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AXN-2510

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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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 Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07159828A Study to Assess AXN-2510 Treatment in Adult Patients With Advanced Solid TumorsPHASE1 TERMINATED 3 — — Sep 15, 2025Apr 16, 2026May 6, 20267 United States
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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 — 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