Status:
COMPLETED
AO-176 in Multiple Solid Tumor Malignancies
Lead Sponsor:
Arch Oncology
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 c...
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 A...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2023
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT03834948
Start Date
February 4 2019
End Date
February 15 2023
Last Update
August 22 2023
Active Locations (10)
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1
University of Southern California
Los Angeles, California, United States, 90033
2
University of California San Francisco
San Francisco, California, United States, 94143
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215-5450
4
Oklahoma University, Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104