Solid Tumor, AdultPhase 1NCT07159828
A Study to Assess AXN-2510 Treatment in Adult Patients With Advanced Solid Tumors
A Phase 1 study testing AXN-2510 in people with Solid Tumor, Adult, run by Axion Bio, Inc at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- AXN-2510
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 7 sitesUnited States
- Study dates
- 15 Sep 2025to 16 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
- 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).
Show all 20Show fewer
- 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.
- Positive hepatitis B surface antigen and/or hepatitis B core antibody (participants with negative polymerase chain reaction assay are permitted with appropriate antiviral therapy). If a hepatitis test was conducted and had a negative result within 30 days of enrollment, an additional test is not required at screening.
- 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. If a hepatitis test was conducted and had a negative result within 30 days of enrollment, an additional test is not required at screening.
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Sarah Cannon Research Institute at Mary Crowley
Dallas, Texas, 75251
NEXT Virginia
Fairfax, Virginia, 22031
New Experimental Therapeutics (NEXT) Oncology - Houston
Houston, Texas, 77054
NEXT Houston
Houston, Texas, 77054
Carolina BioOncology
Huntersville, North Carolina, 28078
New Experimental Therapeutics of San Antonio - NEXT Oncology
San Antonio, Texas, 78229
NEXT San Antonio
San Antonio, Texas, 78229
About this study
Official title: A Phase 1 Open-label Study to Assess AXN-2510 Monotherapy in Adult Patients With Advanced Solid Tumors
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.
Read the detailed description
This is a phase 1 study where all adult participants will receive AXN-2510. There will be 2 increasing doses of AXN-2510 given to participants, the dose given depends on when a participant enters the study. Next will be enrollment of 20 participants at the different doses to obtain more information about side effects, tolerability, and if the drug is helping.
- Conditions
- Solid Tumor, Adult
- Being tested
- AXN-2510
- Keywords
- PD-L1, VEGF, Immuno-Oncology, Solid Tumor, AXN-2510, IMM2510
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AXN-2510Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: AXN-2510 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities (DLTs)
A DLT is defined as a toxicity occurring during the DLT observation period
Measured: 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
Measured: From the informed consent until Day 30 post-last dose.
Secondary outcomes (8)
Identify if AXN-2510 is helping patients.
Use Investigator tumor measurements to identify objective response rate, duration of response, disease control rate, time to response, and progression free survival.
Measured: 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)
Measure the AXN-2510 concentration in blood as a function of time
Measured: Measured from pre-infusion Cycle 1 to Day 30 post last dose.
Pharmacokinetic (PK) measure: minimum observed serum concentration (Cmin)
Measure the minimum serum concentration of AXN-2510
Measured: Measured from pre-infusion Cycle 1 to Day 30 post last dose.
Pharmacokinetic (PK) measure: maximum observed serum concentration (Cmax)
Measure the maximum serum concentration of AXN-2510
Measured: Measured from pre-infusion Cycle 1 to Day 30 post last dose.
Pharmacokinetic (PK) measure: time at which maximum serum concentration occurs (Tmax)
Measure of time to reach maximum plasma concentration after administration of AXN-2510
Measured: Measured from pre-infusion Cycle 1 to Day 30 post last dose.
Changes in Pharmacodynamic (PD) biomarker sVEGF-A
Activity of free soluble vascular endothelial growth factor A (sVEGF-A) will be assessed
Measured: Measured from pre-infusion Cycle 1 to Day 30 post last dose.
Changes in Pharmacodynamic (PD) biomarker T-cells
Changes in T-cell subtypes will be assessed
Measured: Measured from pre-infusion Cycle 1 to Day 30 post last dose.
To evaluate the immunogenicity of AXN-2510.
Measure the amount of participant antibodies created against AXN-2510.
Measured: Measured from pre-infusion Cycle 1 to Day 30 post last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start15 Sep 2025
- Primary completion16 Apr 2026
- Study completion16 Apr 2026
Why it stopped: The study was terminated early due to discontinuation of development of the investigational program.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Dose escalation and expansion trial.
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Axion Bio, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Instil Bio
- Responsible party
- Sponsor
- Investigators
- Jill I Loftiss, RN, Study director, Instil Bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159828
- Sponsor's protocol ID
- AXN2510X2101
- Status last verified
- Apr 2026
- First submitted
- 22 Aug 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Testing of samples may occur late in the study, and may not be available during patient treatment.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-label Study to Assess AXN-2510 Monotherapy in Adult Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07159828
- Acronym / sponsor ID
- AXN2510X2101
- Conditions
- Solid Tumor, Adult
- Keywords
- PD-L1, VEGF, Immuno-Oncology, Solid Tumor, AXN-2510, IMM2510
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to discontinuation of development of the investigational program.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Axion Bio, IncIndustry (pharma, biotech, devices)
- Collaborators
- Instil Bio
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 16 Apr 2026 (actual)
- Study completion
- 16 Apr 2026 (actual)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase 1 study where all adult participants will receive AXN-2510. There will be 2 increasing doses of AXN-2510 given to participants, the dose given depends on when a participant enters the study. Next will be enrollment of 20 participants at the different doses to obtain more information about side effects, tolerability, and if the drug is helping.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose escalation and expansion trial.
| Arm | Type | Receives |
|---|---|---|
| AXN-2510 | Experimental | Biological: AXN-2510AXN-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AXN-2510AXN-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. | Biological | AXN-2510 |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: The first cycle of treatment (Cycle 1, Days 1-21)
A DLT is defined as a toxicity occurring during the DLT observation period
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: From the informed consent until Day 30 post-last dose.
AEs are defined and graded according to the NCI CTCAE version 5.0
8 secondary outcomes
Identify if AXN-2510 is helping patients.
Time frame: 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)
Time frame: Measured from pre-infusion Cycle 1 to Day 30 post last dose.
Pharmacokinetic (PK) measure: minimum observed serum concentration (Cmin)
Time frame: Measured from pre-infusion Cycle 1 to Day 30 post last dose.
Pharmacokinetic (PK) measure: maximum observed serum concentration (Cmax)
Time frame: Measured from pre-infusion Cycle 1 to Day 30 post last dose.
Pharmacokinetic (PK) measure: time at which maximum serum concentration occurs (Tmax)
Time frame: Measured from pre-infusion Cycle 1 to Day 30 post last dose.
Changes in Pharmacodynamic (PD) biomarker sVEGF-A
Time frame: Measured from pre-infusion Cycle 1 to Day 30 post last dose.
Changes in Pharmacodynamic (PD) biomarker T-cells
Time frame: Measured from pre-infusion Cycle 1 to Day 30 post last dose.
To evaluate the immunogenicity of AXN-2510.
Time frame: Measured from pre-infusion Cycle 1 to Day 30 post last dose.
Results and safety
The study was stopped early (reason given: The study was terminated early due to discontinuation of development of the investigational program.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No. Testing of samples may occur late in the study, and may not be available during patient treatment.
Related trials for Solid Tumor, Adult
Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
Active, not recruitingPhase 1
Advanced or Recurrent Solid Tumors Treated With SHetA2
Solid Tumor, Adult
RecruitingObservational study
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Very Rare Tumors, Very Rare Cancers
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill I Loftiss, RN study director
Instil Bio
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AXN-2510 in people with Solid Tumor, Adult, run by Axion Bio, Inc at 7 sites 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 8 inclusion and 20 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: stopped early, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated early due to discontinuation of development of the investigational program.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicities (DLTs) (time frame: The first cycle of treatment (Cycle 1, Days 1-21)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2026.