Gastrointestinal TumorsPhase 1NCT04171141

Study to Test the Safety and Tolerability of PF-07062119 in Patients With Selected Advanced or Metastatic Gastrointestinal Tumors.

A Phase 1 study testing PF-07062119, Anti-PD1 and Anti-VEGF in people with Gastrointestinal Tumors and Colorectal Adenocarcinomas, run by Pfizer at 19 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

A phase 1, open-label, dose escalation and expansion study of PF-07062119 in patients with selected advanced or metastatic gastrointestinal tumors Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Gastrointestinal Tumors, Colorectal Adenocarcinomas, Gastric Adenocarcinomas
What is being tested?: PF-07062119, Anti-PD1 and Anti-VEGF
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 79 participants
Where: 19 sitesin 3 countries
Study dates: 19 Nov 2019to 28 Nov 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

For Part 1 and Part 2, diagnosis of advanced/metastatic colorectal, gastric or esophageal adenocarcinoma that is resistant to standard therapy or for which no local regulatory approved standard therapy is available that would confer significant benefit.
For Part 2, diagnosis of colorectal adenocarcinoma that is resistant to standard therapy or for which no standard therapy is available
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
Measurable disease or non-measurable disease and refractory to or intolerant of existing therapies (Part 1)
Measurable disease as defined by RECIST 1.1 is required (Part 2)

Who cannot join

Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases
Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
Major surgery or radiation within 3 weeks prior to study entry
Last anti-cancer treatment within 4 weeks prior to study entry
Active or history of clinically significant autoimmune disease that required systemic immunosuppressive medication
Active or history of clinically significant gastrointestinal disease
Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry
Pregnant or breastfeeding female patients

Trial locations and contacts

19 sites in 3 countries.

Country

City, postcode or hospital

19 sites in 3 countries

United States15 sites

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
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, 91010
City of Hope IDS Pharmacy
Duarte, California, 91010
START Midwest
Grand Rapids, Michigan, 49546
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
UCLA Department of Medicine: Hematology-Oncology
Los Angeles, California, 90055
Memorial Sloan Kettering Cancer Center Rockefeller Outpatient Pavillion
New York, New York, 10022
Evelyn H. Lauder Breast and Imaging Center
New York, New York, 10065
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, 10065
Christus Santa Rosa Hospital
San Antonio, Texas, 78229
NEXT Oncology
San Antonio, Texas, 78229
UCLA Hematology Oncology - Santa Monica
Santa Monica, California, 90404

Other trials in United States

Australia2 sites

Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
The Royal Melbourne Hospital
Parkville, Victoria, 3050

Other trials in Australia

Japan2 sites

National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577

Other trials in Japan

About this study

Official title: A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND ANTI TUMOR ACTIVITY OF PF-07062119 IN PATIENTS WITH ADVANCED GASTROINTESTINAL TUMORS

A phase 1, open-label, dose escalation and expansion study of PF-07062119 in patients with selected advanced or metastatic gastrointestinal tumors

Read the detailed description

This is a Phase 1, open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamic study of PF-07062119 administered as a single agent in sequential dose levels and then in combination with anti-programmed cell death -1 protein (anti-PD-1) and in combination with an anti-vascular endothelial growth factor (anti-VEGF). In Part 1A, successive cohorts of patients will receive escalating doses of PF-007062119 and then in dose finding (Part 1B) with PF-07062119 in combination with anti-PD-1 and in combination with anti-VEGF. This study contains 2 parts, dose escalation with single agent (Part 1A) and then dose finding with PF-007062119 in combination with ant-PD-1 and in combination with anti-VEGF (Part 1B) followed by dose expansion arms as a single agent and PF-07062119 in combination with anti-PD 1 and in combination with anti-VEGF (Part 2).

