Actively Recruiting
A Phase Ib/II Study of Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced Solid Tumors
Led by OHSU Knight Cancer Institute · Updated on 2025-12-29
38
Participants Needed
1
Research Sites
104 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
Researchers are evaluating the safety, side effects, and effectiveness of combining axatilimab, retifanlimab, and paclitaxel to treat patients with advanced or metastatic solid tumors. This phase I/II trial focuses on tumors that have spread from their original site to nearby tissues, lymph nodes, or distant body parts. Axatilimab is a monoclonal antibody that may prevent tumor growth and spread, while retifanlimab aims to help the immune system attack cancer cells. Paclitaxel is a medication that stops cancer cells from growing and dividing. Participants receive axatilimab intravenously over 30 minutes on day -8 before cycle 1 starts. From cycle 1 day 1, axatilimab is given on days 8 and 22 of each 28-day cycle, retifanlimab is given on day 1, and paclitaxel is given on days 1, 8, and 15. These cycles continue unless the disease worsens or side effects become unacceptable. During the study, patients may have tumor biopsies, CT scans, blood tests, and possibly MRI or PET scans. After completing treatment, patients have follow-up visits at 30 and 90 days. Throughout the trial, researchers monitor treatment safety, side effects, changes in immune cells, and clinical benefits such as tumor response. The trial uses various assessments, including imaging and blood tests, to evaluate how patients respond to the combination therapy and to explore biomarkers related to treatment effects.
CONDITIONS
Brief 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...
- Ability to understand the study and provide written informed consent
- Age 18 years or older at consent
- Documented metastatic solid tumor diagnosis confirmed by pathology
- At least one measurable lesion per RECIST 1.1 and another lesion suitable for biopsy
- Relapsed or refractory to standard systemic therapy that prolongs survival or best option is a clinical trial
- Prior investigational therapy stopped at least 28 days or 5 half-lives before study day -8
- Prior taxane treatment with at least 3 months washout before day -8
- ECOG performance status of 0 or 1
- Life expectancy greater than 12 weeks
- Hemoglobin ≥ 8.5 g/dL
- Leukocytes ≥ 3,000/mcL
- Absolute neutrophil count ≥ 1,500/mcL
- Platelets ≥ 100,000/mcL without recent transfusion
- Serum creatinine < 1.5 x ULN or creatinine clearance ≥ 50 mL/min
- Total bilirubin < 1.5 x ULN (exceptions apply)
- AST or ALT ≤ 2.5 x ULN
- Cardiac function assessed as NYHA class 2B or better if history of cardiac disease
- QTcF < 480 ms on 12-lead EKG (exceptions apply)
- Willingness to adjust medications affecting CYP2C8 and CYP3A4
- Maintenance corticosteroid doses ≤ 10 mg/day prednisone or equivalent allowed
- CD4+ T-cell count ≥ 350 cells/uL regardless of HIV status
- Controlled HIV with undetectable viral load allowed
- Evidence of resolved or controlled hepatitis B or C infection allowed
You will not qualify if you...
- Secondary malignancy diagnosed less than 3 years before study day -8
- New or progressive brain metastases requiring immediate treatment; active leptomeningeal disease
- Palliative radiation therapy within 1 week before study day -8
- Live vaccine within 28 days before study day -8
- History of organ transplantation including stem cell transplant
- Interstitial lung disease or active non-infectious pneumonia
- Active autoimmune disease requiring systemic immunosuppression above maintenance corticosteroids
- Prior grade 3 or higher immune-related adverse event needing systemic immunosuppression
- Unresolved toxicities from prior cancer therapies except certain mild conditions
- Allergy or severe reaction to study drugs or their components
- Active infection needing systemic antibiotics
- Pregnancy or breastfeeding; requirement for effective contraception during and up to months after treatment
- Uncontrolled illness or psychiatric/social conditions limiting study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 days
Participants receive a single dose of axatilimab intravenously 8 days before starting the main treatment cycles.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or unacceptable toxicity
Participants receive axatilimab, retifanlimab, and paclitaxel intravenously in repeating 28-day cycles. Treatment continues in the absence of disease progression or unacceptable toxicity. Participants undergo tumor biopsies, CT scans, and blood sample collections throughout treatment. MRI and PET scans may also be performed during this time.
Multiple visits each cycle including dosing on days 1, 8, 15, and 22 with assessments throughout
Duration - Approximately 3 months
After completing treatment, participants are followed up to monitor safety and health status.
2 visits at 30 and 90 days post-treatment
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here