Axatilimab, Retifanlimab, and Paclitaxel for Advanced Solid Tumors
This study is testing a combination of three medicines: axatilimab, retifanlimab, and paclitaxel, for people with advanced or metastatic (spread to other parts of the body) solid tumors. Axatilimab and retifanlimab are monoclonal antibodies (a type of immunotherapy that helps your immune system fight cancer), and paclitaxel is a chemotherapy drug. Researchers want to see how safe this combination is, what side effects it causes, and how well it works to shrink tumors. You might be able to join if you are 18 or older and have certain types of advanced solid tumors. The study is currently recruiting about 38 participants.
- Study design
- This is a Phase I/II interventional study, meaning it tests the safety and effectiveness of the drug combination. It plans to enroll about 38 participants.
- What's involved
- You would receive axatilimab, retifanlimab, and paclitaxel intravenously (through a vein) on specific days in 28-day cycles. You would also undergo tumor biopsies, blood sample collections, CT scans, and MRIs.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will assess clinical benefit from screening until the end of cycle 6 (each cycle is 28 days).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06320405
Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced or Metastatic Solid Tumors
Recruiting
PHASE1Ages 18+InterventionalTreatmentOHSU Knight Cancer InstituteInvestigator-initiated
~38 participants
Updated 2026-07-08 on ClinicalTrials.gov
What's tested:AxatilimabBiopsyBiospecimen CollectionComputed TomographyMagnetic Resonance ImagingPaclitaxel
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of dose limiting toxicities (phase Ib)
Measured over From the first dose of axatilimab (day -8) to the end of cycle 1 (cycle is 28 days starting from cycle 1 day 1 [first dose of retifanlimab and paclitaxel])
+2 more outcomes measured
Conditions
NCT06320405
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
OHSU Knight Cancer Institute
Portland, Oregonstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Shivaani Kummar · PRINCIPAL_INVESTIGATOR · OHSU Knight Cancer Institute
Who to contact
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Eligibility criteria
Inclusion
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 tumor biopsy
Relapsed from, or refractory to, standard of care (SOC) systemic therapy known to prolong survival or if, in the opinion of the primary treating oncologist, a clinical trial is the best option for the next line of treatment based on response and/or tolerability to available therapies
Investigational therapy is permitted after a wash-out period of 5 half-lives (if known), or 28 days, whichever is shorter, prior to study day -8. Prior use of an investigational agent for imaging, such as T cell imaging, is permitted
Prior treatment with taxanes. A wash-out of period of ≥ 3 months prior to day -8 must be met for enrollment. Prior anti PD-1/PD-L1 therapy is allowed, but not required
Eastern Cooperative Oncology Group (ECOG) status (performance status \[PS\]) of 0-1
Life expectancy of greater than 12 weeks according to certified physician review
Hemoglobin (Hb) ≥ 8.5 g/dL
Leukocytes ≥ 3,000/mcL
Absolute neutrophil count (ANC) ≥ 1,500/mcL
Platelets ≥ 100K/cc mL
Values must be obtained without transfusion within 2 weeks
Serum creatinine (sCr) \< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) ≥ 50 mL/min (calculated with the Cockcroft-Gault formula) for participants with creatinine (sCr) levels above institutional normal
Total bilirubin \< 1.5 x upper limit of normal (ULN)
With the exception of documented Gilbert's syndrome or similar conditions, at the discretion of the principal investigator (PI). Clinical chemistry testing may be adjusted, as clinically indicated
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) or alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 2.5 x ULN
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association (NYHA) Functional Classification. To be eligible for this trial, patients should be class 2B or better
Corrected QT interval Fridericia's formula (QTcF) of \< 480 ms on a 12 lead electrocardiogram (EKG), except for participants with atrioventricular pacemakers or other conditions (e.g., right bundle branch block) that render the QT measurement invalid
Willingness to modify concomitant drug regimens, at the recommendation and discretion of pharmacy services, including the use of known substrates or inhibitors of CYP2C8 and CYP3A4
Physiologic maintenance doses of corticosteroids (≤ 10 mg/day of prednisone or equivalent) are permitted. Examples include: Asthma treatment; topical ocular, intra-articular, or intranasal steroids with minimal systemic absorption; and brief courses of corticosteroids for prophylaxis
