Symbiotic-GI-03: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer

April 20, 2026 updated by: Pfizer

AN INTERVENTIONAL, PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH METASTATIC COLORECTAL CANCER

The purpose of this study is to learn more about a new medicine called PF-08634404, and how well it works in people with cancer of the colon or rectum (CRC)). The goal is to understand if the new study medicine, combined with chemotherapy that is approved for colorectal cancer, can help people whose cancer has spread or returned after treatments taken before.

To join the study, participants must meet the following conditions:

Be 18 years or older.
Have colorectal cancer that has spread to other parts of your body.
Be in good enough health to receive study treatment.
Should not be pregnant before starting treatment.

Participants will be randomized (like flipping a coin) to one of 2 different treatment arms. The first arm (Arm A) will include the new medicine PF-08634404 in combination with chemotherapy that is approved for colorectal cancer, and the second arm (Arm B) will include an approved medicine for colorectal cancer, called Bevacizumab, in combination with chemotherapy that is approved for this type of cancer. Participants and their doctors will not know which arm they are being assigned to. Participants will receive all the study medications through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, and participants may continue receiving it if it is helping and they are not experiencing serious side effects.

The medicine will be given at a clinical site, where trained medical staff will check participants during and after each treatment.

The study is expected to last approximately 33 months for each participant.
Participants will have regular visits to the study site for treatment, health checks, and tests.
After stopping treatment, participants will return for a final visit about 30 to37 days later to check their health and review any side effects.
Follow-up will continue every 12 weeks by phone or in person or by reviewing health records to check on health status and any new treatments.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

800

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Pfizer CT.gov Call Center
Phone Number: 1-800-718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