Conditions: Gastrointestinal Tumors, Colorectal Adenocarcinomas, Gastric Adenocarcinomas, Esophageal Adenocarcinomas
Being tested: PF-07062119, Anti-PD1, Anti-VEGF
Keywords: Gastric cancer, Esophageal cancer, Colorectal cancer, Advanced esophageal cancer, Metastatic esophageal cancer, Advanced colorectal cancer, Metastatic gastric cancer, Advanced gastric cancer, Metastatic colorectal cancer, GUCY2c, Anti-PD1, Anti-VEGF, Measurable disease, PF-07062119, PF-06801591, Bevacizumab
Medical subject headings: Digestive System Neoplasms, Stomach Neoplasms, Esophageal Neoplasms, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PF-07062119Drug
PF-07062119
Anti-PD1Drug
Anti-PD1 PF-06801591
Anti-VEGFDrug
Anti-VEGF IV (bevacizumab)

Study groups in NCT04171141
Study group	Role	What they receive
Dose Escalation	Experimental	Single Agent Dose Escalation Receives: Drug: PF-07062119
Dose Finding Anti-PD-1 Combination	Experimental	Part 1B PF-07062119 plus anti-PD-1 Receives: Drug: PF-07062119; Drug: Anti-PD1
Dose Finding anti-VEGF Combination	Experimental	Part 1B PF-07062119 plus anti-VEGF Receives: Drug: PF-07062119; Drug: Anti-VEGF
Dose Expansion Arm A	Experimental	PF-07062119 as a Single Agent in CRC Receives: Drug: PF-07062119
Dose Expansion Arm B	Experimental	PF-07062119 in Combination with anti-PD-1 in CRC Receives: Drug: PF-07062119
Dose Expansion Arm C	Experimental	PF-07062119 in Combination with anti-VEGF in CRC Receives: Drug: PF-07062119; Drug: Anti-PD1; Drug: Anti-VEGF
Dose Expansion Arm D	Experimental	PF-07062119 in Combination with either anti-PD-1 or anti-VEGF in various Tumor Types Receives: Drug: PF-07062119; Drug: Anti-PD1; Drug: Anti-VEGF

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) Assessed Through Cycle 1
Hematological DLTs:
- Grade 3 neutropenia lasting >5 days
- Febrile neutropenia defined as an ANC <1.0 x 10 ̂9/L with a single temperature of >38.3°C, or a sustained temperature of ≥38°C, for more than 1 hour
- Grade ≥3 Neutropenia with infection
- Grade 3 Thrombocytopenia with Grade ≥2 (clinically significant) bleeding
- any Grade 4 Thrombocytopenia
- Anemia or Thrombocytopenia requiring transfusion
Non Hematological DLTs:
- Grade ≥3 fatigue lasting ≥7 days
- for participants with liver, bone, or lung metastasis, an AST or ALT increase >8 x ULN or ALP >10 x ULN;
- confirmed DILI meeting Hy's law criteria
- Grade 3 Vomiting or Diarrhea lasting ≥3 days despite adequate treatment/other supportive care
- Grade 4 Vomiting or Diarrhea
- Grade ≥3 CRS regardless of duration
- Grade ≥3 QTcF prolongation irrespective of duration
- any death not clearly due to underlying disease or extraneous causes Clinically important/persistent toxicities were DLTs reviewed by investigators and sponsor.
Measured: 28 Days
Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect, etc. Treatment-emergent events were with onset date occurring during the on-treatment period. AEs were documented and recorded at each visit using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Measured: 4 Years
Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect, etc. Treatment-emergent events were with onset date occurring during the on-treatment period. Relatedness to study treatment was determined by the investigator. AEs were documented and recorded at each visit using the NCI CTCAE version 5.0. Severe AEs were classified as Grade 3; life-threatening consequences and urgent intervention indicated were classified as Grade 4; deaths related to AEs were classified as Grade 5.
Measured: 4 Years
Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities
The investigator reviewed the laboratory report, documented this review, and recorded any clinically relevant changes occurring during the study in the AE section of the CRF. Clinically significant abnormal laboratory findings were those which were not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. CTCAE version 5.0 was applied.
Measured: 4 Years
Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities
The investigator reviewed the laboratory report, documented this review, and recorded any clinically relevant changes occurring during the study in the AE section of the case report form (CRF). Clinically significant abnormal laboratory findings were those which were not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. CTCAE version 5.0 was applied.
Measured: 4 Years

