This is a first-in-human, Phase 1/2 multi-center, open-label, dose escalation and expansion study of AO-176 which will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and clinical effects of AO-176 in patients with advanced solid tumors.
A Phase 1/2 Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AO-176
This is a first-in-human, Phase 1/2 multicenter, open-label, dose escalation and expansion study of AO-176 in patients with solid tumors. Part A of this study will examine escalating repeat doses of AO-176 monotherapy in patients with select advanced solid tumors (epithelial ovarian carcinoma, including primary peritoneal and fallopian tube carcinoma, squamous cell carcinoma of head and neck, endometrial carcinoma, castration resistant prostate cancer, non-small cell lung adenocarcinoma, papillary thyroid carcinoma, pleural or peritoneal malignant mesothelioma and gastroesophageal adenocarcinoma) for which standard therapy proven to provide clinical benefit does not exist or is no longer effective.
The study utilizes a classic 3+3 design, with enrollment of 3 patients per cohort and expansion of the cohort in the event of a dose-limiting toxicity (DLT).
Once the maximum-tolerated dose (MTD)/recommended phase 2 dose (RP2D) has been established, tumor-specific dose expansion cohorts will be recruited to further assess safety and evaluate preliminary efficacy of AO-176.