A Study of PYX-201 in Advanced Solid Tumors

June 26, 2026 updated by: Pyxis Oncology, Inc

A First-in-Human, Open-label, Multicenter, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PYX-201 in Participants With Advanced Solid Tumors

The primary objectives of this study are to determine the recommended dose(s) of PYX-201 for participants with recurrent/metastatic (R/M) solid tumors, and to determine the objective response rate (ORR) in participants treated with PYX-201 as a single agent.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
330

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
    • Brussels Capital
      • Brussels, Brussels Capital, Belgium, 1200
        • Recruiting
        • Cliniques universitaires Saint-Luc
      • Brussels, Brussels Capital, Belgium, 1070
        • Recruiting
        • Institut Jules Bordet
    • Edegem
      • Edegem, Edegem, Belgium, 2650
        • Recruiting
        • Universitair Ziekenhuis Antwerpen
    • Gent
      • Ghent, Gent, Belgium, 9000
        • Recruiting
        • Universitair Ziekenhuis Gent
  • Spain
    • Barcelona
      • Barcelona, Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
    • Madrid
      • Madrid, Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
      • Madrid, Madrid, Spain, 28040
        • Recruiting
        • START Madrid - Hospital Universitario Fundación Jiménez Díaz
      • Madrid, Madrid, Spain, 28050
        • Recruiting
        • Hospital Universitario HM Sanchinarro
    • València
      • Valencia, València, Spain, 46010
        • Recruiting
        • Hospital Clínico Universitario de Valencia
  • United Kingdom
    • England
      • London, England, United Kingdom, NW1 2PG
        • Recruiting
        • University College Hospital
      • London, England, United Kingdom, W1G 6AD
        • Active, not recruiting
        • Sarah Cannon Research Institute London
      • London, England, United Kingdom, SW3 6JJ
        • Recruiting
        • The Royal Marsden Hospital
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Recruiting
        • HonorHealth Research Institute
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • Ronald Reagan UCLA Medical Center
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • SCRI - HealthOne Denver
    • Florida
      • Sarasota, Florida, United States, 34232
        • Recruiting
        • SCRI - Florida Cancer Specialists
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Winship Cancer Institute, Emory University
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
    • Missouri
      • St Louis, Missouri, United States, 63110-1010
        • Recruiting
        • Washington University School of Medicine
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19106
        • Recruiting
        • University of Pennsylvania, Abramson Cancer Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Rhode Island Hospital
    • Texas
      • Dallas, Texas, United States, 75231
        • Recruiting
        • NEXT Dallas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas MD Anderson Cancer Center
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • NEXT San Antonio
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • NEXT Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion

  1. Histologically or cytologically confirmed solid tumors including locally advanced/metastatic HR+ and HER2- breast cancer (post CDK4/6 inhibitor +/- ET, ≤ 2 lines systemic therapy), TNBC (1-3 prior lines including post ADC topo-1 payload), HNSCC (1-2 prior lines including post PD-L1/PD1 and platinum based therapy), and other solid tumor types (≤ 2 lines systemic therapy).
  2. Male or non-pregnant, non-lactating female participants age ≥18 years.
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1.
  4. Participant must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  5. Life expectancy of >3 months, in the opinion of the Investigator.
  6. Corrected QTcF <470 msec.
  7. Adequate hematologic function.
  8. Adequate hepatic function.
  9. Adequate renal function.
  10. Adequate coagulation profile.
  11. Clinical sites must conduct fresh tumor biopsy or provide participant's archived tumor tissue sample.

Exclusion

  1. History of another malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin; in situ cervical carcinoma; adequately treated, noninvasive bladder cancer.
  2. Known symptomatic brain metastases.
  3. Significant cardiovascular disease within 6 months prior to start of study drug.
  4. Evidence of an active systemic bacterial, fungal, or viral infection requiring treatment at the start of study drug.
  5. Known active hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
  6. Failure to recover to baseline severity or Grade ≤1 NCI-CTCAE v5.0 from acute non-hematologic toxicity.
  7. Participants with NCI-CTCAE v5.0 Grade >1 neuropathy of any etiology.
  8. Prior solid organ or bone marrow progenitor cell transplantation.
  9. Prior high-dose chemotherapy requiring stem cell rescue.
  10. Received systemic anticancer therapy within 28 days or within 5 half-lives (whichever is shorter) prior to the start of study drug.
  11. Palliative radiation therapy within 14 days prior to the start of study drug.
  12. Previously received extra domain B splice variant of fibronectin (EDB+FN) targeting treatments at any time prior to the start of PYX-201 treatment.
  13. History of uncontrolled diabetes mellitus.
  14. History of Stevens-Johnson syndrome or toxic epidermal necrolysis.
  15. Participants with corneal epithelial disease, with the exception of mild punctate keratopathy
  16. Participants with the best-corrected visual acuity in the worst-seeing eye worse than 20/100 (Snellen equivalent).
  17. Participants with a history of (noninfectious) pneumonitis/ interstitial lung disease that required steroids, has current pneumonitis/ interstitial lung disease, or evidence of active pneumonitis on screening chest CT scan or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dose Escalation
Drug: PYX-201
Antibody-Drug Conjugate
Experimental: Dose Expansion Cohort A (HNSCC)
Drug: PYX-201
Antibody-Drug Conjugate
Experimental: Dose Expansion Cohort B (TNBC)
Drug: PYX-201
Antibody-Drug Conjugate
Experimental: Dose Expansion Cohort C (HR+ HER2- BC)
Drug: PYX-201
Antibody-Drug Conjugate
Experimental: Dose Expansion Cohort D (Other Solid Tumor Types)
Drug: PYX-201
Antibody-Drug Conjugate

