On December 3, 2025 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported that the patients in the first cohort have been dosed in its Phase 1 trial evaluating STRO-004 in a range of Tissue Factor (TF) expressing solid tumors. STRO-004 is the Company’s TF-targeting exatecan ADC engineered for best-in-class stability, potency, and tumor selectivity using Sutro’s proprietary cell-free platform.
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"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. We’ve seen strong engagement from our clinical investigators, who recognize the potential of STRO-004 to address a pressing need in oncology—and we’re proud of the speed and precision with which our team brought the program into the clinic," 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. Through this trial, we aim to generate early insights into safety and activity that will guide development in areas of urgent unmet need. We are deeply grateful to the patients and investigators participating in this study and look forward to sharing initial data in mid-2026."
The Phase 1 open-label, multicenter trial is designed to 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. 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.
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About STRO-004
STRO-004 is a next-generation antibody-drug conjugate (ADC) targeting tissue factor (TF), a clinically validated tumor-associated antigen expressed across multiple solid tumors. In preclinical studies, STRO-004 demonstrated robust anti-tumor activity, favorable tolerability, and higher exposure compared to approved therapies. Developed using Sutro Biopharma’s proprietary cell-free platform, 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. It is currently being evaluated in a Phase 1 trial in patients with a range of TF-expressing solid tumors.
(Press release, Sutro Biopharma, DEC 3, 2025, https://ir.sutrobio.com/news-events/news-releases/detail/224/sutro-biopharma-announces-first-cohort-of-patients-dosed-in-phase-1-trial-of-stro-004-a-next-generation-tissue-factor-adc-in-tf-expressing-solid-tumors [SID1234661110])