Patients with CD4+ T-cell (CD4+) counts ≥ 350 cells/uL are eligible regardless of HIV serology
HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of enrollment are eligible
In the case of ongoing treatment with antiretroviral therapy (ART), medication adjustment may be necessary for the duration of treatment. A wash-out period may be necessary, at the recommendation of the institutional research pharmacy service (RPS)
Evidence of chronic hepatitis B virus (HBV) infection (i.e., hepatitis B surface antigen \[HBsAg\]-positive, undetectable or low HBV deoxyribonucleic acid \[DNA\], and normal ALT) in the absence of HBV therapy, or serologic evidence of a resolved prior HBV infection (i.e., HBsAg-negative and hepatitis B virus core antibody \[anti-HBc\]-positive) is permitted
History of hepatitis C virus (HCV) infection is permitted given prior curative treatment or undetectable HCV viral load by serology or polymerase chain reaction (PCR) testing
Patient who are HCV antibody (Ab) seropositive but HCV ribonucleic acid (RNA) negative due to prior treatment or natural resolution are eligible
Exclusion
Secondary malignancy with documented diagnosis by a treating physician \< 3 years prior to study day -8. The following criteria also apply:
New or progressive brain metastases. Patients with brain metastases not requiring immediate central nervous system (CNS) specific treatment or stable for at least 4 weeks prior to study day -8 are eligible at the discretion of the investigator given that neurologic symptoms are resolved.
Patients with active leptomeningeal disease are not eligible
Palliative radiation therapy administered within 1 week prior to study day -8, Note: Participants must have recovered from all radiation-related toxicities (to grade \< 1 or baseline), must not require corticosteroids for this purpose, and must not have had radiation pneumonitis
Immunization with a live vaccine within 28 days prior to study day -8
History of organ transplantation, including hematopoietic stem cell transplantation (HSCT)
Clinical evidence of interstitial lung disease or active non-infectious pneumonia
Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (≤ 10 mg/day of prednisone or equivalent is permitted)
Prior National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 immune-related adverse event (irAE) that required systemic immunosuppression (endocrinopathies managed by stable doses of supplements and/or corticosteroids ≤ 10 mg/day are permitted)
Unresolved toxicities (resolution required to grade 1 or baseline) from prior anticancer therapies. The following exceptions apply:
Alopecia, lymphopenia, grade 2 neuropathy (if not resulting in functional deficit), and grade 1 (no supplementation required) or grade 2 endocrinopathies (stable on supplements)
Prior allergy or severe hypersensitivity reaction to axatilimab, retifanlimab, paclitaxel, cremaphor-containing agents, and/or components of the drug formulations
Active infection requiring systemic antibiotic therapy
Persons of childbearing potential (PCBP) who are pregnant (i.e., positive pregnancy test within 7 days prior to study day -8) or breastfeeding are not eligible.
The effects of the investigational regimen on the developing human fetus are unknown. For this reason, persons of reproductive potential must agree to use a highly effective form of contraception, starting with the time of consent to 4 months after the last dose of retifanlimab or 90 days after the last dose of axatilimab, whichever is longer
Sperm-producing participants must not donate sperm throughout the study period and for 90 days post completion of study treatment
Uncontrolled, intercurrent illness and psychiatric illness/social situations that would limit compliance with study requirements, at the discretion of the investigator
What this trial measures
- Incidence of dose limiting toxicities (phase Ib)From the first dose of axatilimab (day -8) to the end of cycle 1 (cycle is 28 days starting from cycle 1 day 1 [first dose of retifanlimab and paclitaxel])
Will be coded by system organ class, MedDRA preferred term, and severity grade using Common Terminology Criteria for Adverse Events (version 5.0).
- Recommended phase 2 dose of the study drug combination (phase Ib)From the first dose of axatilimab (day -8) to the end of cycle 1 (cycle is 28 days starting from cycle 1 day 1 [first dose of retifanlimab and paclitaxel])
- Clinical benefit rate (phase Ib/II)From screening assessment to the end of cycle 6 assessment (each cycle is 28 days starting from cycle 1 day 1 [first dose of retifanlimab and paclitaxel])
Defined as percentage of participants with complete response or partial response confirmed by scans at least 4 weeks apart, or stable disease for \> 4 months. Will be reported with exact 95% confidence interval.