Condition: Solid Tumor · Sponsor: Arch Oncology
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.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
Key Inclusion Criteria 1. Select advanced solid tumor for which standard therapy proven to provide clinical benefit does not exist, or is no longer effective Part A: * Epithelial ovarian carcinoma (EOC) * Endometrial carcinoma * Castration resistant prostate cancer * Non-small cell lung adenocarcinoma * Papillary thyroid carcinoma * Malignant mesothelioma (pleural or peritoneal) * Gastroesophageal adenocarcinoma * Squamous cell carcinoma of the head and neck Part B and Part C: * Platinum-resistant EOC (including fallopian tube or primary peritoneal cancer) * Endometrial carcinoma * Gastric adenocarcinoma/gastroesophageal adenocarcinoma 2. Measurable disease 3. ECOG status 0-1 4. Resolution of prior-therapy-related adverse effects 5. Minimum of 4 weeks or 5 half-lives since last dose of cancer therapy Key Exclusion Criteria: 1. Previous hypersensitivity reaction to treatment with another monoclonal antibody 2. Unresolved hypersensitivity to paclitaxel or any of its excipients (Part B only). Patients who have been desensitized may participate. 3. Part C Only 1. History of interstitial lung disease or a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. 2. History of immune mediated colitis, hepatitis, endocrinopathies, nephritis or significant immune mediated skin reactions such as toxic epidermal necrolitis or Stevens -Johnson Syndrome 3. History of any autoimmune disease which required systemic therapy\* in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs) including but not limited to: i. Inflammatory bowel disease (including ulcerative colitis and Crohn's Disease) ii. Rheumatoid arthritis iii. Systemic progressive sclerosis (scleroderma) iv. Systemic lupus erythematosus v. Autoimmune vasculitis (e.g. Wegener's granulomatosis) \*Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed) 4. Prior treatment with a checkpoint inhibitor (anti-PD-1, PD-L1, CTLA-4 etc.) within 4 weeks prior to the start of study drug 5. Prior treatment with a CD47-targeted therapy 6. Prior organ or stem cell transplant
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| 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 | — |
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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