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

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Investigational drug late phase More information Active drug More information Moderate burden on patient More information

Trial Details

Sponsor: Pfizer (industry)

Phase: 3

Start date: Dec. 11, 2025

Planned enrollment: 800

Trial ID: NCT07222800
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More trial details at ClinicalTrials.gov More info

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Investigational Drug AI Analysis

chevron Show for: PF-08634404 (SSGJ-707)

TrialFetch AI Analysis

Goal: Determine whether PF-08634404 plus chemotherapy improves outcomes compared with bevacizumab plus chemotherapy as first-line treatment for metastatic colorectal cancer, while assessing safety and quality of life.

Patients: Adults with previously untreated stage IV colorectal adenocarcinoma, ECOG performance status 0–1, measurable disease, and adequate organ function. Key exclusions include BRAF V600E mutation, MSI-high or dMMR disease, symptomatic CNS disease, significant bleeding risk, and clinically significant cardiovascular disease.

Design: Randomized, double-blind, active-controlled study assigning participants to one of two intravenous combination regimens. Treatment continues while beneficial and tolerable, followed by safety and survival follow-up.

Treatments: The experimental regimen combines chemotherapy with PF-08634404 (SSGJ-707), an investigational bispecific antibody targeting PD-1 and VEGF to combine immune-checkpoint blockade with inhibition of tumor-associated blood-vessel growth. Early phase 2 reports have described responses in metastatic colorectal cancer, but the antibody’s independent contribution and survival benefit remain unproven. In a small nonsquamous NSCLC phase 2 comparison, response rates were 58.6% with PF-08634404 plus chemotherapy versus 38.7% with tislelizumab plus chemotherapy; these findings cannot establish efficacy in colorectal cancer. The comparator combines chemotherapy with bevacizumab, an established anti-VEGF treatment for metastatic colorectal cancer.

Outcomes: Primary endpoints are blinded independent central review–assessed progression-free survival by RECIST 1.1 and overall survival. Secondary measures include response rate and duration, investigator-assessed progression-free survival, progression after next-line therapy, adverse events, laboratory abnormalities, pharmacokinetics, anti-drug antibodies, and patient-reported quality of life and symptoms.

Burden on patient: Moderate burden: repeated site visits for IV infusions, monitoring, imaging and laboratory tests over potentially prolonged treatment, plus blood sampling for pharmacokinetics and immunogenicity and quality-of-life questionnaires. A safety visit occurs 30–37 days after treatment stops, with follow-up approximately every 12 weeks. No mandatory research biopsy is specified.

Last updated: Sep 2026

Eligibility More information

Caution: ClinicalTrials.gov appears to have newer eligibility criteria than the version saved here. Review the current criteria in ClinicalTrials.gov.

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Sites (156)