Australia
- Queensland
  - Auchenflower, Queensland, Australia, 4066
    - Recruiting
    - Icon Cancer Centre Wesley
- Tasmania
  - Hobart, Tasmania, Australia, 7000
    - Recruiting
    - Icon Cancer Centre Hobart
- Victoria
  - Melbourne, Victoria, Australia, 3000
    - Recruiting
    - Peter MacCallum Cancer Centre
Belgium
- - Ghent, Belgium, 9000
    - Not yet recruiting
    - AZ Sint-Lucas
- Hainaut
  - Charleroi, Hainaut, Belgium, 6060
    - Not yet recruiting
    - Grand Hopital de Charleroi
Brazil
- São Paulo
  - São Caetano do Sul, São Paulo, Brazil, 09541-270
    - Recruiting
    - Centro de Oncologia - CEON+ - Unidade São Caetano do Sul
Canada
- Ontario
  - Toronto, Ontario, Canada, M5G 2M9
    - Recruiting
    - Princess Margaret Cancer Centre
- Quebec
  - Montreal, Quebec, Canada, H4A 3J1
    - Recruiting
    - McGill University Health Centre
France
- - Brest, France, 29200
    - Not yet recruiting
    - CHU Brest, Hopital La Cavale Blanche
  - Paris, France, 75015
    - Not yet recruiting
    - Hôpital Européen Georges Pompidou
  - Villejuif, France, 94800
    - Not yet recruiting
    - Institut Gustave Roussy
- Île-de-France Region
  - Créteil, Île-de-France Region, France, 94000
    - Not yet recruiting
    - Henri Mondor Hospital
Germany
- - Berlin, Germany, 12559
    - Not yet recruiting
    - DRK Kliniken Berlin - Köpenick
  - Dresden, Germany, 01307
    - Not yet recruiting
    - Gemeinschaftspraxis Hämatologie - Onkologie Freiberg-Richter, Jacobasch, Illmer, Wolf
  - Hamburg, Germany, 22763
    - Not yet recruiting
    - Asklepios Altona
Israel
- HA Merkaz
  - Petah Tikva, HA Merkaz, Israel, 4941492
    - Not yet recruiting
    - Rabin Medical Center
- Jerusalem
  - Jerusalem, Jerusalem, Israel, 9112001
    - Not yet recruiting
    - Hadassah Medical Center
- TELL ABĪB
  - Tel Aviv, TELL ABĪB, Israel, 6423906
    - Not yet recruiting
    - Sourasky Medical Center
Italy
- Lecce
  - Tricase, Lecce, Italy, 73039
    - Not yet recruiting
    - Pia Fondazione Di Culto E Di Religione Card. G. Panico
Japan
- - Fukuoka, Japan, 812-8582
    - Recruiting
    - Kyushu University Hospital
  - Osaka, Japan, 540-0006
    - Recruiting
    - National Hospital Organization Osaka Medical Center
- Aichi-ken
  - Nagoya, Aichi-ken, Japan, 464-8681
    - Recruiting
    - Aichi Cancer Center Hospital
- Chiba
  - Chiba, Chiba, Japan, 260-8717
    - Recruiting
    - Chiba cancer center
- Kanagawa
  - Yokohama, Kanagawa, Japan, 241-8515
    - Recruiting
    - Kanagawa cancer center
- Saitama
  - Hidaka, Saitama, Japan, 350-1298
    - Recruiting
    - Saitama Medical University International Medical Center
  - Kitaadachi-gun, Saitama, Japan, 362-0806
    - Recruiting
    - Saitama Prefectural Cancer Center
- Shizuoka
  - Nagaizumi-cho, Shizuoka, Japan, 411-8777
    - Recruiting
    - Shizuoka Cancer Center
- Tokyo
  - Koto-ku, Tokyo, Japan, 135-8550
    - Recruiting
    - The Cancer Institute Hospital of JFCR
Poland
- - Opole, Poland, 45-061
    - Not yet recruiting
    - SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
  - Poznan, Poland, 60-192
    - Not yet recruiting
    - Pratia Poznan
- Silesian Voivodeship
  - Katowice, Silesian Voivodeship, Poland, 40-519
    - Not yet recruiting
    - Pratia Onkologia Katowice
Puerto Rico
- - Mayagüez, Puerto Rico, 00680
    - Recruiting
    - Pan American Center for Oncology Trials - Mayaguez
  - Rio Piedras, Puerto Rico, 00935
    - Recruiting
    - Pan American Center for Oncology Trials, LLC
  - San Juan, Puerto Rico, 00909
    - Recruiting
    - Pan American Center for Oncology Trials, LLC
Spain
- - Barcelona, Spain, 08036
    - Not yet recruiting
    - Hospital Clinic de Barcelona
  - Barcelona, Spain, 08029
    - Not yet recruiting
    - CETIR
  - Córdoba, Spain, 14004
    - Not yet recruiting
    - Hospital Universitario Reina Sofia
  - Málaga, Spain, 29011
    - Not yet recruiting
    - Hospital Regional Universitario de Málaga (Hospital Civil)
- Andalusia
  - Málaga, Andalusia, Spain, 29016
    - Not yet recruiting
    - Clínica Radiológica HLA Mario Gallegos
- Barcelona [barcelona]
  - Barcelona, Barcelona [barcelona], Spain, 08035
