RECRUITING

A Study to Assess AXN-2510 Treatment in Adult Patients With Advanced Solid Tumors

Conditions

Solid Tumor, Adult PD-L1 VEGF Immuno-Oncology Solid Tumor AXN-2510

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to learn more about the side effects and best dose of AXN-2510 in adults with advanced solid tumors. The main questions it aims to answer are: * What are the side effects of AXN-2510? * Which is the best tolerated dose of AXN-2510? * How long does AXN-2510 stay in your body? Participants will receive AXN-2510 every 3 weeks. Participants will visit the clinic for checkups and tests several days during the first and third doses, and once every 3 weeks for other doses.

Official Title

A Phase 1 Open-label Study to Assess AXN-2510 Monotherapy in Adult Patients With Advanced Solid Tumors

Quick Facts

Study Start:2025-09-15

Study Completion:2027-05-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07159828

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Confirmed diagnosis of an advanced or metastatic solid tumor that is relapsed or refractory following previous therapy, and for which there is no available standard therapy. * Availability of PD-L1 Tumor Proportion Score (TPS) or Combined Positive Score (CPS); OR willingness to submit tumor tissue, if available, for central testing. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. * Age ≥ 18 years at the time of signing the informed consent. * Adequate hepatic function. * Adequate renal function. * Adequate bone marrow function. * Adequate blood clotting function	* Active, untreated brain metastases or leptomeningeal disease requiring immediate local therapy, with some exceptions. * Concurrent malignancy that is progressing or requires active treatment, with some exceptions. * Received prior treatment within 5 half-lives or 4 weeks prior to starting AXN-2510, whichever is shorter (6 weeks for nitrosourea or mitomycin-C). Patients with prostate or breast cancer may continue concurrent hormone therapy. * Current use of immune-suppressive medication at the time of study enrollment, with some exceptions. * Uncontrolled hypertension defined as blood pressure of ≥ 160 mmHg systolic and/or ≥ 95 mmHg diastolic. * Active or clinically significant bleeding within 6 months for major bleeding or within 4 weeks for minor bleeding prior to Screening. * History of stroke, transient ischemic attack, or clinically significant thromboembolic event within 6 months prior to enrollment. * Radiographic evidence of tumor invasion into major blood vessels (e.g., pulmonary artery, carotid artery) or tumors with central necrosis or cavitation. * Impaired cardiac function or significant diseases. * History of pulmonary fibrosis or interstitial pneumonia, pneumoconiosis, chemical pneumonia, interstitial lung disease requiring steroids, or other diseases causing severe impairment of lung function. * Unresolved toxicity higher than Grade 1 CTCAE v5 (or most current version) attributed to any prior therapy or procedure at Screening, with exceptions for alopecia or Grade 2 neuropathy. * Any prior Grade 4 immune-mediated adverse event (imAE) or Grade 3 imAE requiring steroid treatment while receiving immunotherapy that has been documented within the 12 months prior to the enrollment period. * Known human immunodeficiency virus (HIV) or acquired immune deficiency syndromes. Note: well-controlled HIV will be allowed. * Positive hepatitis B surface antigen and/or hepatitis B core antibody (participants with negative polymerase chain reaction assay are permitted with appropriate antiviral therapy). * Active hepatitis C infection with positive viral loads. Participants who have been treated for hepatitis C infection can be included if they have documented sustained virologic response of ≥ 12 weeks. * Known history of any grade hypersensitivity reactions (despite appropriate premedication) to any known components of AXN-2510 or required premedication. * Women who are pregnant or lactating. * Has a history or current evidence of any condition, therapy, or laboratory abnormality that in the opinion of the investigator, might confound the results of the trial.