Secondary outcomes (15)

Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts
Cmax was observed directly from data.
Measured: Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 4 Day 1
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Cmax - Non-Priming Cohorts
Cmax was observed directly from data.
Measured: Cycle 1 Day 1 and Cycle 4 Day 1
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts
Tmax was time at which Cmax occurred which was observed directly from data as time of first occurrence.
Measured: Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 4 Day 1
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Tmax - Non-Priming Cohorts
Tmax was time at which Cmax occurred which was observed directly from data as time of first occurrence.
Measured: Cycle 1 Day 1 and Cycle 4 Day 1
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) - Priming Cohorts
AUCtau was area under the serum concentration-time profile from time 0 to time tau, the dosing interval, determined using linear/Log trapezoidal method.
Measured: Cycle 1 Day 1 and Cycle 4 Day 1
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUCtau - Non-Priming Cohorts
AUCtau was area under the serum concentration-time profile from time 0 to time tau, the dosing interval, determined using linear/Log trapezoidal method.
Measured: Cycle 1 Day 1 and Cycle 4 Day 1
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Day 1 to Day 7 (168 Hours) (AUC168) - Priming Cohorts
AUC168 was area under the serum concentration-time profile from Day 1 to Day 7 (168 hours) determined using linear/Log trapezoidal method.
Measured: Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 4 Day 1
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUC168 - Non-Priming Cohorts
AUC168 was area under the serum concentration-time profile from Day 1 to Day 7 (168 hours) determined using linear/Log trapezoidal method.
Measured: Cycle 1 Day 1 and Cycle 4 Day 1
Pre-dose Trough Concentrations After Multiple Doses of PF-07062119
PF-07062119 pre-dose trough concentrations were the serum PF-07062119 concentrations assessed at 0 min of Day 1 and Day 15 in each Cycle.
Measured: Cycle 1 Day 15, Cycle 2 Days 1 and 15, Cycle 3 Days 1 and 15, Cycle 4 Days 1 and 15, Cycle 5 Day 1, Cycle 8 Day 1 and Cycle 11 Day 1
Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119
Blood samples of approximately 4 mL, to provide a minimum of serum 2 mL, were collected for determination of ADA against PF-07062119. All samples were collected on Day 1 of a cycle (also on Day 15, in Cycle 1 only) and drawn pre-dose - within 6 hours prior to any of the drugs being administered. Starting at Cycle 5, blood samples for ADA against PF-07062119 were collected every 3rd cycle pre-dose (ie, Cycle 5 Day 1, Cycle 8 Day 1, Cycle 11 Day 1, etc.). Participants with an unresolved AE possibly related to ADA were asked to return to the clinic for ADA and drug concentration assessments at approximately 3 month intervals until the AE or its sequelae resolved or stabilized at a level acceptable to the investigator and sponsor up to a maximum of 9 months.
Measured: Pre-dose on Cycle 1 Day 1 and Day 15; Day 1 of Cycles 2 to 4; Day 1 of every 3rd cycle since Cycle 5
Titers of ADA Against PF-07062119
Blood samples of approximately 4 mL, to provide a minimum of serum 2 mL, were collected for determination of ADA against PF-07062119. ADA titers of participants with positive PF-07062119 ADA (titer ≥70) are summarized.
Measured: Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and End of Treatment
Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119
Blood samples of approximately 4 mL, to provide a minimum of serum 2 mL, were collected for determination of NAb against PF-07062119. All samples were collected on Day 1 of a cycle (also on Day 15, in Cycle 1 only) and will be drawn pre-dose - within 6 hours prior to any of the drugs being administered. Starting at Cycle 5, blood samples for NAb against PF-07062119 were collected every 3rd cycle pre-dose (ie, Cycle 5 Day 1, Cycle 8 Day 1, Cycle 11 Day 1, etc). An NAb sample was defined as positive when NAb titer was ≥2.
Measured: Pre-dose on Cycle 1 Day 1 and Day 15; Day 1 of Cycles 2 to 4; Day 1 of every 3rd cycle since Cycle 5
Incidence of ADA Positive Against PF-06801591
Blood samples of approximately 4 mL, to provide a minimum of serum 2 mL, were collected for determination of ADA against PF-06801591. All samples were collected on Day 1 of a cycle (also on Day 15, in Cycle 1 only) and drawn pre-dose - within 6 hours prior to any of the drugs being administered. Starting at Cycle 5, blood samples for ADA against PF-06801591 in Part 1B were collected every 3rd cycle pre-dose (ie, Cycle 5 Day 1, Cycle 8 Day 1, Cycle 11 Day 1, etc). Participants with an unresolved AE possibly related to ADA were asked to return to the clinic for ADA and drug concentration assessments at approximately 3 month intervals until the AE or its sequelae resolved or stabilized at a level acceptable to the investigator and sponsor up to a maximum of 9 months. A participant was PF-06801591 ADA positive when ADA titer was ≥99.
Measured: Cycle 1 Day 1 and Day 15, Cycle 2 Day 1 and Day 15, Cycle 3 Day 1 and Day 15, Cycle 4 Day 15, Cycle 5 Day 15 and End of Treatment
Percent Change From Baseline in Immune Biomarkers (CD3+ and CD8+ Cells/mm2 CT+, PD-L1 Tumor Cell Membrane Staining and PD-L1 Positive Immune Cells Per Tumor Area) in Pre-treatment and On-Treatment Paired Tumor Biopsies
Tumor biospecimens from archival and/de novo biopsies were used to analyze candidate nucleic acid and protein and cellular biomarkers for their ability to inform those participants who were most likely to benefit from treatment with the study interventions. De novo tumor biopsies obtained during therapy and upon disease progression could be used to help confirm pharmacodynamic effects of treatment and investigate potential acquired mechanisms of resistance (ie, presence of but not limited to regulatory T-cells or myeloid derived suppressor cells and other immune suppressive cells or proteins).
Measured: Baseline (Baseline was defined as the time closest to, but prior to, the start of study drug administration in the first cycle), Cycle 3 Day 1
Number of Participants With Confirmed Objective Response
Tumor assessments included all known or suspected disease sites. Imaging included contrast enhanced chest, abdomen and pelvis CT or MRI scans; brain CT or MRI scan for participants with known or suspected brain metastases; bone scan and/or bone x rays for participants with known or suspected bone metastases. For participants with known CT contrast allergy, a non-contrast CT of the chest with contrast enhanced abdominal and pelvic MRI could be used. The same imaging technique used to characterize each identified and reported lesion at baseline was employed in the tumor assessments. Assessment of response used Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Objective Response was defined as complete response (CR) + partial response (PR).
Measured: Baseline up to maximum of 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Nov 201928 Nov 2023