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Icon Cancer Centre Wesley

Auchenflower, Queensland, 4066, Australia

No email / No phone

Status: Recruiting

Icon Cancer Centre Hobart

Hobart, Tasmania, 7000, Australia

No email / No phone

Status: Recruiting

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

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Status: Recruiting

Centro de Oncologia - CEON+ - Unidade São Caetano do Sul

São Caetano do Sul, São Paulo, 09541-270, Brazil

No email / No phone

Status: Recruiting

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

No email / No phone

Status: Recruiting

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

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Status: Recruiting

Kyushu University Hospital

Fukuoka, 812-8582, Japan

No email / No phone

Status: Recruiting

National Hospital Organization Osaka Medical Center

Osaka, 540-0006, Japan

No email / No phone

Status: Recruiting

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, 464-8681, Japan

No email / No phone

Status: Recruiting

Chiba cancer center

Chiba, Chiba, 260-8717, Japan

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Status: Recruiting

Kanagawa cancer center

Yokohama, Kanagawa, 241-8515, Japan

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Status: Recruiting

Saitama Medical University International Medical Center

Hidaka, Saitama, 350-1298, Japan

No email / No phone

Status: Recruiting

Saitama Prefectural Cancer Center

Kitaadachi-gun, Saitama, 362-0806, Japan

No email / No phone

Status: Recruiting

Shizuoka Cancer Center

Nagaizumi-cho, Shizuoka, 411-8777, Japan

No email / No phone

Status: Recruiting

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, 135-8550, Japan

No email / No phone

Status: Recruiting

Pan American Center for Oncology Trials - Mayaguez

Mayagüez, 00680, Puerto Rico

No email / No phone

Status: Recruiting

Pan American Center for Oncology Trials, LLC

San Juan, 00909, Puerto Rico

No email / No phone

Status: Recruiting

Pan American Center for Oncology Trials, LLC

Rio Piedras, 00935, Puerto Rico

No email / No phone

Status: Recruiting

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

No email / No phone

Status: Recruiting

Ironwood Cancer & Research Centers

Scottsdale, Arizona, 85260, United States

No email / No phone

Status: Recruiting

Ironwood Cancer & Research Centers

Phoenix, Arizona, 85028, United States

No email / No phone

Status: Recruiting

Ironwood Cancer & Research Centers

Mesa, Arizona, 85206, United States

No email / No phone

Status: Recruiting

Ironwood Cancer & Research Centers

Chandler, Arizona, 85224, United States

No email / No phone

Status: Recruiting

Ironwood Cancer & Research Centers

Mesa, Arizona, 85202, United States

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Status: Recruiting

Ironwood Cancer & Research Centers

Goodyear, Arizona, 85395, United States

No email / No phone

Status: Recruiting

Ironwood Cancer & Research Centers

Glendale, Arizona, 85306, United States

No email / No phone

Status: Recruiting

Ironwood Cancer & Research Centers

Gilbert, Arizona, 85297, United States

No email / No phone

Status: Recruiting

Highlands Oncology Group

Springdale, Arkansas, 72762, United States

No email / No phone

Status: Recruiting

Highlands Oncology Group

Rogers, Arkansas, 72758, United States

No email / No phone

Status: Recruiting

Highlands Oncology Group

Fayetteville, Arkansas, 72703, United States

No email / No phone

Status: Recruiting

Rocky Mountain Cancer Centers - Boulder

Boulder, Colorado, 80303, United States

No email / No phone

Status: Recruiting

BRCR Global - Coral Springs

Coral Springs, Florida, 33065, United States

No email / No phone

Status: Recruiting

Cancer Care Centers of Brevard, Inc.

Melbourne, Florida, 32935, United States

No email / No phone

Status: Recruiting

Cancer Care Centers of Brevard, Inc.

Palm Bay, Florida, 32909, United States

No email / No phone

Status: Recruiting

Cancer Care Centers of Brevard, Inc.

Rockledge, Florida, 32955, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Fort Myers, Florida, 33905, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Bonita Springs, Florida, 34135, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Bradenton, Florida, 34211, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Cape Coral, Florida, 33909, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Fort Myers, Florida, 33908, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

N. Venice, Florida, 34275, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Naples, Florida, 34102, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Port Charlotte, Florida, 33980, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Sarasota, Florida, 34236, United States

