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New drug duo targets Hard-to-Treat cancers

NCT ID NCT06795412

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Updated 2 times

Summary

This study tests a new drug called PYX-201 combined with pembrolizumab in people with advanced solid tumors that have not responded to other treatments. The goal is to find safe doses and see if the combination can shrink tumors. About 220 adults with certain cancers like head and neck, breast, or stomach cancer can join.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 220 people

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

Started

Apr 2025

Expected to finish

Dec 2027

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 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 negative breast cancer (HER2- BC), gastric cancer (GC), cervical cancer, and second-line and higher (2L+) HNSCC. 2. Male or non-pregnant, non-lactating female participants age ≥18 years. 3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1. 4. Participant must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. 5. Life expectancy of \>3 months, in the opinion of the Investigator. 6. Adequate hematologic function. 7. Adequate hepatic function. 8. Adequate renal function. 9. Adequate coagulation profile. 10. Clinical sites must conduct fresh tumor biopsy or provide participant's archived tumor tissue sample. Exclusion Criteria 1. Known additional malignancy that is progressing or has required active treatment within the past 2 years. 2. Have any active central nervous system (CNS) metastases and/or carcinomatous meningitis. 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 National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 Grade ≤1 from acute non-hematologic toxicity due to previous therapy, prior to Screening. 7. Participants with Grade \>1 neuropathy of any grade per CTCAE v5.0 and/or receiving treatment for neuropathy at Screening. 8. History of uncontrolled diabetes mellitus. 9. Participants with immunodeficiency or active autoimmune disease that is contraindicated for pembrolizumab. 10. Participants with a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD. 11. Prior solid organ or bone marrow progenitor cell transplantation. 12. Prior high-dose chemotherapy requiring stem cell rescue. 13. Previously received treatment with a programmed death-1 (PD-1)/L1 inhibitor any prior treatment with an agent directed to another stimulatory or co inhibitory T-cell receptor. 14. Severe hypersensitivity (Grade ≥3) to pembrolizumab and/or any of its excipients and/or PYX-201 and/or any of its excipients.

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Conditions

The condition(s) this trial relates to.

cervical cancer gastric cancer head and neck squamous cell carcinoma hormone receptor-positive breast cancer neoplasm triple-negative breast carcinoma

As listed by the trial registrant

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

Advanced solid tumors Advanced solid tumours

How to take part

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

  1. The places running it

    22 sites in 3 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

  • Centre Léon Bérard

    RECRUITING

    Lyon, 69373, France

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Hopital Saint - Andre - CHU de Bordeaux

    RECRUITING

    Bordeaux, 33075, France

  • Hospital Clínico Universitario de Valencia

    RECRUITING

    Valencia, 46010, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Ramón y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hôpital de la Timone

    RECRUITING

    Marseille, 13385, France

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, 94800, France

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • NEXT Oncology Houston

    RECRUITING

    Houston, Texas, 77054, United States

  • NEXT Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • START Madrid - Hospital Universitario Fundación Jiménez Díaz

    RECRUITING

    Madrid, 28040, Spain

  • Sarcoma Oncology Center

    RECRUITING

    Santa Monica, California, 90403, United States

  • Stephenson Cancer Center - University of Oklahoma

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of California San Diego

    RECRUITING

    San Diego, California, 92093, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Texas - M.D. Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.