    - Not yet recruiting
    - Hospital Universitari Vall d'Hebron
- Cádiz
  - Jerez de la Frontera, Cádiz, Spain, 11407
    - Not yet recruiting
    - Hospital Jerez de la Frontera
Taiwan
- - Kaohsiung City, Taiwan, 807
    - Recruiting
    - Kaohsiung Medical University Chung-Ho Memorial Hospital
  - Kaohsiung City, Taiwan, 83301
    - Not yet recruiting
    - Chang Gung Memorial Hospital at Kaohsiung
  - Tainan, Taiwan, 704
    - Not yet recruiting
    - National Cheng Kung University Hospital
  - Taipei, Taiwan, 11217
    - Not yet recruiting
    - Taipei Veterans General Hospital
  - Taipei, Taiwan, 10002
    - Not yet recruiting
    - National Taiwan University Hospital
  - Taoyuan District, Taiwan, 333
    - Not yet recruiting
    - Chang Gung Medical Foundation-Linkou Branch
United States
- Arizona
  - Chandler, Arizona, United States, 85224
    - Recruiting
    - Ironwood Cancer & Research Centers
  - Gilbert, Arizona, United States, 85297
    - Recruiting
    - Ironwood Cancer & Research Centers
  - Glendale, Arizona, United States, 85306
    - Recruiting
    - Ironwood Cancer & Research Centers
  - Goodyear, Arizona, United States, 85395
    - Recruiting
    - Ironwood Cancer & Research Centers
  - Mesa, Arizona, United States, 85202
    - Recruiting
    - Ironwood Cancer & Research Centers
  - Mesa, Arizona, United States, 85206
    - Recruiting
    - Ironwood Cancer & Research Centers
  - Phoenix, Arizona, United States, 85028
    - Recruiting
    - Ironwood Cancer & Research Centers
  - Scottsdale, Arizona, United States, 85260
    - Recruiting
    - Ironwood Cancer & Research Centers
- Arkansas
  - Fayetteville, Arkansas, United States, 72703
    - Recruiting
    - Highlands Oncology Group
  - Rogers, Arkansas, United States, 72758
    - Recruiting
    - Highlands Oncology Group
  - Springdale, Arkansas, United States, 72762
    - Recruiting
    - Highlands Oncology Group
- Colorado
  - Boulder, Colorado, United States, 80303
    - Recruiting
    - Rocky Mountain Cancer Centers - Boulder
  - Denver, Colorado, United States, 80218
    - Not yet recruiting
    - Intermountain Health Cancer Center Saint Joseph
  - Denver, Colorado, United States, 80218
    - Not yet recruiting
    - Intermountain Health Saint Joseph Hospital - Research Office
  - Denver, Colorado, United States, 80218
    - Not yet recruiting
    - Intermountain Health Saint Joseph Hospital
- Florida
  - Bonita Springs, Florida, United States, 34135
    - Recruiting
    - Florida Cancer Specialists
  - Bradenton, Florida, United States, 34211
    - Recruiting
    - Florida Cancer Specialists
  - Cape Coral, Florida, United States, 33909
    - Recruiting
    - Florida Cancer Specialists
  - Coral Springs, Florida, United States, 33065
    - Recruiting
    - BRCR Global - Coral Springs
  - Fort Myers, Florida, United States, 33908
    - Recruiting
    - Florida Cancer Specialists
  - Fort Myers, Florida, United States, 33905
    - Recruiting
    - Florida Cancer Specialists
  - Melbourne, Florida, United States, 32935
    - Recruiting
    - Cancer Care Centers of Brevard, Inc.
  - N. Venice, Florida, United States, 34275
    - Recruiting
    - Florida Cancer Specialists
  - Naples, Florida, United States, 34102
    - Recruiting
    - Florida Cancer Specialists
  - Orange City, Florida, United States, 32763
    - Recruiting
    - Mid Florida Hematology and Oncology Center
  - Palm Bay, Florida, United States, 32909
    - Recruiting
    - Cancer Care Centers of Brevard, Inc.
  - Port Charlotte, Florida, United States, 33980
    - Recruiting
    - Florida Cancer Specialists
  - Rockledge, Florida, United States, 32955
    - Recruiting
    - Cancer Care Centers of Brevard, Inc.
  - Sarasota, Florida, United States, 34236
    - Recruiting
    - Florida Cancer Specialists
- Illinois
  - Arlington Heights, Illinois, United States, 60005
    - Recruiting
    - Illinois Cancer Specialists
  - Bloomington, Illinois, United States, 61704
    - Recruiting
    - Illinois CancerCare - Bloomington
  - Chicago, Illinois, United States, 60631
    - Recruiting
    - Illinois Cancer Specialists
