OncoMatch/Clinical Trials/NCT06320405
Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced or Metastatic Solid Tumors
Is NCT06320405 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Axatilimab and Retifanlimab for advanced malignant solid neoplasm.
Treatment: Axatilimab · Paclitaxel · Retifanlimab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: taxane
Prior treatment with taxanes. A wash-out of period of ≥ 3 months prior to day -8 must be met for enrollment.
Cannot have received: axatilimab (axatilimab)
Prior allergy or severe hypersensitivity reaction to axatilimab
Cannot have received: retifanlimab (retifanlimab)
Prior allergy or severe hypersensitivity reaction to retifanlimab
Cannot have received: taxane (paclitaxel)
Prior allergy or severe hypersensitivity reaction to paclitaxel
Cannot have received: cremaphor-containing agents
Prior allergy or severe hypersensitivity reaction to cremaphor-containing agents
Lab requirements
Blood counts
Hemoglobin ≥ 8.5 g/dL; Leukocytes ≥ 3,000/mcL; ANC ≥ 1,500/mcL; Platelets ≥ 100K/cc mL (values must be obtained without transfusion within 2 weeks)
Kidney function
Serum creatinine < 1.5 x ULN or CrCl ≥ 50 mL/min (Cockcroft-Gault)
Liver function
Total bilirubin < 1.5 x ULN (except Gilbert's syndrome at PI discretion); AST or ALT ≤ 2.5 x ULN
Cardiac function
NYHA class 2B or better; QTcF < 480 ms (except for pacemaker or other invalidating conditions)
Hemoglobin (Hb) ≥ 8.5 g/dL; Leukocytes ≥ 3,000/mcL; Absolute neutrophil count (ANC) ≥ 1,500/mcL; Platelets ≥ 100K/cc mL; Serum creatinine (sCr) < 1.5 x ULN or creatinine clearance (CrCl) ≥ 50 mL/min (Cockcroft-Gault); Total bilirubin < 1.5 x ULN (except Gilbert's syndrome at PI discretion); AST or ALT ≤ 2.5 x ULN; NYHA class 2B or better; QTcF < 480 ms (except for pacemaker or other invalidating conditions)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- OHSU Knight Cancer Institute · Portland, Oregon
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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