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New hope for advanced cancers? early trial of PYX-201 begins

NCT ID NCT05720117

Disease control Sponsor: Pyxis Oncology, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times

Summary

This early-phase study tests a new drug called PYX-201 in people with advanced solid tumors that have come back or spread. The main goals are to find a safe dose and see if the drug can shrink tumors. About 330 adults with certain breast, head and neck, or other cancers are being enrolled.

Why investors are watching

Pyxis Oncology is a very small company, and this phase 1 trial of its drug PYX-201 is its main event. The trial tests the drug's safety and whether it shrinks tumors in people with advanced solid tumors. For a micro-cap company, this early data will largely determine how investors view the drug's future.

If it works: If PYX-201 shows a clear safety profile and signs of tumor shrinkage, the company could attract partnership interest or funding to move the drug into later trials. A positive readout would validate the drug's potential and give the company a path forward.

If it fails: Phase 1 trials often fail to show enough benefit or reveal safety problems, and this one could too. A weak result or a delay would likely hurt the company's prospects, since it has few other assets to fall back on.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 330 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2023

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma hormone receptor-positive breast cancer neoplasm Neoplasm Metastasis triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor Solid tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    28 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cliniques Universitaires Saint-Luc

    RECRUITING

    Brussels, Brussels Capital, 1200, Belgium

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • HonorHealth Research Institute

    RECRUITING

    Scottsdale, Arizona, 85258, United States

  • Hospital Clínico Universitario de Valencia

    RECRUITING

    Valencia, València, 46010, Spain

  • Hospital Universitari Vall d'Hebrón

    RECRUITING

    Barcelona, Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, Madrid, 28041, Spain

  • Hospital Universitario HM Sanchinarro

    RECRUITING

    Madrid, Madrid, 28050, Spain

  • Institut Jules Bordet

    RECRUITING

    Brussels, Brussels Capital, 1070, Belgium

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • NEXT Dallas

    RECRUITING

    Dallas, Texas, 75231, United States

  • NEXT San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • NEXT Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Rhode Island Hospital

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • Ronald Reagan UCLA Medical Center

    RECRUITING

    Los Angeles, California, 90095, United States

  • SCRI - Florida Cancer Specialists

    RECRUITING

    Sarasota, Florida, 34232, United States

  • SCRI - HealthOne Denver

    RECRUITING

    Denver, Colorado, 80218, United States

  • START Madrid - Hospital Universitario Fundación Jiménez Díaz

    RECRUITING

    Madrid, Madrid, 28040, Spain

  • Sarah Cannon Research Institute London

    ACTIVE_NOT_RECRUITING

    London, England, W1G 6AD, United Kingdom

  • The Royal Marsden Hospital

    RECRUITING

    London, England, SW3 6JJ, United Kingdom

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Universitair Ziekenhuis Antwerpen

    RECRUITING

    Edegem, Edegem, 2650, Belgium

  • Universitair Ziekenhuis Gent

    RECRUITING

    Ghent, Gent, 9000, Belgium

  • University College Hospital

    RECRUITING

    London, England, NW1 2PG, United Kingdom

  • University of Chicago Medicine

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Cincinnati Medical Center

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • University of Pennsylvania, Abramson Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19106, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110-1010, United States

  • Winship Cancer Institute, Emory University

    RECRUITING

    Atlanta, Georgia, 30308, United States

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