Sponsor: Pfizer (industry)
Phase: 3
Start date: Dec. 11, 2025
Planned enrollment: 800
PF-08634404 (SSGJ-707) is an investigational bispecific antibody being studied for advanced cancers, including non-small cell lung cancer (NSCLC). Human phase 2 results have been reported, but the evidence remains preliminary: the principal findings are from conference abstracts, and a phase 3 NSCLC trial is intended to test the treatment more definitively. (ascopubs.org)
The antibody binds both PD-1, an immune checkpoint, and VEGF, a driver of blood-vessel growth. It is designed to combine PD-1 blockade with VEGF inhibition in one molecule. (ascopubs.org)
In the NSCLC monotherapy study, 42.2% of 83 patients across dose groups had a treatment-related adverse event of grade 3 or higher. The most frequent were pneumonia (8.4%), hypertension (7.2%), and coughing up blood (hemoptysis; 6.0%). In the NSCLC chemotherapy study, grade 3 or higher treatment-related events occurred in 39.0% of patients receiving the 10 mg/kg SSGJ-707 regimen, versus 32.8% receiving tislelizumab; three treatment-related deaths were reported in the SSGJ-707 group, including two attributed to hemoptysis. Safety estimates may change with larger studies and longer follow-up. (ascopubs.org)
Last updated: Sep 2026
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
Caution: ClinicalTrials.gov appears to have newer eligibility criteria than the version saved here. Review the current criteria in ClinicalTrials.gov.
Inclusion Criteria:
* Histological or cytological confirmed colorectal adenocarcinoma.
* Evidence of Stage IV 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
Auchenflower, Queensland, 4066, Australia
No email / No phone
Status: Recruiting
Hobart, Tasmania, 7000, Australia
No email / No phone
Status: Recruiting
Melbourne, Victoria, 3000, Australia
No email / No phone
Status: Recruiting
São Caetano do Sul, São Paulo, 09541-270, Brazil
No email / No phone
Status: Recruiting
Toronto, Ontario, M5G 2M9, Canada
No email / No phone
Status: Recruiting
Montreal, Quebec, H4A 3J1, Canada
No email / No phone
Status: Recruiting
Fukuoka, 812-8582, Japan
No email / No phone
Status: Recruiting
Osaka, 540-0006, Japan
No email / No phone
Status: Recruiting
Nagoya, Aichi-ken, 464-8681, Japan
No email / No phone
Status: Recruiting
Chiba, Chiba, 260-8717, Japan
No email / No phone
Status: Recruiting
Yokohama, Kanagawa, 241-8515, Japan
No email / No phone
Status: Recruiting
Hidaka, Saitama, 350-1298, Japan
No email / No phone
Status: Recruiting
Kitaadachi-gun, Saitama, 362-0806, Japan
No email / No phone
Status: Recruiting
Nagaizumi-cho, Shizuoka, 411-8777, Japan
No email / No phone
Status: Recruiting
Koto-ku, Tokyo, 135-8550, Japan
No email / No phone
Status: Recruiting
Mayagüez, 00680, Puerto Rico
No email / No phone
Status: Recruiting
San Juan, 00909, Puerto Rico
No email / No phone
Status: Recruiting
Rio Piedras, 00935, Puerto Rico
No email / No phone
Status: Recruiting
Kaohsiung City, 807, Taiwan
No email / No phone
Status: Recruiting
Scottsdale, Arizona, 85260, United States
No email / No phone
Status: Recruiting
Phoenix, Arizona, 85028, United States
No email / No phone
Status: Recruiting
Mesa, Arizona, 85206, United States
No email / No phone
Status: Recruiting
Chandler, Arizona, 85224, United States
No email / No phone
Status: Recruiting
Mesa, Arizona, 85202, United States
No email / No phone
Status: Recruiting
Goodyear, Arizona, 85395, United States
No email / No phone
Status: Recruiting
Glendale, Arizona, 85306, United States
No email / No phone
Status: Recruiting
Gilbert, Arizona, 85297, United States
No email / No phone
Status: Recruiting
Springdale, Arkansas, 72762, United States
No email / No phone
Status: Recruiting
Rogers, Arkansas, 72758, United States
No email / No phone
Status: Recruiting
Fayetteville, Arkansas, 72703, United States
No email / No phone
Status: Recruiting
Boulder, Colorado, 80303, United States
No email / No phone
Status: Recruiting
Coral Springs, Florida, 33065, United States
No email / No phone
Status: Recruiting
Melbourne, Florida, 32935, United States
No email / No phone
Status: Recruiting
Palm Bay, Florida, 32909, United States
No email / No phone
Status: Recruiting
Rockledge, Florida, 32955, United States
No email / No phone
Status: Recruiting
Fort Myers, Florida, 33905, United States
No email / No phone
Status: Recruiting
Bonita Springs, Florida, 34135, United States
No email / No phone
Status: Recruiting
Bradenton, Florida, 34211, United States
No email / No phone
Status: Recruiting
Cape Coral, Florida, 33909, United States
No email / No phone
Status: Recruiting