First posted20 Nov 2019
Study start19 Nov 2019
Primary completion28 Nov 2023
Study completion28 Nov 2023

Why it stopped: Study was terminated due to strategic considerations and not due to safety.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Gastrointestinal 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: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04171141
Sponsor's protocol ID: C3861001
Other IDs: GUCY2C
Status last verified: Jan 2025
First submitted: 8 Nov 2019
Last updated: 16 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND ANTI TUMOR ACTIVITY OF PF-07062119 IN PATIENTS WITH ADVANCED GASTROINTESTINAL TUMORS
ClinicalTrials.gov ID: NCT04171141
Acronym / sponsor ID: C3861001
Conditions: Gastrointestinal Tumors, Colorectal Adenocarcinomas, Gastric Adenocarcinomas, Esophageal Adenocarcinomas
Keywords: Gastric cancer, Esophageal cancer, Colorectal cancer, Advanced esophageal cancer, Metastatic esophageal cancer, Advanced colorectal cancer, Metastatic gastric cancer, Advanced gastric cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study was terminated due to strategic considerations and not due to safety.
Enrolment: 79 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 19 Nov 2019 (actual)
Primary completion: 28 Nov 2023 (actual)
Study completion: 28 Nov 2023 (actual)
First posted: 20 Nov 2019 (actual)
Results: Posted 16 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A phase 1, open-label, dose escalation and expansion study of PF-07062119 in patients with selected advanced or metastatic gastrointestinal tumors