Inclusion Criteria

Exclusion Criteria

* Confirmed diagnosis of an advanced or metastatic solid tumor that is relapsed or refractory following previous therapy, and for which there is no available standard therapy.
* Availability of PD-L1 Tumor Proportion Score (TPS) or Combined Positive Score (CPS); OR willingness to submit tumor tissue, if available, for central testing.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
* Age ≥ 18 years at the time of signing the informed consent.
* Adequate hepatic function.
* Adequate renal function.
* Adequate bone marrow function.
* Adequate blood clotting function

* Active, untreated brain metastases or leptomeningeal disease requiring immediate local therapy, with some exceptions.
* Concurrent malignancy that is progressing or requires active treatment, with some exceptions.
* Received prior treatment within 5 half-lives or 4 weeks prior to starting AXN-2510, whichever is shorter (6 weeks for nitrosourea or mitomycin-C). Patients with prostate or breast cancer may continue concurrent hormone therapy.
* Current use of immune-suppressive medication at the time of study enrollment, with some exceptions.
* Uncontrolled hypertension defined as blood pressure of ≥ 160 mmHg systolic and/or ≥ 95 mmHg diastolic.
* Active or clinically significant bleeding within 6 months for major bleeding or within 4 weeks for minor bleeding prior to Screening.
* History of stroke, transient ischemic attack, or clinically significant thromboembolic event within 6 months prior to enrollment.
* Radiographic evidence of tumor invasion into major blood vessels (e.g., pulmonary artery, carotid artery) or tumors with central necrosis or cavitation.
* Impaired cardiac function or significant diseases.
* History of pulmonary fibrosis or interstitial pneumonia, pneumoconiosis, chemical pneumonia, interstitial lung disease requiring steroids, or other diseases causing severe impairment of lung function.
* Unresolved toxicity higher than Grade 1 CTCAE v5 (or most current version) attributed to any prior therapy or procedure at Screening, with exceptions for alopecia or Grade 2 neuropathy.
* Any prior Grade 4 immune-mediated adverse event (imAE) or Grade 3 imAE requiring steroid treatment while receiving immunotherapy that has been documented within the 12 months prior to the enrollment period.
* Known human immunodeficiency virus (HIV) or acquired immune deficiency syndromes. Note: well-controlled HIV will be allowed.
* Positive hepatitis B surface antigen and/or hepatitis B core antibody (participants with negative polymerase chain reaction assay are permitted with appropriate antiviral therapy).
* Active hepatitis C infection with positive viral loads. Participants who have been treated for hepatitis C infection can be included if they have documented sustained virologic response of ≥ 12 weeks.
* Known history of any grade hypersensitivity reactions (despite appropriate premedication) to any known components of AXN-2510 or required premedication.
* Women who are pregnant or lactating.
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that in the opinion of the investigator, might confound the results of the trial.

Contacts and Locations

Study Contact

Kevin H Laubscher, PhD

CONTACT

972-499-3350

kevin.laubscher@instilbio.com

Jill I Loftiss, RN

CONTACT

972-499-3350

jill.loftiss@instilbio.com

Principal Investigator

Jill I Loftiss, RN

STUDY_DIRECTOR

Instil Bio

Study Locations (Sites)

Carolina BioOncology

Huntersville, North Carolina, 28078

United States

New Experimental Therapeutics (NEXT) Oncology - Houston

Houston, Texas, 77054

United States

NEXT Houston

Houston, Texas, 77054

United States

New Experimental Therapeutics of San Antonio - NEXT Oncology

San Antonio, Texas, 78229

United States

NEXT San Antonio

San Antonio, Texas, 78229

United States

NEXT Virginia

Fairfax, Virginia, 22031

United States

NEXT Virginia

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: Instil Bio

Jill I Loftiss, RN, STUDY_DIRECTOR, Instil Bio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-15

Study Completion Date2027-05-15

Study Record Updates

Study Start Date2025-09-15

Study Completion Date2027-05-15

Terms related to this study

Keywords Provided by Researchers

PD-L1
VEGF
Immuno-Oncology
Solid Tumor
AXN-2510

Additional Relevant MeSH Terms

Solid Tumor, Adult