Fort Myers, Florida, 33908, United States
No email / No phone
Status: Recruiting
N. Venice, Florida, 34275, United States
No email / No phone
Status: Recruiting
Naples, Florida, 34102, United States
No email / No phone
Status: Recruiting
Port Charlotte, Florida, 33980, United States
No email / No phone
Status: Recruiting
Sarasota, Florida, 34236, United States
No email / No phone
Status: Recruiting
Orange City, Florida, 32763, United States
No email / No phone
Status: Recruiting
New Lenox, Illinois, 60451, United States
No email / No phone
Status: Recruiting
Hinsdale, Illinois, 60521, United States
No email / No phone
Status: Recruiting
Peoria, Illinois, 61615, United States
No email / No phone
Status: Recruiting
Niles, Illinois, 60714, United States
No email / No phone
Status: Recruiting
Arlington Heights, Illinois, 60005, United States
No email / No phone
Status: Recruiting
Chicago, Illinois, 60631, United States
No email / No phone
Status: Recruiting
Bloomington, Illinois, 61704, United States
No email / No phone
Status: Recruiting
Galesburg, Illinois, 61401, United States
No email / No phone
Status: Recruiting
Ottawa, Illinois, 61350, United States
No email / No phone
Status: Recruiting
Pekin, Illinois, 61554, United States
No email / No phone
Status: Recruiting
Peru, Illinois, 61354, United States
No email / No phone
Status: Recruiting
Washington, Illinois, 61571, United States
No email / No phone
Status: Recruiting
Norton Shores, Michigan, 49444, United States
No email / No phone
Status: Recruiting
Holland, Michigan, 49424, United States
No email / No phone
Status: Recruiting
Big Rapids, Michigan, 49307, United States
No email / No phone
Status: Recruiting
Grand Rapids, Michigan, 49503, United States
No email / No phone
Status: Recruiting
Grand Rapids, Michigan, 49546, United States
No email / No phone
Status: Recruiting
Marshall, Minnesota, 56258, United States
No email / No phone
Status: Recruiting
Lincoln, Nebraska, 68516, United States
No email / No phone
Status: Recruiting
Reno, Nevada, 89502, United States
No email / No phone
Status: Recruiting
Nyack, New York, 10960, United States
No email / No phone
Status: Recruiting
East Syracuse, New York, 13057, United States
No email / No phone
Status: Recruiting
Camillus, New York, 13031, United States
No email / No phone
Status: Recruiting
Cincinnati, Ohio, 45245, United States
No email / No phone
Status: Recruiting
Fairfield, Ohio, 45014, United States
No email / No phone
Status: Recruiting
Eugene, Oregon, 97401, United States
No email / No phone
Status: Recruiting
Corvallis, Oregon, 97330, United States
No email / No phone
Status: Recruiting
Albany, Oregon, 97321, United States
No email / No phone
Status: Recruiting
Springfield, Oregon, 97477, United States
No email / No phone
Status: Recruiting
Yankton, South Dakota, 57078, United States
No email / No phone
Status: Recruiting
Sioux Falls, South Dakota, 57105, United States
No email / No phone
Status: Recruiting
Aberdeen, South Dakota, 57401, United States
No email / No phone
Status: Recruiting
Mitchell, South Dakota, 57301, United States
No email / No phone
Status: Recruiting
Pierre, South Dakota, 57501, United States
No email / No phone
Status: Recruiting
Houston, Texas, 77024, United States
No email / No phone
Status: Recruiting
Houston, Texas, 77030, United States
No email / No phone
Status: Recruiting
Houston, Texas, 77008, United States
No email / No phone
Status: Recruiting
Houston, Texas, 77098, United States
No email / No phone
Status: Recruiting
Houston, Texas, 77024, United States
No email / No phone
Status: Recruiting
Houston, Texas, 77054, United States
No email / No phone
Status: Recruiting
Houston, Texas, 77070, United States
No email / No phone
Status: Recruiting
Humble, Texas, 77338, United States
No email / No phone
Status: Recruiting
Pearland, Texas, 77584, United States
No email / No phone
Status: Recruiting
Sugar Land, Texas, 77479, United States
No email / No phone
Status: Recruiting
The Woodlands, Texas, 77380, United States
No email / No phone
Status: Recruiting
Beaumont, Texas, 77702, United States
No email / No phone
Status: Recruiting
Longview, Texas, 75601, United States
No email / No phone
Status: Recruiting
Tyler, Texas, 75702, United States
No email / No phone
Status: Recruiting
Flower Mound, Texas, 75028, United States
No email / No phone
Status: Recruiting
Denton, Texas, 76201, United States
No email / No phone
Status: Recruiting
Denison, Texas, 75020, United States
No email / No phone
Status: Recruiting
Amarillo, Texas, 79124, United States
No email / No phone
Status: Recruiting
Midland, Texas, 79701, United States