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 7

Arm	Type	Receives
Dose Escalation	Experimental	Drug: PF-07062119Single Agent Dose Escalation
Dose Finding Anti-PD-1 Combination	Experimental	Drug: PF-07062119, Drug: Anti-PD1Part 1B PF-07062119 plus anti-PD-1
Dose Finding anti-VEGF Combination	Experimental	Drug: PF-07062119, Drug: Anti-VEGFPart 1B PF-07062119 plus anti-VEGF
Dose Expansion Arm A	Experimental	Drug: PF-07062119PF-07062119 as a Single Agent in CRC
Dose Expansion Arm B	Experimental	Drug: PF-07062119PF-07062119 in Combination with anti-PD-1 in CRC
Dose Expansion Arm C	Experimental	Drug: PF-07062119, Drug: Anti-PD1, Drug: Anti-VEGFPF-07062119 in Combination with anti-VEGF in CRC
Dose Expansion Arm D	Experimental	Drug: PF-07062119, Drug: Anti-PD1, Drug: Anti-VEGFPF-07062119 in Combination with either anti-PD-1 or anti-VEGF in various Tumor Types

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

For Part 1 and Part 2, diagnosis of advanced/metastatic colorectal, gastric or esophageal adenocarcinoma that is resistant to standard therapy or for which no local regulatory approved standard therapy is available that would confer significant benefit.
For Part 2, diagnosis of colorectal adenocarcinoma that is resistant to standard therapy or for which no standard therapy is available
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
Measurable disease or non-measurable disease and refractory to or intolerant of existing therapies (Part 1)
Measurable disease as defined by RECIST 1.1 is required (Part 2)

Key exclusion criteria (8 listed)

Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases
Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
Major surgery or radiation within 3 weeks prior to study entry
Last anti-cancer treatment within 4 weeks prior to study entry
Active or history of clinically significant autoimmune disease that required systemic immunosuppressive medication

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-07062119PF-07062119	Drug	Dose Escalation, Dose Expansion Arm A, Dose Expansion Arm B, Dose Expansion Arm C, Dose Expansion Arm D, Dose Finding Anti-PD-1 Combination, Dose Finding anti-VEGF Combination
Anti-PD1Anti-PD1 PF-06801591	Drug	Dose Expansion Arm C, Dose Expansion Arm D, Dose Finding Anti-PD-1 Combination
Anti-VEGFAnti-VEGF IV (bevacizumab)	Drug	Dose Expansion Arm C, Dose Expansion Arm D, Dose Finding anti-VEGF Combination

