AO-176 in Multiple Solid Tumor Malignancies

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arch Oncology
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Paclitaxel; Pembrolizumab

Criteria

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