No email / No phone
Status: Recruiting
Odessa, Texas, 79761, United States
No email / No phone
Status: Recruiting
Wichita Falls, Texas, 76310, United States
No email / No phone
Status: Recruiting
El Paso, Texas, 79938, United States
No email / No phone
Status: Recruiting
El Paso, Texas, 79915, United States
No email / No phone
Status: Recruiting
El Paso, Texas, 79902, United States
No email / No phone
Status: Recruiting
Abilene, Texas, 79606, United States
No email / No phone
Status: Recruiting
Irving, Texas, 75063, United States
No email / No phone
Status: Recruiting
Irving, Texas, 75063, United States
No email / No phone
Status: Recruiting
Wytheville, Virginia, 24382, United States
No email / No phone
Status: Recruiting
Salem, Virginia, 24153, United States
No email / No phone
Status: Recruiting
Roanoke, Virginia, 24014, United States
No email / No phone
Status: Recruiting
Low Moor, Virginia, 24457, United States
No email / No phone
Status: Recruiting
Blacksburg, Virginia, 24060, United States
No email / No phone
Status: Recruiting
Woodbridge, Virginia, 22191, United States
No email / No phone
Status: Recruiting
Reston, Virginia, 20190, United States
No email / No phone
Status: Recruiting
Manassas, Virginia, 20110, United States
No email / No phone
Status: Recruiting
Fairfax, Virginia, 22031, United States
No email / No phone
Status: Recruiting
Arlington, Virginia, 22201, United States
No email / No phone
Status: Recruiting
Ghent, 9000, Belgium
No email / No phone
Status: Not yet recruiting
Charleroi, Hainaut, 6060, Belgium
No email / No phone
Status: Not yet recruiting
Brest, 29200, France
No email / No phone
Status: Not yet recruiting
Paris, 75015, France
No email / No phone
Status: Not yet recruiting
Villejuif, 94800, France
No email / No phone
Status: Not yet recruiting
Créteil, Île-de-France Region, 94000, France
No email / No phone
Status: Not yet recruiting
Hamburg, 22763, Germany
No email / No phone
Status: Not yet recruiting
Berlin, 12559, Germany
No email / No phone
Status: Not yet recruiting
Dresden, 01307, Germany
No email / No phone
Status: Not yet recruiting
Petah Tikva, HA Merkaz, 4941492, Israel
No email / No phone
Status: Not yet recruiting
Jerusalem, Jerusalem, 9112001, Israel
No email / No phone
Status: Not yet recruiting
Tel Aviv, TELL ABĪB, 6423906, Israel
No email / No phone
Status: Not yet recruiting
Tricase, Lecce, 73039, Italy
No email / No phone
Status: Not yet recruiting
Poznan, 60-192, Poland
No email / No phone
Status: Not yet recruiting
Opole, 45-061, Poland
No email / No phone
Status: Not yet recruiting
Katowice, Silesian Voivodeship, 40-519, Poland
No email / No phone
Status: Not yet recruiting
Barcelona, 08029, Spain
No email / No phone
Status: Not yet recruiting
Barcelona, 08036, Spain
No email / No phone
Status: Not yet recruiting
Málaga, 29011, Spain
No email / No phone
Status: Not yet recruiting
Córdoba, 14004, Spain
No email / No phone
Status: Not yet recruiting
Málaga, Andalusia, 29016, Spain
No email / No phone
Status: Not yet recruiting
Barcelona, Barcelona [barcelona], 08035, Spain
No email / No phone
Status: Not yet recruiting
Jerez de la Frontera, Cádiz, 11407, Spain
No email / No phone
Status: Not yet recruiting
Taoyuan District, 333, Taiwan
No email / No phone
Status: Not yet recruiting
Kaohsiung City, 83301, Taiwan
No email / No phone
Status: Not yet recruiting
Tainan, 704, Taiwan
No email / No phone
Status: Not yet recruiting
Taipei, 10002, Taiwan
No email / No phone
Status: Not yet recruiting
Taipei, 11217, Taiwan
No email / No phone
Status: Not yet recruiting
Denver, Colorado, 80218, United States
No email / No phone
Status: Not yet recruiting
Denver, Colorado, 80218, United States
No email / No phone
Status: Not yet recruiting
Denver, Colorado, 80218, United States
No email / No phone
Status: Not yet recruiting
Portland, Oregon, 97227, United States
No email / No phone
Status: Not yet recruiting
Clackamas, Oregon, 97015, United States
No email / No phone
Status: Not yet recruiting
Hillsboro, Oregon, 97124, United States
No email / No phone
Status: Not yet recruiting
Nashville, Tennessee, 37232, United States
No email / No phone
Status: Not yet recruiting
Richmond, Virginia, 23235, United States
No email / No phone
Status: Not yet recruiting
Richmond, Virginia, 23229, United States
No email / No phone
Status: Not yet recruiting
Petersburg, Virginia, 23805, United States
No email / No phone
Status: Not yet recruiting
Midlothian, Virginia, 23112, United States
No email / No phone
Status: Not yet recruiting
Mechanicsville, Virginia, 23116, United States
No email / No phone
Status: Not yet recruiting