No email / No phone

Status: Recruiting

Mid Florida Hematology and Oncology Center

Orange City, Florida, 32763, United States

No email / No phone

Status: Recruiting

Hope and Healing Cancer Services

New Lenox, Illinois, 60451, United States

No email / No phone

Status: Recruiting

Hope and Healing Cancer Services

Hinsdale, Illinois, 60521, United States

No email / No phone

Status: Recruiting

Illinois Cancer Care

Peoria, Illinois, 61615, United States

No email / No phone

Status: Recruiting

Illinois Cancer Specialists

Niles, Illinois, 60714, United States

No email / No phone

Status: Recruiting

Illinois Cancer Specialists

Arlington Heights, Illinois, 60005, United States

No email / No phone

Status: Recruiting

Illinois Cancer Specialists

Chicago, Illinois, 60631, United States

No email / No phone

Status: Recruiting

Illinois CancerCare - Bloomington

Bloomington, Illinois, 61704, United States

No email / No phone

Status: Recruiting

Illinois CancerCare - Galesburg

Galesburg, Illinois, 61401, United States

No email / No phone

Status: Recruiting

Illinois CancerCare-Ottawa-Fox River Cancer Center

Ottawa, Illinois, 61350, United States

No email / No phone

Status: Recruiting

Illinois CancerCare-Pekin

Pekin, Illinois, 61554, United States

No email / No phone

Status: Recruiting

Illinois CancerCare-Peru - Valley Regional Cancer Center

Peru, Illinois, 61354, United States

No email / No phone

Status: Recruiting

Illinois CancerCare-Washington

Washington, Illinois, 61571, United States

No email / No phone

Status: Recruiting

The Cancer & Hematology Centers

Norton Shores, Michigan, 49444, United States

No email / No phone

Status: Recruiting

The Cancer & Hematology Centers

Holland, Michigan, 49424, United States

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Status: Recruiting

The Cancer & Hematology Centers

Big Rapids, Michigan, 49307, United States

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Status: Recruiting

The Cancer & Hematology Centers

Grand Rapids, Michigan, 49503, United States

No email / No phone

Status: Recruiting

The Cancer & Hematology Centers

Grand Rapids, Michigan, 49546, United States

No email / No phone

Status: Recruiting

Avera Cancer Institute- Marshall

Marshall, Minnesota, 56258, United States

No email / No phone

Status: Recruiting

Cancer Partners of Nebraska

Lincoln, Nebraska, 68516, United States

No email / No phone

Status: Recruiting

Renown Regional Medical Center

Reno, Nevada, 89502, United States

No email / No phone

Status: Recruiting

Hematology Oncology Associates of Rockland

Nyack, New York, 10960, United States

No email / No phone

Status: Recruiting

Hematology-Oncology Associates of Central New York, PC

East Syracuse, New York, 13057, United States

No email / No phone

Status: Recruiting

Hematology-Oncology Associates of Central New York, PC

Camillus, New York, 13031, United States

No email / No phone

Status: Recruiting

Oncology Hematology Care - Eastgate

Cincinnati, Ohio, 45245, United States

No email / No phone

Status: Recruiting

Oncology Hematology Care Clinical Trials, LLC

Fairfield, Ohio, 45014, United States

No email / No phone

Status: Recruiting

Oncology Associates of Oregon, P.C.

Eugene, Oregon, 97401, United States

No email / No phone

Status: Recruiting

Oncology Associates of Oregon, P.C.

Corvallis, Oregon, 97330, United States

No email / No phone

Status: Recruiting

Oncology Associates of Oregon, P.C.

Albany, Oregon, 97321, United States

No email / No phone

Status: Recruiting

Oncology Associates of Oregon, P.C.

Springfield, Oregon, 97477, United States

No email / No phone

Status: Recruiting

AMG Oncology & Hematology -Yankton

Yankton, South Dakota, 57078, United States

No email / No phone

Status: Recruiting

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

No email / No phone

Status: Recruiting

Avera Cancer Institute- Aberdeen

Aberdeen, South Dakota, 57401, United States

No email / No phone

Status: Recruiting

Avera Cancer Institute- Mitchell

Mitchell, South Dakota, 57301, United States

No email / No phone

Status: Recruiting

Avera Cancer Institute- Pierre

Pierre, South Dakota, 57501, United States

No email / No phone

Status: Recruiting

Oncology Consultants P.A.

Houston, Texas, 77024, United States

No email / No phone

Status: Recruiting

Oncology Consultants P.A.

Houston, Texas, 77030, United States

No email / No phone

Status: Recruiting

Oncology Consultants P.A.