Primary outcome

Number of Participants With Dose Limiting Toxicities (DLTs) Assessed Through Cycle 1
Time frame: 28 Days
Hematological DLTs: * Grade 3 neutropenia lasting >5 days * Febrile neutropenia defined as an ANC <1.0 x 10 ̂9/L with a single temperature of >38.3°C, or a sustained temperature of ≥38°C, for more than 1 hour * Grade ≥3 Neutropenia with infection * Grade 3 Thrombocytopenia with Grade ≥2 (clinically significant) bleeding * any Grade 4 Thrombocytopenia * Anemia or Thrombocytopenia requiring transfusion Non Hematological DLTs: * Grade ≥3 fatigue lasting ≥7 days * for participants with liver, bone, or lung metastasis, an AST or ALT increase >8 x ULN or ALP >10 x ULN; * confirmed DILI meeting Hy's law criteria * Grade 3 Vomiting or Diarrhea lasting ≥3 days despite adequate treatment/other supportive care * Grade 4 Vomiting or Diarrhea * Grade ≥3 CRS regardless of duration * Grade ≥3 QTcF prolongation irrespective of duration * any death not clearly due to underlying disease or extraneous causes Clinically important/persistent toxicities were DLTs reviewed by investigators and sponsor.
Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs
Time frame: 4 Years
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect, etc. Treatment-emergent events were with onset date occurring during the on-treatment period. AEs were documented and recorded at each visit using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs
Time frame: 4 Years
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect, etc. Treatment-emergent events were with onset date occurring during the on-treatment period. Relatedness to study treatment was determined by the investigator. AEs were documented and recorded at each visit using the NCI CTCAE version 5.0. Severe AEs were classified as Grade 3; life-threatening consequences and urgent intervention indicated were classified as Grade 4; deaths related to AEs were classified as Grade 5.
Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities
Time frame: 4 Years
The investigator reviewed the laboratory report, documented this review, and recorded any clinically relevant changes occurring during the study in the AE section of the CRF. Clinically significant abnormal laboratory findings were those which were not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. CTCAE version 5.0 was applied.
Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities
Time frame: 4 Years
The investigator reviewed the laboratory report, documented this review, and recorded any clinically relevant changes occurring during the study in the AE section of the case report form (CRF). Clinically significant abnormal laboratory findings were those which were not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. CTCAE version 5.0 was applied.

15 secondary outcomes

Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts
Time frame: Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 4 Day 1
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Cmax - Non-Priming Cohorts
Time frame: Cycle 1 Day 1 and Cycle 4 Day 1
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts
Time frame: Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 4 Day 1
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Tmax - Non-Priming Cohorts
Time frame: Cycle 1 Day 1 and Cycle 4 Day 1
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) - Priming Cohorts
Time frame: Cycle 1 Day 1 and Cycle 4 Day 1
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUCtau - Non-Priming Cohorts
Time frame: Cycle 1 Day 1 and Cycle 4 Day 1
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Day 1 to Day 7 (168 Hours) (AUC168) - Priming Cohorts
Time frame: Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 4 Day 1
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUC168 - Non-Priming Cohorts
Time frame: Cycle 1 Day 1 and Cycle 4 Day 1
Pre-dose Trough Concentrations After Multiple Doses of PF-07062119
Time frame: Cycle 1 Day 15, Cycle 2 Days 1 and 15, Cycle 3 Days 1 and 15, Cycle 4 Days 1 and 15, Cycle 5 Day 1, Cycle 8 Day 1 and Cycle 11 Day 1
Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119
Time frame: Pre-dose on Cycle 1 Day 1 and Day 15; Day 1 of Cycles 2 to 4; Day 1 of every 3rd cycle since Cycle 5
Titers of ADA Against PF-07062119
Time frame: Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and End of Treatment
Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119
Time frame: Pre-dose on Cycle 1 Day 1 and Day 15; Day 1 of Cycles 2 to 4; Day 1 of every 3rd cycle since Cycle 5
Incidence of ADA Positive Against PF-06801591
Time frame: Cycle 1 Day 1 and Day 15, Cycle 2 Day 1 and Day 15, Cycle 3 Day 1 and Day 15, Cycle 4 Day 15, Cycle 5 Day 15 and End of Treatment
Percent Change From Baseline in Immune Biomarkers (CD3+ and CD8+ Cells/mm2 CT+, PD-L1 Tumor Cell Membrane Staining and PD-L1 Positive Immune Cells Per Tumor Area) in Pre-treatment and On-Treatment Paired Tumor Biopsies
Time frame: Baseline (Baseline was defined as the time closest to, but prior to, the start of study drug administration in the first cycle), Cycle 3 Day 1
Number of Participants With Confirmed Objective Response
Time frame: Baseline up to maximum of 4 years

