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
Inclusion and Exclusion Criteria
- Key Inclusion Criteria
- 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
- Measurable disease
- ECOG status 0-1
- Resolution of prior-therapy-related adverse effects
- Minimum of 4 weeks or 5 half-lives since last dose of cancer therapy Key Exclusion Criteria:
- Previous hypersensitivity reaction to treatment with another monoclonal antibody
- Unresolved hypersensitivity to paclitaxel or any of its excipients (Part B only). Patients who have been desensitized may participate.
- Part C Only
- History of interstitial lung disease or a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- History of immune mediated colitis, hepatitis, endocrinopathies, nephritis or significant immune mediated skin reactions such as toxic epidermal necrolitis or Stevens -Johnson Syndrome
- 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)
- Prior treatment with a checkpoint inhibitor (anti-PD-1, PD-L1, CTLA-4 etc.) within 4 weeks prior to the start of study drug
- Prior treatment with a CD47-targeted therapy
- Prior organ or stem cell transplant
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.