Sutro Biopharma Initiates Phase 1 Trial of STRO-004, Next-Generation Tissue Factor ADC for Advanced Solid Tumors
核心洞察
Sutro Biopharma has dosed the first cohort of patients in a Phase 1 trial evaluating STRO-004, a next-generation antibody-drug conjugate targeting tissue factor in advanced solid tumors.
The trial will assess STRO-004's safety and preliminary anti-tumor activity across multiple cancer types including non-small cell lung cancer, pancreatic adenocarcinoma, and colorectal cancer.
STRO-004 features an innovative design with a drug-to-antibody ratio of 8 and demonstrated higher exposure compared to approved therapies in preclinical studies.
Sutro Biopharma has announced the dosing of the first cohort of patients in a Phase 1 clinical trial evaluating STRO-004, a next-generation antibody-drug conjugate (ADC) targeting tissue factor (TF) in patients with advanced solid tumors. The milestone represents a significant step forward for the clinical-stage oncology company's proprietary cell-free platform technology.
Novel ADC Design Targets Multiple Cancer Types
STRO-004 is engineered as a TF-targeting exatecan ADC designed for enhanced stability, potency, and tumor selectivity. The Phase 1 open-label, multicenter trial will evaluate the safety, pharmacokinetics, and preliminary anti-tumor activity of STRO-004 in patients with advanced TF-expressing solid tumors, including non-small cell lung cancer, head and neck squamous cell carcinoma, cervical cancer, colorectal cancer, pancreatic ductal adenocarcinoma, and bladder cancer.
"Dosing the initial patients in this trial marks an important milestone in bringing forward new treatment options for patients with TF–expressing cancers—many of whom face limited therapy options and difficult prognoses," said Jane Chung, Chief Executive Officer of Sutro Biopharma. "STRO-004 is engineered to deliver potent, sustained anti-tumor activity and higher exposure compared to approved therapies, with the goal of reaching tumors that are resistant to standard approaches."
Innovative Platform Technology
STRO-004 features an Fc-silent, high affinity antibody with site-specific β-glucuronidase cleavable linker and exatecan payload at a drug-to-antibody ratio of 8 (DAR8). This design aims to enhance stability, reduce off-target toxicity, and maximize efficacy. In preclinical studies, STRO-004 demonstrated robust anti-tumor activity, favorable tolerability, and higher exposure compared to approved therapies.
The dose-escalation phase includes multiple cohorts with ascending dose levels, supported by strong tolerability in non-human primates at up to 50 mg/kg. Sutro's design enables high entry doses, with the goal of rapidly identifying a recommended Phase 2 dose and early signs of clinical activity.
Clinical Development Timeline
The company expects to share initial clinical data from the trial in mid-2026. The study design focuses on generating early insights into safety and activity that will guide development in areas of urgent unmet need.
Sutro Biopharma's cell-free platform produces ADCs that are engineered to improve drug exposure, reduce side effects, and expand the range of treatable tumor types. The company's pipeline of single- and dual-payload ADCs targets large oncology markets with limited treatment options and significant need for improved therapies.