  - Galesburg, Illinois, United States, 61401
    - Recruiting
    - Illinois CancerCare - Galesburg
  - Hinsdale, Illinois, United States, 60521
    - Recruiting
    - Hope and Healing Cancer Services
  - New Lenox, Illinois, United States, 60451
    - Recruiting
    - Hope and Healing Cancer Services
  - Niles, Illinois, United States, 60714
    - Recruiting
    - Illinois Cancer Specialists
  - Ottawa, Illinois, United States, 61350
    - Recruiting
    - Illinois CancerCare-Ottawa-Fox River Cancer Center
  - Pekin, Illinois, United States, 61554
    - Recruiting
    - Illinois CancerCare-Pekin
  - Peoria, Illinois, United States, 61615
    - Recruiting
    - Illinois Cancer Care
  - Peru, Illinois, United States, 61354
    - Recruiting
    - Illinois CancerCare-Peru - Valley Regional Cancer Center
  - Washington, Illinois, United States, 61571
    - Recruiting
    - Illinois CancerCare-Washington
- Michigan
  - Big Rapids, Michigan, United States, 49307
    - Recruiting
    - The Cancer & Hematology Centers
  - Grand Rapids, Michigan, United States, 49503
    - Recruiting
    - The Cancer & Hematology Centers
  - Grand Rapids, Michigan, United States, 49546
    - Recruiting
    - The Cancer & Hematology Centers
  - Holland, Michigan, United States, 49424
    - Recruiting
    - The Cancer & Hematology Centers
  - Norton Shores, Michigan, United States, 49444
    - Recruiting
    - The Cancer & Hematology Centers
- Minnesota
  - Marshall, Minnesota, United States, 56258
    - Recruiting
    - Avera Cancer Institute- Marshall
- Nebraska
  - Lincoln, Nebraska, United States, 68516
    - Recruiting
    - Cancer Partners of Nebraska
- Nevada
  - Reno, Nevada, United States, 89502
    - Recruiting
    - Renown Regional Medical Center
- New York
  - Camillus, New York, United States, 13031
    - Recruiting
    - Hematology-Oncology Associates of Central New York, PC
  - East Syracuse, New York, United States, 13057
    - Recruiting
    - Hematology-Oncology Associates of Central New York, PC
  - Nyack, New York, United States, 10960
    - Recruiting
    - Hematology Oncology Associates of Rockland
- Ohio
  - Cincinnati, Ohio, United States, 45245
    - Recruiting
    - Oncology Hematology Care - Eastgate
  - Fairfield, Ohio, United States, 45014
    - Recruiting
    - Oncology Hematology Care Clinical Trials, LLC
- Oregon
  - Albany, Oregon, United States, 97321
    - Recruiting
    - Oncology Associates of Oregon, P.C.
  - Clackamas, Oregon, United States, 97015
    - Not yet recruiting
    - Kaiser Permanente Sunnyside Medical Center
  - Corvallis, Oregon, United States, 97330
    - Recruiting
    - Oncology Associates of Oregon, P.C.
  - Eugene, Oregon, United States, 97401
    - Recruiting
    - Oncology Associates of Oregon, P.C.
  - Hillsboro, Oregon, United States, 97124
    - Not yet recruiting
    - Kaiser Permanente Westside Medical Center
  - Portland, Oregon, United States, 97227
    - Not yet recruiting
    - Kaiser Permanente Interstate Medical Office Central
  - Springfield, Oregon, United States, 97477
    - Recruiting
    - Oncology Associates of Oregon, P.C.
- South Dakota
  - Aberdeen, South Dakota, United States, 57401
    - Recruiting
    - Avera Cancer Institute- Aberdeen
  - Mitchell, South Dakota, United States, 57301
    - Recruiting
    - Avera Cancer Institute- Mitchell
  - Pierre, South Dakota, United States, 57501
    - Recruiting
    - Avera Cancer Institute- Pierre
  - Sioux Falls, South Dakota, United States, 57105
    - Recruiting
    - Avera Cancer Institute
  - Yankton, South Dakota, United States, 57078
    - Recruiting
    - AMG Oncology & Hematology -Yankton
- Tennessee
  - Nashville, Tennessee, United States, 37232
    - Not yet recruiting
    - Henry-Joyce Cancer Clinic
- Texas
  - Abilene, Texas, United States, 79606
    - Recruiting
    - Texas Oncology - West Texas
  - Amarillo, Texas, United States, 79124
    - Recruiting
    - Texas Oncology - West Texas
  - Beaumont, Texas, United States, 77702
    - Recruiting
    - Texas Oncology - Gulf Coast
  - Denison, Texas, United States, 75020
    - Recruiting
    - Texas Oncology - Northeast Texas