Houston, Texas, 77008, United States

No email / No phone

Status: Recruiting

Radnet/Houston Medical Imaging

Houston, Texas, 77098, United States

No email / No phone

Status: Recruiting

Texas Oncology - Gulf Coast

Houston, Texas, 77024, United States

No email / No phone

Status: Recruiting

Texas Oncology - Gulf Coast

Houston, Texas, 77054, United States

No email / No phone

Status: Recruiting

Texas Oncology - Gulf Coast

Houston, Texas, 77070, United States

No email / No phone

Status: Recruiting

Texas Oncology - Gulf Coast

Humble, Texas, 77338, United States

No email / No phone

Status: Recruiting

Texas Oncology - Gulf Coast

Pearland, Texas, 77584, United States

No email / No phone

Status: Recruiting

Texas Oncology - Gulf Coast

Sugar Land, Texas, 77479, United States

No email / No phone

Status: Recruiting

Texas Oncology - Gulf Coast

The Woodlands, Texas, 77380, United States

No email / No phone

Status: Recruiting

Texas Oncology - Gulf Coast

Beaumont, Texas, 77702, United States

No email / No phone

Status: Recruiting

Texas Oncology - Northeast Texas

Longview, Texas, 75601, United States

No email / No phone

Status: Recruiting

Texas Oncology - Northeast Texas

Tyler, Texas, 75702, United States

No email / No phone

Status: Recruiting

Texas Oncology - Northeast Texas

Flower Mound, Texas, 75028, United States

No email / No phone

Status: Recruiting

Texas Oncology - Northeast Texas

Denton, Texas, 76201, United States

No email / No phone

Status: Recruiting

Texas Oncology - Northeast Texas

Denison, Texas, 75020, United States

No email / No phone

Status: Recruiting

Texas Oncology - West Texas

Amarillo, Texas, 79124, United States

No email / No phone

Status: Recruiting

Texas Oncology - West Texas

Midland, Texas, 79701, United States

No email / No phone

Status: Recruiting

Texas Oncology - West Texas

Odessa, Texas, 79761, United States

No email / No phone

Status: Recruiting

Texas Oncology - West Texas

Wichita Falls, Texas, 76310, United States

No email / No phone

Status: Recruiting

Texas Oncology - West Texas

El Paso, Texas, 79938, United States

No email / No phone

Status: Recruiting

Texas Oncology - West Texas

El Paso, Texas, 79915, United States

No email / No phone

Status: Recruiting

Texas Oncology - West Texas

El Paso, Texas, 79902, United States

No email / No phone

Status: Recruiting

Texas Oncology - West Texas

Abilene, Texas, 79606, United States

No email / No phone

Status: Recruiting

US Oncology Investigational Products Center

Irving, Texas, 75063, United States

No email / No phone

Status: Recruiting

US Oncology Investigational Products Center (IPC)

Irving, Texas, 75063, United States

No email / No phone

Status: Recruiting

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Wytheville, Virginia, 24382, United States

No email / No phone

Status: Recruiting

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Salem, Virginia, 24153, United States

No email / No phone

Status: Recruiting

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Roanoke, Virginia, 24014, United States

No email / No phone

Status: Recruiting

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Low Moor, Virginia, 24457, United States

No email / No phone

Status: Recruiting

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Blacksburg, Virginia, 24060, United States

No email / No phone

Status: Recruiting

Virginia Cancer Specialists, PC

Woodbridge, Virginia, 22191, United States

No email / No phone

Status: Recruiting

Virginia Cancer Specialists, PC

Reston, Virginia, 20190, United States

No email / No phone

Status: Recruiting

Virginia Cancer Specialists, PC

Manassas, Virginia, 20110, United States

No email / No phone

Status: Recruiting

Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031, United States

No email / No phone

Status: Recruiting

Virginia Cancer Specialists, PC

Arlington, Virginia, 22201, United States

No email / No phone

Status: Recruiting

AZ Sint-Lucas

Ghent, 9000, Belgium

No email / No phone

Status: Not yet recruiting

Grand Hôpital de Charleroi

Charleroi, Hainaut, 6060, Belgium

No email / No phone

Status: Not yet recruiting

CHU Brest, Hopital La Cavale Blanche

Brest, 29200, France

No email / No phone

Status: Not yet recruiting

Hôpital Européen Georges Pompidou

Paris, 75015, France

No email / No phone

Status: Not yet recruiting

Institut Gustave Roussy

Villejuif, 94800, France

No email / No phone

Status: Not yet recruiting

Henri Mondor Hospital

Créteil, Île-de-France Region, 94000, France

No email / No phone

Status: Not yet recruiting

Asklepios Altona

Hamburg, 22763, Germany

No email / No phone

Status: Not yet recruiting

DRK Kliniken Berlin - Köpenick

Berlin, 12559, Germany

No email / No phone

Status: Not yet recruiting

Gemeinschaftspraxis Hämatologie - Onkologie Freiberg-Richter, Jacobasch, Illmer, Wolf

