Sponsor: Pfizer (industry)
Phase: 3
Start date: Dec. 11, 2025
Planned enrollment: 800
PF-08634404 (also referred to as SSGJ-707) is an investigational PD-1/VEGF bispecific antibody being developed for multiple solid tumors, including non-small cell lung cancer (NSCLC) and metastatic colorectal cancer (mCRC). Clinical development has included Phase 2 studies in China (under the SSGJ-707 name) and Pfizer-sponsored global studies (under the PF-08634404 code).
Sources: ClinicalTrials.gov: NCT07222566, JITC abstract (2025 supplement)
First-line advanced NSCLC (SSGJ-707 + platinum-based chemotherapy; Phase 2, NCT06412471; data cutoff July 4, 2025)
Confirmed objective response rate (ORR) reported for the SSGJ-707 10 mg/kg Q3W regimen:
- Nonsquamous NSCLC: ORR 58.6%
- Squamous NSCLC (cohort A): ORR 75.0%
- Squamous NSCLC (cohort B): ORR 69.2% with carboplatin + nab-paclitaxel; 37.5% with carboplatin + paclitaxel (noted as majority pending confirmation in the abstract)
Comparator arm (tislelizumab + chemotherapy) confirmed ORR:
- Nonsquamous: 38.7%
- Squamous: 47.6%
Source: JITC abstract (2025 supplement)
First-line advanced NSCLC (SSGJ-707 monotherapy; Phase 2, NCT06361927; interim results as of Jan 10, 2025)
In patients with treatment-naïve advanced NSCLC and PD-L1 expression ≥1%, the abstract reports (among evaluable patients) an ORR of:
- 61.8% and disease control rate (DCR) 97.1% at 10 mg/kg Q3W (dose group sizes and evaluable counts are described in the abstract).
Source: JCO (ASCO 2025) abstract record (ResearchGate mirror), DOI: 10.1200/JCO.2025.43.16_suppl.8543
mCRC (SSGJ-707; Phase 2 trial registered; results not posted in the registry record)
A Phase 2 study evaluating first-line mCRC regimens including SSGJ-707 is registered, but no outcome results are posted in the record at this time.
Source: ClinicalTrials.gov: NCT06493760
First-line advanced NSCLC (SSGJ-707 + chemotherapy; Phase 2, NCT06412471; data cutoff July 4, 2025)
For the SSGJ-707 10 mg/kg arms across study parts:
- Grade ≥3 treatment-related adverse events (TRAEs): 39.0% (vs 32.8% with tislelizumab + chemotherapy)
- TRAEs led to treatment discontinuation in 1.9% (2 patients)
- TRAEs associated with death in 2.9% (3 patients; hemoptysis in 2; unknown cause in 1)
Source: JITC abstract (2025 supplement)
Global Phase 3 (Pfizer): PF-08634404 + chemotherapy vs pembrolizumab + chemotherapy in locally advanced/metastatic NSCLC (planned enrollment 1500; not yet recruiting as of last update posted Oct 30, 2025).
Source: ClinicalTrials.gov: NCT07222566
Phase 2 (China): SSGJ-707 in first-line mCRC (includes combination arms; no posted results)
Source: ClinicalTrials.gov: NCT06493760
Last updated: Jan 2026
Goal: To determine whether adding the investigational PD-1/VEGF bispecific antibody PF-08634404 to standard first-line chemotherapy improves clinical outcomes versus bevacizumab plus the same chemotherapy in previously untreated metastatic colorectal cancer, while characterizing safety, pharmacokinetics, immunogenicity, and patient-reported quality of life.
Patients: Adults (≥18 years) with histologically/cytologically confirmed metastatic (stage IV) colorectal adenocarcinoma, ECOG performance status 0–1, at least one RECIST 1.1 measurable lesion, and adequate organ function. Key exclusions include locally confirmed BRAF V600E mutation, MSI-high/dMMR disease, active symptomatic CNS metastases, significant bleeding risk or recent grade ≥3 hemorrhage, recent major surgery/trauma, significant cardiovascular disease within 6 months, active autoimmune disease requiring systemic therapy within 2 years, and noninfectious/drug-induced ILD/pneumonitis.
Design: Phase 3, double-blind, randomized, active-controlled, multicenter study with planned enrollment of approximately 800 participants. Treatment is delivered in repeating IV cycles and may continue until disease progression, unacceptable toxicity, or discontinuation. Disease assessments include blinded independent central review (BICR) for key efficacy endpoints, with long-term follow-up for survival and subsequent therapy outcomes (overall follow-up up to ~4 years).
Treatments: Experimental arm: PF-08634404 administered intravenously in combination with standard chemotherapy for metastatic colorectal cancer (specific regimen not provided in the trial description). PF-08634404 (also known as SSGJ-707) is a bispecific antibody targeting PD-1 and VEGF, intended to couple immune checkpoint inhibition with anti-angiogenic effects. Early-phase experience has been reported mainly in first-line NSCLC, where combination with platinum chemotherapy showed higher objective response rates than a PD-1 inhibitor plus chemotherapy in a phase 2 report, with grade ≥3 treatment-related adverse events in the ~40% range; efficacy and safety in mCRC remain investigational and are being tested here against an established anti-VEGF standard. Comparator arm: bevacizumab (anti-VEGF monoclonal antibody) administered intravenously in combination with standard chemotherapy.
Outcomes: Co-primary endpoints are progression-free survival by BICR per RECIST 1.1 and overall survival. Key secondary endpoints include objective response rate and duration of response (each assessed by BICR and by investigator), investigator-assessed PFS, PFS2 (time to second progression after next-line therapy), treatment-emergent adverse events/serious adverse events, clinical laboratory abnormalities, pharmacokinetics of PF-08634404, anti-drug antibodies, and patient-reported outcomes (EORTC QLQ-C30 global health status/QoL, EORTC QLQ-CR29 symptom/function scales, and time to definitive deterioration).
Burden on patient: Moderate burden. Treatment requires regular on-site IV infusions consistent with standard first-line mCRC therapy, plus protocol-mandated efficacy imaging and assessments over a prolonged period (up to approximately 4 years) with blinded central review. Additional study-specific procedures include pharmacokinetic sampling and immunogenicity testing (anti-drug antibodies) over roughly the first 21 months, routine safety labs, and repeated quality-of-life questionnaires; follow-up continues every 12 weeks after treatment discontinuation, which adds ongoing visits or contact beyond typical care in some settings. No mandatory biopsies are described in the provided information.
Last updated: Jan 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