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Advanced Malignant Solid NeoplasmPhase 1/2NCT06320405

Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced or Metastatic Solid Tumors

A Phase 1/2 study testing Axatilimab, Biopsy and Biospecimen Collection in people with Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, run by OHSU Knight Cancer Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Axatilimab, Biopsy and Biospecimen Collection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteUnited States
Study dates
21 May 2024to 1 Apr 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97239

    Shivaani Kummar, 503-494-6594, kummar@ohsu.edu

    Shivaani Kummar

    Recruiting

Other trials in United States

About this study

Official title: A Phase Ib/II Study of Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced Solid Tumors

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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 with the combination of axatilimab, retifanlimab, and paclitaxel in advanced solid tumors.

III. Assess predictive biomarkers of response in peripheral blood.

OUTLINE:

Patients receive axatilimab intravenously (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 22 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, computed tomography (CT) scan, and blood sample collection throughout the study and may undergo magnetic resonance imaging (MRI) and/or positron emission tomography (PET) scan throughout the study.

After completion of study treatment, patients are followed up at 30 and 90 days.

Being tested
Axatilimab, Biopsy, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AxatilimabBiological

    Also called Anti-M-CSFR Monoclonal Antibody SNDX-6352, SNDX 6352, SNDX-6352, SNDX6352

    Given IV

  • BiopsyProcedure or surgery

    Also called BIOPSY_TYPE, Bx

    Undergo tumor biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT scan

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance

    Undergo MRI

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given IV

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET scan

  • RetifanlimabBiological

    Also called INCMGA 0012, INCMGA-0012, INCMGA00012, INCMGA0012

    Given IV

Study groups in NCT06320405
Study groupRoleWhat they receive
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.
Receives: Biological: Axatilimab; Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Drug: Paclitaxel; Procedure: Positron Emission Tomography; Biological: Retifanlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 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. Recommended phase 2 dose of the study drug combination (phase Ib)

    Measured: 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])

  3. 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.

    Measured: 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)

  1. Incidence of ≥ grade 3 toxicities possibly or definitely related to study drugs

    Will be categorized and tabulated for reporting. The analyses for reporting may include descriptive statistical analyses of the overall set of phase II adverse events.

    Measured: From the first dose of axatilimab (day -8) to 90 days after the end of treatment visit (an average of 6 months)

  2. Changes in immune cell composition and functionality

    Will be characterized in peripheral blood using flow cytometry (FC) and candidate protein biomarkers will be identified in tumor tissue using multiplexed immunohistochemistry. Changes in immune cell composition and functionality at the biopsy during cycle 2 will be assessed by paired t-test.

    Measured: 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])

  3. Change in immune cell population

    To assess predictive biomarkers of response in peripheral blood, changes in immune cell populations in peripheral blood, including reduced presence of CD14dimCD16+ monocytes and increased presence of CD8+ T effector memory subsets, at the end of the study between responders and non-responders will be assessed using repeated measures of analysis of covariance over time to accommodate a longitudinal nature of peripheral blood draws for flow cytometry.

    Measured: From screening to end of treatment visit (an average of 6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2024
  2. Study start21 May 2024
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion1 Apr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06320405
Sponsor's protocol ID
STUDY00025940
Other IDs
NCI-2024-01397, STUDY00025940
Status last verified
Jul 2026
First submitted
5 Mar 2024
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Axatilimab, Biopsy and Biospecimen Collection in people with Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, run by OHSU Knight Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose limiting toxicities (phase Ib) (time frame: 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])). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06320405.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.

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