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PYX-106

Phase 1

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

Target and mechanism

Molecular targetSiglec-15
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment47

FDA Designations

No designations recorded

Clinical trial landscape

PYX-106 · 1 trial · 1 indication

Phase 1 1
NCT05718557Study of PYX-106 in Solid TumorsSolid Tumor
ACTIVE NOT_RECRUITING47 Analytics
PHASE1ACTIVE NOT_RECRUITING
Study of PYX-106 in Solid Tumors
Solid TumorUnlock trial analytics

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 to 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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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumor")

Frequently asked questions about PYX-106

What is PYX-106 used for in solid tumors?

PYX-106 is an investigational small molecule being developed for the treatment of solid tumors. It is currently in Phase 1 clinical development, with an active clinical trial studying its effects in patients with solid tumors. The drug is not yet approved and remains under investigation.

What does PYX-106 target?

PYX-106 targets Siglec-15, a protein involved in the regulation of immune responses. By targeting Siglec-15, PYX-106 may modulate the tumor microenvironment to potentially enhance anti-tumor immunity. This mechanism is being evaluated in early-phase clinical trials for solid tumors.

Who is developing PYX-106?

PYX-106 is being developed by Pyxis Oncology, Inc., a biopharmaceutical company. The company is conducting a Phase 1 clinical trial to evaluate the safety and efficacy of PYX-106 in patients with solid tumors. Pyxis Oncology is publicly traded under the ticker symbol PYXS.

What phase is PYX-106 in?

PYX-106 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is actively enrolling or has completed enrollment, with a total of 47 participants planned, and is being conducted in the United States, Belgium, and Spain.

What clinical trials is PYX-106 in?

PYX-106 is being studied in a Phase 1 clinical trial with the identifier NCT05718557, titled 'Study of PYX-106 in Solid Tumors.' This trial is active but not recruiting, with an enrollment of 47 participants. It is an open-label, uncontrolled study involving adult patients with solid tumors.

Is PYX-106 the same as any other drug?

PYX-106 is the primary name for this investigational drug. No alternative names have been reported for PYX-106. It is a distinct small molecule targeting Siglec-15, currently in Phase 1 development for solid tumors by Pyxis Oncology.