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AXN-2510

Phase 1

Solid Tumor, Adult | Monoclonal antibody | Oncology |Instil Bio, Inc.|Last Updated: May 6, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded
Trial Stopped -NCT07159828: The study was terminated early due to discontinuation of development of the investigational program.

Clinical trial landscape

AXN-2510 · 1 trial · 1 indication

Phase 1 1
NCT07159828A Study to Assess AXN-2510 Treatment in Adult Patients With Advanced Solid TumorsSolid Tumor, Adult
TERMINATED3 Analytics
PHASE1TERMINATED
A Study to Assess AXN-2510 Treatment in Adult Patients With Advanced Solid Tumors
Solid Tumor, AdultUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Dose-Limiting Toxicities (DLTs)
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)
From the informed consent until Day 30 post-last dose.

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

Secondary Endpoints

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.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AXN-2510EXPERIMENTALAXN-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.

Interventions

NameTypeDescription
AXN-2510BIOLOGICALAXN-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.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion 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 t...

Countries:United States
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Recent Changes (Last 90 Days)

MEDIUMJun 6, 2026NCT07159828TRIAL_REMOVED: changed
MEDIUMJun 6, 2026NCT07159828TRIAL_REMOVED: changed
MEDIUMJun 6, 2026NCT07159828TRIAL_REMOVED: changed
MEDIUMJun 6, 2026NCT07159828TRIAL_REMOVED: changed
MEDIUMJun 6, 2026NCT07159828TRIAL_REMOVED: changed
MEDIUMJun 6, 2026NCT07159828TRIAL_REMOVED: changed
CRITICALMay 26, 2026NCT07159828Status: ACTIVE_NOT_RECRUITING → TERMINATED
LOWMay 24, 2026NCT07159828studyFirstPostDate: changed

Frequently asked questions about AXN-2510

What is AXN-2510 used for?

AXN-2510 is an investigational monoclonal antibody being developed for the treatment of solid tumors in adults. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in patients with advanced solid tumors.

Who makes AXN-2510?

AXN-2510 is being developed by Instil Bio, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol TIL. The company is conducting clinical trials to evaluate this investigational therapy in adult patients with advanced solid tumors.

What phase is AXN-2510 in?

AXN-2510 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 study is designed to assess the treatment in adult patients with advanced solid tumors.

What clinical trials is AXN-2510 in?

AXN-2510 is being studied in a Phase 1 clinical trial registered as NCT07159828, titled 'A Study to Assess AXN-2510 Treatment in Adult Patients With Advanced Solid Tumors.' The trial is being conducted in the United States and enrolls adults aged 18 years and older with advanced solid tumors.

Is AXN-2510 the same as any other drug?

AXN-2510 is a distinct investigational monoclonal antibody developed by Instil Bio, Inc. No alternative names for this drug have been reported in the available clinical trial information. It is being studied specifically for its potential use in treating solid tumors in adults.