Actively Recruiting
Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced or Metastatic Solid Tumors
Led by OHSU Knight Cancer Institute · Updated on 2025-12-29
38
Participants Needed
1
Research Sites
253 weeks
Total Duration
On this page
Sponsors
O
OHSU Knight Cancer Institute
Lead Sponsor
O
Oregon Health and Science University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I/II trial tests the safety, side effects, and effectiveness of axatilimab in combination with retifanlimab and paclitaxel for the treatment of patients with a solid tumor that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Axatilimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Giving axatilimab in combination with retifanlimab and paclitaxel may be safe, tolerable and/or effective in treating patients with advanced or metastatic solid tumors.
CONDITIONS
Official Title
Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand the study and provide written informed consent before any study procedures
- Age 18 years or older at the time of consent
- Confirmed diagnosis of metastatic solid tumor by pathology review
- At least one measurable tumor lesion and another lesion suitable for biopsy
- Relapsed or refractory to standard systemic therapy or clinical trial considered best next option
- Completed wash-out period of 5 half-lives or 28 days from prior investigational therapies before study day -8
- Prior taxane treatment with at least 3 months wash-out before study day -8
- ECOG performance status of 0 or 1
- Life expectancy greater than 12 weeks
- Hemoglobin level 8.5 g/dL or higher
- Leukocyte count 3,000/mcL or higher
- Absolute neutrophil count 1,500/mcL or higher
- Platelet count 100,000/mcL or higher, without recent transfusion
- Serum creatinine less than 1.5 times upper limit of normal or creatinine clearance 50 mL/min or higher
- Total bilirubin less than 1.5 times upper limit of normal (exceptions allowed)
- AST or ALT levels 2.5 times upper limit of normal or lower
- Cardiac function classified as New York Heart Association class 2B or better if history of cardiac disease
- Corrected QT interval less than 480 ms on EKG (except some exceptions)
- Willing to adjust medications as recommended by pharmacy services
- Maintenance corticosteroid doses of 10 mg/day prednisone equivalent or less allowed
- CD4+ T-cell count 350 cells/uL or higher regardless of HIV status
- HIV-positive patients must have undetectable viral load within 6 months
- Chronic hepatitis B infection with controlled status or resolved prior infection permitted
- History of hepatitis C infection permitted if prior curative treatment or undetectable viral load
You will not qualify if you...
- Secondary cancer diagnosed less than 3 years before study day -8
- New or progressive brain metastases, except stable for at least 4 weeks without symptoms
- Active leptomeningeal disease
- Palliative radiation therapy within 1 week before study day -8 or unresolved radiation toxicities
- Live vaccine received within 28 days before study day -8
- History of organ or stem cell transplantation
- Signs of interstitial lung disease or active non-infectious pneumonia
- Active autoimmune disease needing systemic immunosuppression beyond maintenance corticosteroids
- Prior severe immune-related adverse events requiring systemic immunosuppression
- Unresolved toxicities from prior cancer treatment except specified mild conditions
- Allergy or severe reaction to study drugs or their components
- Active infections needing systemic antibiotics
- Pregnant or breastfeeding persons of childbearing potential
- Uncontrolled illness or psychiatric/social conditions limiting study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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