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PYX-106

Phase 1

Solid Tumor | Small molecule | Oncology |Pyxis Oncology, Inc.|Last Updated: Aug 3, 2025

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment47
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05718557Study of PYX-106 in Solid TumorsPHASE1 ACTIVE NOT_RECRUITING 47May 23, 2023May 1, 2026Aug 3, 202520 United States, Belgium +1
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Study Endpoints
Primary Endpoints
Number of Participants Who Experience a Dose-Limiting Toxicity (DLT)
Day 1 to Day 28
Number of Participants Who Experience an Adverse Event (AE)
Day 1 up to approximately 19 months

Type, incidence, seriousness and causality of AEs based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Any clinically significant changes in clinical laboratory parameters, vital signs, and electrocardiogram (ECG) parameters will be recorded as AEs.

Secondary Endpoints
Maximum Concentration (Cmax) of PYX-106
Day 1 up to approximately 2 years
Time to Maximum Concentration (Tmax) of PYX-106
Day 1 up to approximately 2 years
Area Under the Time Concentration Curve from Time 0 to the Last Quantifiable Concentration (AUC0-t) of PYX-106
Day 1 up to approximately 2 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PYX-106 Dose EscalationEXPERIMENTALParticipants will receive escalating doses of PYX-106 to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of PYX-106, and to determine the recommended dose(s).
Interventions
NameTypeDescription
PYX-106DRUGIntravenous (IV) infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: 1. Participants with histologically or cytologically confirmed solid tumors who have relapsed, been non-responsive, or have developed disease progression through standard therapy. 2. Histologically or cytologically confirmed solid tumors (see details below): For the dose esc...

Countries:United StatesBelgiumSpain
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05718557primaryCompletionDate: changed
LOWMay 24, 2026NCT05718557studyFirstPostDate: changed