Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced or Metastatic Solid Tumors
A Phase Ib/II Study of Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced Solid Tumors
2 other identifiers
interventional
38
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2024
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2024
CompletedFirst Posted
Study publicly available on registry
March 20, 2024
CompletedStudy Start
First participant enrolled
May 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2029
December 29, 2025
December 1, 2025
2.9 years
March 5, 2024
December 25, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Incidence of dose limiting toxicities (phase Ib)
Will be coded by system organ class, MedDRA preferred term, and severity grade using Common Terminology Criteria for Adverse Events (version 5.0).
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])
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)
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.
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])
Secondary Outcomes (3)
Incidence of ≥ grade 3 toxicities possibly or definitely related to study drugs
From the first dose of axatilimab (day -8) to 90 days after the end of treatment visit (an average of 6 months)
Changes in immune cell composition and functionality
From screening until cycle 2 day 1 biopsy (each cycle is 28 days starting from cycle 1 day 1 [first dose of retifanlimab and paclitaxel])
Change in immune cell population
From screening to end of treatment visit (an average of 6 months)
Study Arms (1)
Treatment (axatilimab, retifanlimab, paclitaxel)
EXPERIMENTALPatients receive axatilimab IV over 30 minutes on day -8, prior to cycle 1. Beginning in cycle 1 day 1, patients receive axatilimab IV over 30 minutes on days 8 and 21 of each cycle, retifanlimab IV over 30-60 minutes on day 1 of each cycle, and paclitaxel IV over 60 minutes on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo tumor biopsy, CT scan, and blood sample collection throughout the study and may undergo MRI and/or PET scan throughout the study.
Interventions
Undergo PET scan
Given IV
Given IV
Undergo tumor biopsy
Undergo blood sample collection
Undergo CT scan
Undergo MRI
Given IV
Eligibility Criteria
You may qualify if:
- 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
- +13 more criteria
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OHSU Knight Cancer Institutelead
- Incyte Corporationcollaborator
- Oregon Health and Science Universitycollaborator
Study Sites (1)
OHSU Knight Cancer Institute
Portland, Oregon, 97239, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shivaani Kummar
OHSU Knight Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 5, 2024
First Posted
March 20, 2024
Study Start
May 21, 2024
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2029
Last Updated
December 29, 2025
Record last verified: 2025-12