Results and safety

Results posted to the registry on 16 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1A PF-07062119 45 µg	2	0
Part 1A PF-07062119 135 µg	3	0
Part 1A PF-07062119 400 µg	6	0
Part 1A PF-07062119 800 µg	9	0
Part 1A PF-07062119 1600 µg	2	0
Part 1A PF-07062119 400 µg/800 µg	10	0
Part 1A PF-07062119 400 µg/1200 µg	6	0
Part 1A PF-07062119 400 µg/1600 µg	6	0
Part 1A PF-07062119 400 µg/2100 µg	8	0
Part 1A PF-07062119 400 µg/2800 µg	4	0
Part 1A PF-07062119 400 µg/3700 µg	4	0
Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W	3	0
Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming	4	0
Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming	4	0
Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W	5	0
Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming	3	0

Primary outcome: Number of Participants With Dose Limiting Toxicities (DLTs) Assessed Through Cycle 1

Time frame: 28 Days. Count of participants. Unit: Participants

Measure	Part 1A PF-07062119 45 µg n = 2	Part 1A PF-07062119 135 µg n = 3	Part 1A PF-07062119 400 µg n = 5	Part 1A PF-07062119 800 µg n = 9	Part 1A PF-07062119 1600 µg n = 2	Part 1A PF-07062119 400 µg/800 µg n = 6	Part 1A PF-07062119 400 µg/1200 µg n = 3	Part 1A PF-07062119 400 µg/1600 µg n = 4	Part 1A PF-07062119 400 µg/2100 µg n = 7	Part 1A PF-07062119 400 µg/2800 µg n = 3	Part 1A PF-07062119 400 µg/3700 µg n = 2	Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W n = 3	Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming n = 4	Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming n = 2	Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W n = 5	Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming n = 3
Value	0	0	0	2	2	1	0	0	0	1	0	0	0	0	0	0

Population analysed: Analysis population included all enrolled participants who had at least 1 dose of study intervention and either experienced DLT or did not have major treatment deviations during the DLT observation period.

Primary outcome: Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs

Time frame: 4 Years. Count of participants. Unit: Participants

Measure	Part 1A PF-07062119 45 µg n = 2	Part 1A PF-07062119 135 µg n = 3	Part 1A PF-07062119 400 µg n = 6	Part 1A PF-07062119 800 µg n = 9	Part 1A PF-07062119 1600 µg n = 2	Part 1A PF-07062119 400 µg/800 µg n = 10	Part 1A PF-07062119 400 µg/1200 µg n = 6	Part 1A PF-07062119 400 µg/1600 µg n = 6	Part 1A PF-07062119 400 µg/2100 µg n = 8	Part 1A PF-07062119 400 µg/2800 µg n = 4	PART 1A PF-07062119 400 µg/3700 µg n = 4	Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W n = 3	Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming n = 4	Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming n = 4	Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W n = 5	Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming n = 3
Number of Participants With All-Causality TEAEs	2	3	6	9	2	10	6	6	8	4	4	3	4	4	5	3
Number of Participants With All-Causality TESAEs	0	1	2	3	1	4	4	2	4	1	2	0	0	3	2	1
Number of Participants With Maximum Grade 3 or 4 TEAEs	0	1	3	4	2

Primary outcome: Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs

Time frame: 4 Years. Count of participants. Unit: Participants

Measure	Part 1A PF-07062119 45 µg n = 2	Part 1A PF-07062119 135 µg n = 3	Part 1A PF-07062119 400 µg n = 6	Part 1A PF-07062119 800 µg n = 9	Part 1A PF-07062119 1600 µg n = 2	Part 1A PF-07062119 400 µg/800 µg n = 10	Part 1A PF-07062119 400 µg/1200 µg n = 6	Part 1A PF-07062119 400 µg/1600 µg n = 6	Part 1A PF-07062119 400 µg/2100 µg n = 8	Part 1A PF-07062119 400 µg/2800 µg n = 4	Part 1A PF-07062119 400 µg/3700 µg n = 4	Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W n = 3	Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming n = 4	Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming n = 4	Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W n = 5	Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming n = 3
Number of Participants With Treatment-Related TEAEs	2	3	6	9	2	10	6	6	8	4	4	3	4	4	5	3
Number of Participants With Treatment-Related TESAEs	0	0	0	2	1	1	2	0	3	1	1	0	0	1	1	1
Number of Participants With Treatment-Related Maximum Grade 3 or 4 TEAEs	0	0	1	3	2	5	0	3

