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

NCT07159828 | Terminated Phase 1 FDA Drug

• 1 other identifier: AXN2510X2101
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Solid Tumor, Adult

Keywords

PD-L1; VEGF; Immuno-Oncology; Solid Tumor; AXN-2510; IMM2510

Outcome Measures

Primary Outcomes (2)

• Incidence of Dose-Limiting Toxicities (DLTs)

  A DLT is defined as a toxicity occurring during the DLT observation period

  The first cycle of treatment (Cycle 1, Days 1-21)

• Incidence of adverse events (AEs) and serious adverse events (SAEs)

  AEs are defined and graded according to the NCI CTCAE version 5.0

  From the informed consent until Day 30 post-last dose.

Secondary Outcomes (8)

• Identify if AXN-2510 is helping patients.

  Measured every 6 weeks for 48 weeks and every 12 weeks thereafter from first dose until disease progression or completion of the study (approximately 2 years)

• Pharmacokinetic (PK) measure: area under the concentration-time curve over the dosing interval (AUCtau)

  Measured from pre-infusion Cycle 1 to Day 30 post last dose.

• Pharmacokinetic (PK) measure: minimum observed serum concentration (Cmin)

  Measured from pre-infusion Cycle 1 to Day 30 post last dose.

• Pharmacokinetic (PK) measure: maximum observed serum concentration (Cmax)

  Measured from pre-infusion Cycle 1 to Day 30 post last dose.

• Pharmacokinetic (PK) measure: time at which maximum serum concentration occurs (Tmax)

  Measured from pre-infusion Cycle 1 to Day 30 post last dose.

Study Arms (1)

AXN-2510

EXPERIMENTAL

AXN-2510 given as intravenous (IV) infusion every 3 weeks, for a maximum of 24 months of treatment or until discontinuation criteria is met. Two increasing dose levels will be tested.

Biological: AXN-2510

Interventions

AXN-2510 BIOLOGICAL

AXN-2510 is an antibody with PD-L1 blocking and VEGF inhibition activity in one drug. This is called a bispecific antibody, because it has 2 activities. This immuno-oncology treatment is in development for the treatment of solid tumors. AXN-2510 is differentiated from other PD-L1 and VEGF bispecific antibodies by its ability to inhibit multiple VEGF molecules and also increased antibody-dependent cellular cytotoxicity (ADCC) that can directly kill PD-L1-positive tumor cells.

AXN-2510

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Gross hemoptysis within 2 months of enrollment (defined as coughing up ≥ 0.5 teaspoons of fresh blood or small blood clots).
• Concurrent use of therapeutic anticoagulation or anti-platelet agents.
• History of perforation and/or fistula of the gastrointestinal tract, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), acute gastrointestinal bleeding within 6 months before enrollment, or extensive bowel resection within 6 months prior to enrollment.
• History of stroke, transient ischemic attack, or clinically significant thromboembolic event within 6 months prior to enrollment.
• Tumors with radiographic evidence of blood vessel invasion, central necrosis or intratumor cavitation, encasement of organs (e.g. heart, trachea, esophagus, central bronchi) or major blood vessels (e.g. central pulmonary artery, central pulmonary veins, aorta, brachiocephalic artery, common carotid artery, subclavian artery, superior vena cava).
• 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.

Sponsors & Collaborators

• Axion Bio, Inc: lead
• Instil Bio: collaborator

Study Sites (7)

Carolina BioOncology

Huntersville, North Carolina, 28078, United States

Location

Sarah Cannon Research Institute at Mary Crowley

Dallas, Texas, 75251, United States

Location

New Experimental Therapeutics (NEXT) Oncology - Houston

Houston, Texas, 77054, United States

Location

NEXT Houston

Houston, Texas, 77054, United States

Location

New Experimental Therapeutics of San Antonio - NEXT Oncology

San Antonio, Texas, 78229, United States

Location

NEXT San Antonio

San Antonio, Texas, 78229, United States

Location

NEXT Virginia

Fairfax, Virginia, 22031, United States

Location

Study Officials

• Jill I Loftiss, RN

  Instil Bio

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose escalation and expansion trial.

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: September 8, 2025
• Study Start: September 15, 2025
• Primary Completion: April 16, 2026
• Study Completion: April 16, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)