Investigational Drug
PF-08634404
TrialFetch AI Analysis
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Overview
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)
Mechanism of action
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)
Efficacy
- NSCLC, without chemotherapy: In a phase 2 study of previously untreated advanced disease with PD-L1 expression of at least 1%, the confirmed objective response rate was 67.6% among 34 patients receiving 10 mg/kg every three weeks. Median progression-free survival was 12.4 months; median overall survival had not been reached at the November 28, 2025, data cutoff. This treatment group had no comparator arm. (ascopubs.org)
- NSCLC, with chemotherapy: An early randomized phase 2 study reported confirmed response rates of 58.6% with SSGJ-707 plus chemotherapy versus 38.7% with tislelizumab plus the same chemotherapy in the nonsquamous NSCLC groups (29 and 31 patients, respectively). These small, early groups do not establish a survival advantage. (jitc.bmj.com)
- Other cancers: Early phase 2 abstracts have also reported responses with SSGJ-707 plus chemotherapy in metastatic colorectal and advanced or recurrent endometrial cancer. Because these are combination regimens, their results cannot isolate the drug’s contribution. (annalsofoncology.org)
Safety
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)
Further reading
- Updated 2026 NSCLC monotherapy results
- NSCLC plus-chemotherapy phase 2 abstract
- Endometrial cancer phase 2 abstract
Last updated: Sep 2026
Active trials using PF-08634404
Found 9 active trials using this drug:
TrialFetch AI summary: For adults with previously untreated small cell lung cancer transformed from EGFR-mutated NSCLC after tyrosine kinase inhibitor therapy, this single-arm study combines chemotherapy with PF-08634404, an investigational bispecific antibody targeting PD-1 and VEGF. Treatment is followed by PF-08634404 maintenance; the chemotherapy regimen is not specified.
ClinicalTrials.gov ID: NCT07476287
TrialFetch AI summary: Adults with previously untreated, locally advanced unresectable or metastatic RCC and ECOG performance status 0–1 receive PF-08634404 alone or with one of two anticancer combinations. PF-08634404 is an investigational bispecific antibody targeting PD-1 and VEGF.
ClinicalTrials.gov ID: NCT07227415
TrialFetch AI summary: Adults with measurable locally advanced or metastatic urothelial carcinoma and ECOG performance status 0–1 receive PF-08634404 alone if previously treated, or PF-08634404 plus enfortumab vedotin if untreated for advanced disease. PF-08634404 is an investigational bispecific antibody targeting PD-1 and VEGF.
ClinicalTrials.gov ID: NCT07421700
TrialFetch AI summary: For treatment-naïve adults with locally advanced or metastatic HER2-negative, PD-L1-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma and ECOG performance status 0–1, this study evaluates PF-08634404 plus chemotherapy against nivolumab plus chemotherapy. PF-08634404 is an investigational bispecific antibody targeting PD-1 and VEGF.
ClinicalTrials.gov ID: NCT07392892
TrialFetch AI summary: Adults with previously untreated, unresectable stage IIIB/IIIC or metastatic NSCLC and no known actionable genomic alterations receive PF-08634404, an investigational PD-1/VEGF bispecific antibody, plus either sigvotatug vedotin, an integrin β6–targeted MMAE antibody–drug conjugate, or another protocol-specified anticancer agent. The latter cohort requires PD-L1 TPS ≥1%.
ClinicalTrials.gov ID: NCT07227298
TrialFetch AI summary: Adults with previously untreated, unresectable stage IIIB/IIIC or metastatic squamous or nonsquamous NSCLC, ECOG 0–1, and no actionable alteration with an available first-line therapy receive histology-specific chemotherapy plus either PF-08634404 or pembrolizumab. PF-08634404 is an investigational bispecific antibody targeting PD-1 and VEGF; treatment continues as maintenance with the assigned antibody alone for squamous disease or with chemotherapy for nonsquamous disease.
ClinicalTrials.gov ID: NCT07222566
TrialFetch AI summary: Adults with previously untreated metastatic colorectal adenocarcinoma, ECOG 0–1, and measurable disease are eligible; key exclusions include BRAF V600E–mutant and MSI-high/dMMR disease. Participants receive chemotherapy plus either PF-08634404, an investigational bispecific antibody targeting PD-1 and VEGF, or bevacizumab.
ClinicalTrials.gov ID: NCT07222800
TrialFetch AI summary: Adults with previously untreated extensive-stage small cell lung cancer, measurable disease, and ECOG performance status 0–1 receive chemotherapy plus PF-08634404, an investigational bispecific antibody targeting PD-1 and VEGF. The randomized portion compares this regimen with atezolizumab plus chemotherapy.
ClinicalTrials.gov ID: NCT07226999
TrialFetch AI summary: Adults with previously untreated, unresectable locally advanced or metastatic HCC, ECOG 0–1, and Child-Pugh A liver function receive first-line PF-08634404 alone or with ipilimumab. PF-08634404 is an investigational PD-1/VEGF bispecific antibody; ipilimumab blocks CTLA-4.
ClinicalTrials.gov ID: NCT07227012