  - Denton, Texas, United States, 76201
    - Recruiting
    - Texas Oncology - Northeast Texas
  - El Paso, Texas, United States, 79902
    - Recruiting
    - Texas Oncology - West Texas
  - El Paso, Texas, United States, 79915
    - Recruiting
    - Texas Oncology - West Texas
  - El Paso, Texas, United States, 79938
    - Recruiting
    - Texas Oncology - West Texas
  - Flower Mound, Texas, United States, 75028
    - Recruiting
    - Texas Oncology - Northeast Texas
  - Houston, Texas, United States, 77030
    - Recruiting
    - Oncology Consultants P.A.
  - Houston, Texas, United States, 77024
    - Recruiting
    - Texas Oncology - Gulf Coast
  - Houston, Texas, United States, 77054
    - Recruiting
    - Texas Oncology - Gulf Coast
  - Houston, Texas, United States, 77070
    - Recruiting
    - Texas Oncology - Gulf Coast
  - Houston, Texas, United States, 77008
    - Recruiting
    - Oncology Consultants P.A.
  - Houston, Texas, United States, 77024
    - Recruiting
    - Oncology Consultants P.A.
  - Houston, Texas, United States, 77098
    - Recruiting
    - Radnet/Houston Medical Imaging
  - Humble, Texas, United States, 77338
    - Recruiting
    - Texas Oncology - Gulf Coast
  - Irving, Texas, United States, 75063
    - Recruiting
    - US Oncology Investigational Products Center (IPC)
  - Irving, Texas, United States, 75063
    - Recruiting
    - US Oncology Investigational Products Center
  - Longview, Texas, United States, 75601
    - Recruiting
    - Texas Oncology - Northeast Texas
  - Midland, Texas, United States, 79701
    - Recruiting
    - Texas Oncology - West Texas
  - Odessa, Texas, United States, 79761
    - Recruiting
    - Texas Oncology - West Texas
  - Pearland, Texas, United States, 77584
    - Recruiting
    - Texas Oncology - Gulf Coast
  - Sugar Land, Texas, United States, 77479
    - Recruiting
    - Texas Oncology - Gulf Coast
  - The Woodlands, Texas, United States, 77380
    - Recruiting
    - Texas Oncology - Gulf Coast
  - Tyler, Texas, United States, 75702
    - Recruiting
    - Texas Oncology - Northeast Texas
  - Wichita Falls, Texas, United States, 76310
    - Recruiting
    - Texas Oncology - West Texas
- Virginia
  - Arlington, Virginia, United States, 22201
    - Recruiting
    - Virginia Cancer Specialists, PC
  - Blacksburg, Virginia, United States, 24060
    - Recruiting
    - Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
  - Fairfax, Virginia, United States, 22031
    - Recruiting
    - Virginia Cancer Specialists, PC
  - Low Moor, Virginia, United States, 24457
    - Recruiting
    - Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
  - Manassas, Virginia, United States, 20110
    - Recruiting
    - Virginia Cancer Specialists, PC
  - Mechanicsville, Virginia, United States, 23116
    - Not yet recruiting
    - Virginia Cancer Institute
  - Midlothian, Virginia, United States, 23112
    - Not yet recruiting
    - Virginia Cancer Institute
  - Petersburg, Virginia, United States, 23805
    - Not yet recruiting
    - Virginia Cancer Institute
  - Reston, Virginia, United States, 20190
    - Recruiting
    - Virginia Cancer Specialists, PC
  - Richmond, Virginia, United States, 23235
    - Not yet recruiting
    - Virginia Cancer Institute
  - Richmond, Virginia, United States, 23229
    - Not yet recruiting
    - Virginia Cancer Institute
  - Roanoke, Virginia, United States, 24014
    - Recruiting
    - Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
  - Salem, Virginia, United States, 24153
    - Recruiting
    - Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
  - Woodbridge, Virginia, United States, 22191
    - Recruiting
    - Virginia Cancer Specialists, PC
  - Wytheville, Virginia, United States, 24382
    - Recruiting
    - Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Histological or cytological confirmed colorectal adenocarcinoma.
Evidence of Stage IV metastatic disease.
No prior systemic therapy for metastatic disease.
Eastern Cooperative Oncology Group performance status (ECOG) 0-1
At least one measurable lesion according to RECIST 1.1 per Investigator assessment.
Adequate hepatic, liver, and renal function

