Study of PYX-106 in Solid Tumors

Last updated: April 30, 2025
Sponsor: Pyxis Oncology, Inc
Overall Status: Active - Not Recruiting

Phase

1

Condition

Neoplasms

Neuroblastoma

Treatment

PYX-106

Clinical Study ID

NCT05718557
PYX-106-101
2022-002306-24
2023-509686-21-00
  • Ages > 18
  • All Genders

Study Summary

The primary objective of this study is to determine the recommended dose(s) of PYX-106 in participants with relapsed/refractory solid tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants with histologically or cytologically confirmed solid tumors who haverelapsed, been non-responsive, or have developed disease progression throughstandard therapy.

  2. Histologically or cytologically confirmed solid tumors (see details below): For the dose escalation, the following solid tumors are allowed in participants whohave relapsed, been non-responsive, or have developed disease progression throughstandard therapy and in participants for whom standard of care therapy that prolongssurvival is unavailable or unsuitable (according to the Investigator and afterinforming the Medical Monitor): non small cell lung cancer (without drivermutations/translocations), breast cancer, endometrial cancer, thyroid cancer, kidneycancer, cholangiocarcinoma, bladder cancer, colorectal cancer, and head and necksquamous cell carcinoma.

  3. Clinical sites must provide archived tissue or conduct fresh tumor biopsy (formalin-fixed paraffin-embedded [FFPE]; enough to create a minimum of 14 slides).Fresh biopsy pre-treatment is preferred, archival tissue (preferably obtained within 1 year prior to the first infusion of PYX-106) is acceptable if fresh biopsy is notmedically feasible, per Investigator, at Screening. Both fresh and archival tissuesamples must be collected by core needle biopsy or surgical resection. Fine needleaspirates are not permitted.

  4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.

  5. Participant must have at least 1 measurable lesion per Response Evaluation Criteriain Solid Tumor (RECIST) Version 1.1 criteria (by local Investigator). Participantmust have radiographic evidence of disease progression per Investigator followingthe most recent line of treatment.

  6. Life expectancy of >3 months, in the opinion of the Investigator.

Exclusion

Exclusion Criteria:

  1. History of another malignancy except for the following: adequately treated localbasal cell or squamous cell carcinoma of the skin; in situ cervical carcinoma,adequately treated; other adequately treated Stage 1 or 2 cancers currently incomplete remission; any other cancer that has been in complete remission for >2years or cancer of low risk of recurrence; or any treated or monitored indolentcancer that is unlikely to cause mortality in 5 years.

  2. Known symptomatic brain metastases requiring >10 mg/day of prednisolone (or itsequivalent) at the time of signing informed consent.

  3. Continuance of toxicities due to prior anti-cancer agents that do not recover toGrade 1 prior to start of PYX-106 treatment, except for alopecia or endocrinedeficiencies treated with stable hormone replacement therapy.

  4. Presence of Grade ≥2 peripheral neuropathy.

  5. Major surgery within 4 weeks prior to the start of PYX-106 treatment, as defined bythe Investigator.

  6. Received palliative radiation therapy within 14 days prior to the start of PYX-106treatment.

  7. Received a live vaccine within 28 days prior to the first dose of study treatmentand while participating in the study.

Study Design

Total Participants: 47
Treatment Group(s): 1
Primary Treatment: PYX-106
Phase: 1
Study Start date:
May 23, 2023
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, Flemish Brabant 3000
    Belgium

    Site Not Available

  • Grand Hôpital de Charleroi - Notre Dame

    Charleroi, Hainaut 6000
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Gent

    Gent, Oost-Vlaanderen 9000
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200
    Belgium

    Site Not Available

  • Hospital Universitari Dexeus

    Barcelona, 08028
    Spain

    Site Not Available

  • HM Centro Integral Oncológico Clara Campal

    Madrid, 28050
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • START Madrid - Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • HonorHealth Research Institute

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • University of California San Diego

    La Jolla, California 92093
    United States

    Site Not Available

  • University of Southern California

    Los Angeles, California 90033
    United States

    Site Not Available

  • SCRI - HealthOne Denver

    Denver, Colorado 80218
    United States

    Site Not Available

  • SCRI- HealthOne Denver

    Denver, Colorado 80218
    United States

    Site Not Available

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • University of Chicago Medicine

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Gabrail Cancer and Research Center

    Canton, Ohio 44718
    United States

    Site Not Available

  • Lifespan - Rhode Island Hospital

    Providence, Rhode Island 02906
    United States

    Site Not Available

  • NEXT Oncology

    Irving, Texas 75039
    United States

    Site Not Available

  • NEXT Virginia

    Fairfax, Virginia 22031
    United States

    Site Not Available

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