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Brief Title: AO-176 in Multiple Solid Tumor Malignancies
Official Title: 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
Study ID: NCT03834948
Brief Summary: 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.
Detailed Description: 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, including epithelial ovarian carcinoma (EOC), which will include primary peritoneal and fallopian tube carcinoma; squamous cell carcinoma of the 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. Part B and Part C of this study will examine escalating repeat doses of AO-176 in combination with paclitaxel (Part B) or pembrolizumab (Part C) in platinum-resistant EOC, including primary peritoneal and fallopian tube carcinoma; endometrial carcinoma; and gastric adenocarcinoma/gastroesophageal adenocarcinoma. The monotherapy and combination dose escalation portions of the study utilize 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 in dose escalation, tumor-specific dose expansion cohorts will be recruited to further assess safety and evaluate preliminary efficacy of AO-176 as monotherapy, in combination with paclitaxel, and in combination with pembrolizumab.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Southern California, Los Angeles, California, United States
University of California San Francisco, San Francisco, California, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Oklahoma University, Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Oregon Health Science University, Portland, Oregon, United States
Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Tennessee Oncology, Nashville, Tennessee, United States
University of Virginia, Charlottesville, Virginia, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Northwest Medical Specialties, Tacoma, Washington, United States
Name: Benajmin Oshrine, MD
Affiliation: Arch Oncology
Role: STUDY_DIRECTOR