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

Locally confirmed BRAF V600E mutation
Locally confirmed microsatellite instability (MSI)-high or DNA mismatch repair deficiency (dMMR) colorectal cancer
Participants with known active symptomatic CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression
Clinically significant risk of hemorrhage or fistula
Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study
History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
Any Grade ≥3 bleeding/hemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events
Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose
Participants with active autoimmune diseases requiring systemic treatment within the past 2 years
Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PF-08634404 + Chemotherapy Participants will receive PF-08634404 intravenously (IV) in combination with Chemotherapy.	Drug: PF-08634404 Solution for infusion Drug: Chemotherapy Injection for intravenous use
Active Comparator: Bevacizumab + Chemotherapy Participants will receive bevacizumab IV in combination with Chemotherapy.	Drug: Chemotherapy Injection for intravenous use Biological: Bevacizumab Injection for intravenous use Other Names: Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) Time Frame: Approximately 4 years	Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective progressive disease (PD) assessed by BICR per RECIST 1.1, or death due to any cause, whichever occurs first.	Approximately 4 years
Overall survival (OS) Time Frame: Approximately 4 years	Overall survival defined as the time from the date of randomization to the date of death due to any cause.	Approximately 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS per RECIST 1.1 by investigator assessment Time Frame: Approximately 4 years	Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of the first documentation of objective PD assessed by investigator per RECIST 1.1, or death due to any cause, whichever occurs first.	Approximately 4 years
Objective Response Rate (ORR) by BICR Time Frame: Approximately 4 years	The proportion of participants who have a confirmed CR or PR, as best overall response assessed by BICR as per RECIST 1.1.	Approximately 4 years
Objective Response Rate (ORR) by investigator Time Frame: Approximately 4 years	The proportion of participants who have a confirmed CR or PR, as best overall response assessed by investigator as per RECIST 1.1.	Approximately 4 years
Duration of Response (DOR) by BICR Time Frame: Approximately 4 years	The time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of the first documentation of PD as determined by BICR assessment per RECIST 1.1, or death due to any cause, whichever occurs first.	Approximately 4 years
DOR by investigator Time Frame: Approximately 4 years	The time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of the first documentation of PD as determined by Investigator per RECIST 1.1, or death due to any cause, whichever occurs first.	Approximately 4 years
PFS2 (PFS after next-line therapy) by investigator Time Frame: Approximately 4 years	PFS2 is defined as the time from the date of randomization to the date of second objective disease progression or death due to any cause, whichever occurs first. Second objective disease progression is PD after the start of subsequent anticancer therapy (excluding curative surgery) as assessed by the investigator.	Approximately 4 years
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Time Frame: Through 90 days after the last study intervention; Approximately 4 years		Through 90 days after the last study intervention; Approximately 4 years
Number of Participants With Clinical Laboratory Abnormalities Time Frame: Through 90 days after the last study intervention; Approximately 4 years		Through 90 days after the last study intervention; Approximately 4 years
Pharmacokinetics (PK): Serum concentration of PF-08634404 Time Frame: Approximately 21 months		Approximately 21 months
Immunogenicity: Incidence of positive Anti-Drug Antibody (ADA) Time Frame: Approximately 21 months	To characterize the immunogenicity of PF-08634404	Approximately 21 months
Mean score change from baseline in participant reported function and symptoms scales per EORTC QLQ-CR29 Time Frame: Approximately 4 years	The EORTC QLQ-CR29 is a supplemental colorectal cancer-specific module with measures of symptoms associated with colorectal cancer.	Approximately 4 years
Time to definitive deterioration (TTdD) in the global health status/QoL score on the EORTC QLQ-C30 Time Frame: Approximately 4 years	TTdD is defined as the time from date of randomization to first onset of Patient Reported Outcome (PRO) deterioration without subsequent recovery.	Approximately 4 years
Time to definitive deterioration (TTdD) in participant reported function and symptoms per EORTC QLQ-CR29 Time Frame: Approximately 4 years	TTdD is defined as the time from date of randomization to first onset of Patient Reported Outcome (PRO) deterioration without subsequent recovery.	Approximately 4 years
Mean scores and Change from baseline in the global health status/quality of life (QoL) score on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Time Frame: Approximately 4 years	The EORTC QLQ-C30 is a questionnaire for quantitative measure of health-related quality of life pertinent to participants with a broad range of cancers who are participating in international clinical trials.	Approximately 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

