259




Registration number
NCT04458259
Ethics application status
Date submitted
24/06/2020
Date registered
7/07/2020

Titles & IDs
Public title
Study of PF-07265807 in Participants With Metastatic Solid Tumors.
Scientific 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
Secondary ID [1] 0 0
ARRAY-067-102
Secondary ID [2] 0 0
C4201002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasm Metastasis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PF-07265807
Treatment: Drugs - Sasanlimab
Treatment: Drugs - Axitinib

Experimental: Monotherapy Dose Escalation: Part 1 - Monotherapy dose escalation of PF-07265807 in participants with select tumor types.

Experimental: Doublet Dose Escalation: Part 2 - 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.

Experimental: Triplet Dose Escalation: Part 3 - 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.

Experimental: Expansion Phase: Part 4, Cohort 1 - PF-07265807 monotherapy in participants with METex14 mutant NSCLC.

Experimental: Expansion Phase: Part 4, Cohort 2 - PF-07265807 with sasanlimab in participants with MSS CRC

Experimental: Expansion Phase: Part 4, Cohort 3 - PF-07265807 with sasanlimab in participants with PD-L1+ gastric cancer/GEJ

Experimental: Expansion Phase: Part 4, Cohort 4 - PF-07265807 with sasanlimab plus axitinib in participants with RCC


