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Spots Global Cancer Trial Database for AO-176 in Multiple Solid Tumor Malignancies

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Trial Identification

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

Conditions

Solid Tumor

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Benajmin Oshrine, MD

Affiliation: Arch Oncology

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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