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PYX-201

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Pyxis Oncology, Inc.|Last Updated: Jun 30, 2026

Success Probability
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Market & Valuation
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Trial Design
CONTROLLED
Total Trials1
Total Enrollment220
FDA Designations
ORPHAN_DRUGFAST_TRACK
Clinical trial landscape

PYX-201 · 2 trials · 3 indications

Phase 1 2
NCT06795412Phase 1/2 Study of PYX-201 in Combination With Pembrolizumab in Advanced Solid TumorsAdvanced Solid Tumors
RECRUITING220 Analytics
NCT05720117A Study of PYX-201 in Advanced Solid TumorsSolid Tumor
RECRUITING330 Analytics
PHASE1RECRUITING
Phase 1/2 Study of PYX-201 in Combination With Pembrolizumab in Advanced Solid Tumors
Advanced Solid TumorsUnlock trial analytics
PHASE1RECRUITING
A Study of PYX-201 in Advanced Solid Tumors
Solid TumorUnlock trial analytics
Study Endpoints
Primary Endpoints
Number of Participants who Experience a Dose-Limiting Toxicity (DLT)
Day 1 to Day 21
Number of Participants who Experience an Adverse Event (AE)
Up to approximately 2 years
Number of Participants who Experience Clinically Significant Changes in Clinical Laboratory Parameters
Up to approximately 2 years
Number of Participants who Experience Clinically Significant Changes in Vital Signs
Up to approximately 2 years
Number of Participants who Experience Clinically Significant Changes in electrocardiogram (ECG) Parameters
Up to approximately 2 years
Number of Participants who Experience a Dose-limiting Toxicity (DLT) in Dose Escalation
Day 1 to Day 21

DLT is defined as (1) an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs after the treatment with PYX-201 and (2) meets any of the predefined criteria outlined in the protocol.

Safety and Tolerability as assessed by adverse event monitoring for participants in Dose Escalation
Up to approximately 3 years

Adverse Events as characterized by type, incidence, seriousness, relationship to study treatment, timing, and severity (as graded by NCI-CTCAE Version 5.0). Any clinically significant changes in clinical laboratory parameters, vital signs, and electrocardiogram (ECG) parameters will be recorded as AEs.

Objective Response Rate (ORR) observed in participants in Dose Expansion
Up to approximately 2 years
Secondary Endpoints
Objective Response Rate (ORR)
Day 1 up to approximately 2 years
Duration of Response (DOR)
Day 1 up to approximately 2 years
Disease Control Rate (DCR)
Day 1 up to approximately 2 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1: Dose EscalationEXPERIMENTALParticipants will receive escalating doses of PYX-201 to evaluate the safety, tolerability, and preliminary efficacy of PYX-201 in combination with pembrolizumab.
Part 2: Dose ExpansionEXPERIMENTALPart 2 dose-expansion cohorts will be opened based on emerging data to further inform the safety, tolerability, and preliminary efficacy determinations as defined.
Dose EscalationEXPERIMENTAL -
Dose Expansion Cohort A (HNSCC)EXPERIMENTAL -
Dose Expansion Cohort B (TNBC)EXPERIMENTAL -
Dose Expansion Cohort C (HR+ HER2- BC)EXPERIMENTAL -
Dose Expansion Cohort D (Other Solid Tumor Types)EXPERIMENTAL -
Interventions
NameTypeDescription
PYX-201DRUGIntravenous (IV) infusion.
pembrolizumabDRUGIV infusion.
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria 1. Histologically or cytologically confirmed advanced solid tumors, including first-line (1L) head and neck squamous cell carcinoma (HNSCC), advanced or metastatic triple negative breast cancer (TNBC), hormone receptor positive (HR+) and human epidermal growth factor receptor 2 n...

Countries:United StatesFranceSpainBelgiumUnited Kingdom
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")
Recent Changes (Last 90 Days)
MEDIUMJun 30, 2026NCT05720117primaryCompletionDate: changed
MEDIUMJun 30, 2026NCT05720117primaryCompletionDate: changed
MEDIUMJun 30, 2026NCT05720117primaryCompletionDate: changed
LOWMay 26, 2026NCT06795412primaryCompletionDate: changed
LOWMay 26, 2026NCT05720117primaryCompletionDate: changed
LOWMay 24, 2026NCT06795412studyFirstPostDate: changed
LOWMay 24, 2026NCT05720117studyFirstPostDate: changed