To obtain contact information for a study center near you, click here.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2025

Primary Completion (Estimated)

March 29, 2030

Study Completion (Estimated)

August 1, 2031

Study Registration Dates

First Submitted

October 28, 2025

First Submitted That Met QC Criteria

October 28, 2025

First Posted (Actual)

October 30, 2025

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

C6461003
2025-523521-18-00 (Ctis)
Symbiotic-GI-03 (Other Identifier: Pfizer)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Clinical Trials on PF-08634404

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Symbiotic-Lung-20: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Different Anticancer Agents in Advanced Cancers

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United States, Taiwan, Japan, Puerto Rico
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GOG Foundation

Not yet recruiting

Symbiotic-GYN-18: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Advanced or Recurrent MMR-proficient Endometrial Cancer

Endometrial Neoplasms | Endometrial Cancer
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Recruiting

Symbiotic-Lung-14: A Study to Learn About the Study Medicine Called PF08634404 in Combination With Chemotherapy in Adult Participants With Transformed Small Cell Lung Cancer

Lung Neoplasms | Small Cell Lung Cancer | Carcinoma, Small Cell Lung | Small Cell Lung Cancer ( SCLC ) | Transformed Small Cell Lung Cancer | Small Cell Cancer Of The Lung

United States, Japan
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Recruiting

Symbiotic-GU-08: A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Anticancer Therapies in Adults With Locally Advanced or Metastatic Renal Cell Cancer

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United States, Japan, Australia
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Recruiting

Symbiotic-Lung-04: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Extensive-Stage Small Cell Lung Cancer

Small Cell Lung Cancer (SCLC)

Japan, Taiwan, United States, Puerto Rico, Spain, Australia, France
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Not yet recruiting

Symbiotic-Lung-10: A Study to Learn About PF-08634404 Alone or in Combination in Early-stage or Locally Advanced NSCLC

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Recruiting

Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer

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Symbiotic-Lung-01 : A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

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A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer

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Symbiotic-GI-13: A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatment in Adult Participants With a Liver Cancer Called Hepatocellular Carcinoma, That is Too Advanced to be Removed by Surgery and May Have Spread to Other Parts of the Body.

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Symbiotic-GI-03: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

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Phase

Contacts and Locations

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Accepts Healthy Volunteers

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Design Details

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Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

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Secondary Outcome Measures

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Time Frame

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Last Update Submitted That Met QC Criteria

Last Verified

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IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Digestive System Diseases

Clinical Trials on PF-08634404

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