Treatment: Drugs: PF-07265807
Given 2 weeks on/1 week off

Treatment: Drugs: Sasanlimab
Given SC Q3W

Treatment: Drugs: Axitinib
Dosed per package label starting with 5 mg PO BID
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Parts 1, 2, and 3: Number of participants with dose limiting toxicities (DLTs)
Timepoint [1] 0 0
Baseline through day 21 or 42
Primary outcome [2] 0 0
Parts 1, 2 and 3: Number of participants with treatment emergent adverse events (AEs)
Timepoint [2] 0 0
Baseline through approximately 2 years
Primary outcome [3] 0 0
Parts 1, 2, and 3: Number of participants with laboratory abnormalities
Timepoint [3] 0 0
Baseline through approximately 2 years
Primary outcome [4] 0 0
Part 4: Overall Response Rate (ORR)
Timepoint [4] 0 0
Baseline through approximately 2 years
Primary outcome [5] 0 0
Part 4, Cohort 4: Complete Response (CR)
Timepoint [5] 0 0
Baseline through approximately 2 years
Secondary outcome [1] 0 0
Parts 1, 2, and 3: Maximum plasma concentration (Cmax) of PF-07265807 and its metabolite
Timepoint [1] 0 0
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 outcome [2] 0 0
Parts 2 and 3: Maximum plasma concentration (Cmax) of sasanlimab
Timepoint [2] 0 0
Through study completion, an average of 1 year
Secondary outcome [3] 0 0
Part 3: Maximum plasma concentration at steady state (Cmax,ss) of axitinib
Timepoint [3] 0 0
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 outcome [4] 0 0
Parts 1, 2, and 3: Time to reach maximum plasma concentration (Tmax) of PF-07265807 and its metabolite
Timepoint [4] 0 0
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 outcome [5] 0 0
Parts 2 and 3: Time to reach maximum plasma concentration (Tmax) of sasanlimab
Timepoint [5] 0 0
Through study completion, an average of 1 year
Secondary outcome [6] 0 0
Part 3: Time to reach maximum plasma concentration at steady state (Tmax,ss) of axitinib
Timepoint [6] 0 0
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 outcome [7] 0 0
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
Timepoint [7] 0 0
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 outcome [8] 0 0
Parts 2 and 3: Area under the curve from the time of dose to the last measurable concentration (AUClast) of sasanlimab
Timepoint [8] 0 0
Through study completion, an average of 1 year
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
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 outcome [10] 0 0
Part 3: Area under the curve from the time of dose to the time of the subsequent dose (AUCtau) at steady state of axitinib
Timepoint [10] 0 0
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 outcome [11] 0 0
Parts 1, 2, and 3: Terminal elimination half-life (t1/2) of PF-07265807 and its metabolite
Timepoint [11] 0 0
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 outcome [12] 0 0
Parts 2 and 3: Terminal elimination half-life (t1/2) of sasanlimab
Timepoint [12] 0 0
Through study completion, an average of 1 year
Secondary outcome [13] 0 0
Parts 1, 2, and 3: Area under the curve from the time of dose extrapolated to infinity (AUCinf) of PF-07265807 and its metabolite
Timepoint [13] 0 0
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 outcome [14] 0 0
Parts 2 and 3: Area under the curve from the time of dose extrapolated to infinity (AUCinf) of sasanlimab
Timepoint [14] 0 0
Through study completion, an average of 1 year
Secondary outcome [15] 0 0
Parts 1, 2, and 3: Apparent oral clearance (CL/F) of PF-07265807
Timepoint [15] 0 0
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 outcome [16] 0 0
Parts 2 and 3: Apparent clearance (CL/F) of sasanlimab
Timepoint [16] 0 0
Through study completion, an average of 1 year
Secondary outcome [17] 0 0
Parts 1, 2, and 3: Apparent terminal volume of distribution (Vz/F) of PF-07265807
Timepoint [17] 0 0
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 outcome [18] 0 0
Parts 2 and 3: Apparent terminal volume of distribution (Vz/F) of sasanlimab
Timepoint [18] 0 0
Through study completion, an average of 1 year
Secondary outcome [19] 0 0
Parts 1, 2, and 3: ORR
Timepoint [19] 0 0
Baseline through approximately 2 years
Secondary outcome [20] 0 0
Part 4: Number of participants with treatment emergent AEs
Timepoint [20] 0 0
Baseline through approximately 2 years
Secondary outcome [21] 0 0
Part 4: Number of participants with laboratory abnormalities
Timepoint [21] 0 0
Baseline through approximately 2 years
Secondary outcome [22] 0 0
Part 4: Trough concentration (Ctrough) of PF-07265807 and its metabolite
Timepoint [22] 0 0
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 outcome [23] 0 0
Part 4: Post dose concentration (Cmax) of PF-07265807 and its metabolite
Timepoint [23] 0 0
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 outcome [24] 0 0
Part 4, Cohorts 2, 3 and 4: Trough concentration (Ctrough) of sasanlimab
Timepoint [24] 0 0
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 outcome [25] 0 0
Part 4, Cohort 4: Trough concentration (Ctrough) of axitinib
Timepoint [25] 0 0
Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 2, and 4 hours post dose
Secondary outcome [26] 0 0
Parts 2, 3, and 4 Cohorts 2-4: Immunogenicity of sasanlimab when given in combination
Timepoint [26] 0 0
Through study completion, an average of 1 year
Secondary outcome [27] 0 0
Duration of Response
Timepoint [27] 0 0
Baseline through approximately 2 years
Secondary outcome [28] 0 0
Disease Control Rate
Timepoint [28] 0 0
Baseline through approximately 2 years
Secondary outcome [29] 0 0
Progression Free Survival
Timepoint [29] 0 0
Baseline through approximately 2 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
Accrual to date
Final
67
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
HPS Pharmacies Darlinghurst - Darlinghurst
Recruitment hospital [2] 0 0
Macquarie University - Macquarie University
Recruitment hospital [3] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [4] 0 0
Calvary Mater Newcastle - Waratah
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2109 - Macquarie University
Recruitment postcode(s) [3] 0 0
2010 - Sydney
Recruitment postcode(s) [4] 0 0
2298 - Waratah
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Canada
State/province [9] 0 0
Alberta
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
China
State/province [12] 0 0
Guangdong
Country [13] 0 0
China
State/province [13] 0 0
Jilin
Country [14] 0 0
Italy
State/province [14] 0 0
AN
Country [15] 0 0
Italy
State/province [15] 0 0
Lombardia
Country [16] 0 0
Italy
State/province [16] 0 0
Rome
Country [17] 0 0
Italy
State/province [17] 0 0
Milano
Country [18] 0 0
Italy
State/province [18] 0 0
Napoli
Country [19] 0 0
Italy
State/province [19] 0 0
Roma
Country [20] 0 0
Japan
State/province [20] 0 0
Aichi
Country [21] 0 0
Japan
State/province [21] 0 0
Chiba
Country [22] 0 0
Japan
State/province [22] 0 0
Nagoya, Aichi
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Gyeonggi-do
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Seoul-teukbyeolsi [seoul]
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Seoul
Country [26] 0 0
Spain
State/province [26] 0 0
Barcelona
Country [27] 0 0
Spain
State/province [27] 0 0
Madrid
Country [28] 0 0
Spain
State/province [28] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
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.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04458259