Dresden, 01307, Germany

No email / No phone

Status: Not yet recruiting

Rabin Medical Center

Petah Tikva, HA Merkaz, 4941492, Israel

No email / No phone

Status: Not yet recruiting

Hadassah Medical Center

Jerusalem, Jerusalem, 9112001, Israel

No email / No phone

Status: Not yet recruiting

Sourasky Medical Center

Tel Aviv, TELL ABĪB, 6423906, Israel

No email / No phone

Status: Not yet recruiting

Pia Fondazione Di Culto E Di Religione Card. G. Panico

Tricase, Lecce, 73039, Italy

No email / No phone

Status: Not yet recruiting

Pratia Poznań

Poznan, 60-192, Poland

No email / No phone

Status: Not yet recruiting

SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu

Opole, 45-061, Poland

No email / No phone

Status: Not yet recruiting

Pratia Onkologia Katowice

Katowice, Silesian Voivodeship, 40-519, Poland

No email / No phone

Status: Not yet recruiting

CETIR

Barcelona, 08029, Spain

No email / No phone

Status: Not yet recruiting

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

No email / No phone

Status: Not yet recruiting

Hospital Regional Universitario de Malaga (Hospital Civil)

Málaga, 29011, Spain

No email / No phone

Status: Not yet recruiting

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

No email / No phone

Status: Not yet recruiting

Clínica Radiológica HLA Mario Gallegos

Málaga, Andalusia, 29016, Spain

No email / No phone

Status: Not yet recruiting

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [barcelona], 08035, Spain

No email / No phone

Status: Not yet recruiting

Hospital Jerez de la Frontera

Jerez de la Frontera, Cádiz, 11407, Spain

No email / No phone

Status: Not yet recruiting

Chang Gung Medical Foundation-Linkou Branch

Taoyuan District, 333, Taiwan

No email / No phone

Status: Not yet recruiting

Chang Gung Memorial Hospital at Kaohsiung

Kaohsiung City, 83301, Taiwan

No email / No phone

Status: Not yet recruiting

National Cheng Kung University Hospital

Tainan, 704, Taiwan

No email / No phone

Status: Not yet recruiting

National Taiwan University Hospital

Taipei, 10002, Taiwan

No email / No phone

Status: Not yet recruiting

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

No email / No phone

Status: Not yet recruiting

Intermountain Health Cancer Center Saint Joseph

Denver, Colorado, 80218, United States

No email / No phone

Status: Not yet recruiting

Intermountain Health Saint Joseph Hospital

Denver, Colorado, 80218, United States

No email / No phone

Status: Not yet recruiting

Intermountain Health Saint Joseph Hospital - Research Office

Denver, Colorado, 80218, United States

No email / No phone

Status: Not yet recruiting

Kaiser Permanente Interstate Medical Office Central

Portland, Oregon, 97227, United States

No email / No phone

Status: Not yet recruiting

Kaiser Permanente Sunnyside Medical Center

Clackamas, Oregon, 97015, United States

No email / No phone

Status: Not yet recruiting

Kaiser Permanente Westside Medical Center

Hillsboro, Oregon, 97124, United States

No email / No phone

Status: Not yet recruiting

Henry-Joyce Cancer Clinic

Nashville, Tennessee, 37232, United States

No email / No phone

Status: Not yet recruiting

Virginia Cancer Institute

Richmond, Virginia, 23235, United States

No email / No phone

Status: Not yet recruiting

Virginia Cancer Institute

Richmond, Virginia, 23229, United States

No email / No phone

Status: Not yet recruiting

Virginia Cancer Institute

Petersburg, Virginia, 23805, United States

No email / No phone

Status: Not yet recruiting

Virginia Cancer Institute

Midlothian, Virginia, 23112, United States

No email / No phone

Status: Not yet recruiting

Virginia Cancer Institute

Mechanicsville, Virginia, 23116, United States

No email / No phone

Status: Not yet recruiting

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