A Phase Ib/II Study of Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced Solid Tumors
OHSU Knight Cancer Institute
Summary
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.
Description
PRIMARY OBJECTIVES: I. Phase Ib: Determine the safety and tolerability of the combination of axatilimab, retifanlimab, and paclitaxel in patients with advanced solid tumors. II. Phase II: Determine the efficacy of the combination of axatilimab, retifanlimab, and paclitaxel in patients with advanced solid tumors. SECONDARY OBJECTIVES: I. Determine the safety and tolerability of the combination of axatilimab, retifanlimab, and paclitaxel in patients with advanced solid tumors treated in phase II. II. Explore treatment related changes in the tumor microenvironment (TME) following treatment w…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Ability to comprehend the investigational nature of the study and provide informed consent. Written informed consent must be obtained prior to any study specific procedures or interventions * Age ≥ 18 years at the time of consent. All participants, irrespective of their gender, gender identity, race, and ethnicity, will be included * Certified, documented diagnosis of a metastatic solid tumor based on pathology review * Presence of at least one lesion that is measurable per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and another lesion that is amenable to t…
Interventions
- BiologicalAxatilimab
Given IV
- ProcedureBiopsy
Undergo tumor biopsy
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureComputed Tomography
Undergo CT scan
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- DrugPaclitaxel
Given IV
- ProcedurePositron Emission Tomography
Undergo PET scan
Location
- OHSU Knight Cancer InstitutePortland, Oregon