Primary outcome: Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities

Time frame: 4 Years. Count of participants. Unit: Participants

Measure	Part 1A PF-07062119 135 µg n = 3	Part 1A PF-07062119 400 µg n = 6	Part 1A PF-07062119 800 µg n = 9	Part 1A PF-07062119 1600 µg n = 2	Part 1A PF-07062119 400 µg/800 µg n = 10	Part 1A PF-07062119 400 µg/1600 µg n = 6	Part 1A PF-07062119 400 µg/2100 µg n = 8	Part 1A PF-07062119 400 µg/3700 µg n = 4	Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming n = 4	Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W n = 5	Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming n = 3
Grade 3 Lymphocyte count decreased	1	2	1	1	3	3	1	1	1	3	0
Grade 4 Lymphocyte count decreased	0	0	1	0	1	0	0	0	0	0	0
Grade 3 Anemia	0	1	0	0	1	2	0	1	0

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 Years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1A PF-07062119 45 µg	0 of 2 (0%)	2 of 2 (100%)	2 of 2
Part 1A PF-07062119 135 µg	1 of 3 (33.3%)	3 of 3 (100%)	1 of 3
Part 1A PF-07062119 400 µg	2 of 6 (33.3%)	6 of 6 (100%)	5 of 6
Part 1A PF-07062119 800 µg	3 of 9 (33.3%)	9 of 9 (100%)	8 of 9
Part 1A PF-07062119 1600 µg	1 of 2 (50%)	2 of 2 (100%)	1 of 2
Part 1A PF-07062119 400 µg/800 µg	4 of 10 (40%)	10 of 10 (100%)	6 of 10
Part 1A PF-07062119 400 µg/1200 µg	4 of 6 (66.7%)	5 of 6 (83.3%)	3 of 6
Part 1A PF-07062119 400 µg/1600 µg	2 of 6 (33.3%)	6 of 6 (100%)	3 of 6
Part 1A PF-07062119 400 µg/2100 µg	4 of 8 (50%)	8 of 8 (100%)	1 of 8
Part 1A PF-07062119 400 µg/2800 µg	1 of 4 (25%)	4 of 4 (100%)	1 of 4
Part 1A PF-07062119 400 µg/3700 µg	2 of 4 (50%)	4 of 4 (100%)	4 of 4
Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W	0 of 3 (0%)	3 of 3 (100%)	2 of 3
Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming	0 of 4 (0%)	4 of 4 (100%)	2 of 4
Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming	3 of 4 (75%)	4 of 4 (100%)	2 of 4
Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W	2 of 5 (40%)	5 of 5 (100%)	2 of 5
Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming	1 of 3 (33.3%)	3 of 3 (100%)	1 of 3
Total	30 of 79 (38%)	78 of 79 (98.7%)	44 of 79

Limitations and caveats (from the sponsor): This study was terminated on 10 October 2023. Study termination was due to a strategic decision but not any safety concerns or requests from any regulatory authorities. This BR presents the study results of dose escalation phase (Part 1) collected by the study completion date (28-Nov-2023). Dose expansion phase (Part 2) of the study was not conducted due to the study termination.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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

19 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-07062119, Anti-PD1 and Anti-VEGF in people with Gastrointestinal Tumors and Colorectal Adenocarcinomas, run by Pfizer at 19 sites in 3 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 5 inclusion and 8 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 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Australia, 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?

Yes. Results are posted in the registry (first posted 16 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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) Assessed Through Cycle 1 (time frame: 28 Days). 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?

On the ClinicalTrials.gov record for NCT04171141.

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 16 Jan 2025.