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants who Experience a Dose-limiting Toxicity (DLT) in Dose Escalation
Time Frame: 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.
Day 1 to Day 21
Safety and Tolerability as assessed by adverse event monitoring for participants in Dose Escalation
Time Frame: 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.
Up to approximately 3 years
Objective Response Rate (ORR) observed in participants in Dose Expansion
Time Frame: Up to approximately 2 years
Up to approximately 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum Observed Concentration (Cmax) of PYX-201 in Dose Escalation and Dose Expansion
Time Frame: Day 1 up to approximately 2 years
Pharmacokinetic (PK) assessments for PYX-201
Day 1 up to approximately 2 years
Time to Maximum Concentration (Tmax) of PYX-201 in Dose Escalation and Dose Expansion
Time Frame: Day 1 up to approximately 2 years
Pharmacokinetic (PK) assessments for PYX-201
Day 1 up to approximately 2 years
Clearance (CL) of PYX-201 in Dose Escalation
Time Frame: Day 1 up to approximately 2 years
Pharmacokinetic (PK) assessments for PYX-201
Day 1 up to approximately 2 years
Area Under the Concentration-time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-t) of PYX-201 in Dose Escalation
Time Frame: Day 1 up to approximately 2 years
Pharmacokinetic (PK) assessments for PYX-201
Day 1 up to approximately 2 years
Area Under the Concentration-time Curve Over the Dosing Interval (AUCtau) of PYX-201 in Dose Escalation
Time Frame: Day 1 up to approximately 2 years
Pharmacokinetic (PK) assessments for PYX-201
Day 1 up to approximately 2 years
Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of PYX-201 in Dose Escalation
Time Frame: Day 1 up to approximately 2 years
Pharmacokinetic (PK) assessments for PYX-201
Day 1 up to approximately 2 years
Half-life (t½) of PYX-201 in Dose Escalation
Time Frame: Day 1 up to approximately 2 years
Pharmacokinetic (PK) assessments for PYX-201
Day 1 up to approximately 2 years
Objective Response Rate (ORR) observed in participants in Dose Escalation
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Duration of Response (DOR) observed in participants in Dose Escalation and Dose Expansion
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Progression-free Survival (PFS) observed in participants in Dose Escalation
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Disease Control Rate (DCR) observed in participants in Dose Escalation and Dose Expansion
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Time to Response (TTR) observed in participants in Dose Escalation and Dose Expansion
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Overall Survival (OS) observed in participants in Dose Escalation
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Incidence of Anti-drug Antibodies (ADA) in participants treated with PYX-201 in Dose Escalation and Dose Expansion
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Clinical Benefit Rate (CBR) observed in participants in Dose Expansion
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Median Progression-free Survival (mPFS) observed in participants in Dose Expansion
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Median Overall Survival (mOS) observed in participants in Dose Expansion
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Cmax of PYX-201 in Dose Expansion
Time Frame: Up to approximately 2 years
Pharmacokinetic (PK) assessments for PYX-201
Up to approximately 2 years
Tmax of PYX-201 in Dose Expansion
Time Frame: Up to approximately 2 years
Pharmacokinetic (PK) assessments for PYX-201
Up to approximately 2 years
Trough Concentration of PYX-201 in Dose Expansion
Time Frame: Up to approximately 2 years
Pharmacokinetic (PK) assessments for PYX-201
Up to approximately 2 years
Safety and Tolerability as assessed by adverse event monitoring for participants in Dose Expansion
Time Frame: Up to approximately 2 years
Adverse Events 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 ECG parameters will be recorded as AEs.
Up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pyxis Oncology, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 14, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 25, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PYX-201-101
  • 2022-002284-30 (EudraCT Number)
  • 2023-509687-14-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings