Who is eligible for clinical trial NCT05718557?

Participants must meet protocol criteria for Solid Tumor. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05718557 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-08-01

Study of PYX-106 in Solid Tumors (NCT05718557)

🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Pyxis Oncology, Inc

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (8 items).

Location: HonorHealth Research Institute — Scottsdale, Arizona

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Participants with histologically or cytologically confirmed solid tumors who have relapsed, been non-responsive, or have developed disease progression through standard therapy.
Histologically or cytologically confirmed solid tumors (see details below): For the dose escalation, the following solid tumors are allowed in participants who have relapsed, been non-responsive, or have developed disease progression through standard therapy and in participants for whom standard of care therapy that prolongs survival is unavailable or unsuitable (according to the Investigator and after informing the Medical Monitor): non small cell lung cancer (without driver mutations/translocations), breast cancer, endometrial cancer, thyroid cancer, kidney cancer, cholangiocarcinoma, bladder cancer, colorectal cancer, and head and neck squamous cell carcinoma.
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 not medically feasible, per Investigator, at Screening. Both fresh and archival tissue samples must be collected by core needle biopsy or surgical resection. Fine needle aspirates are not permitted.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
Participant must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 criteria (by local Investigator). Participant must have radiographic evidence of disease progression per Investigator following the most recent line of treatment.
Life expectancy of \>3 months, in the opinion of the Investigator.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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; other adequately treated Stage 1 or 2 cancers currently in complete remission; any other cancer that has been in complete remission for \>2 years or cancer of low risk of recurrence; or any treated or monitored indolent cancer that is unlikely to cause mortality in 5 years.
Known symptomatic brain metastases requiring \>10 mg/day of prednisolone (or its equivalent) at the time of signing informed consent.
Continuance of toxicities due to prior anti-cancer agents that do not recover to Grade 1 prior to start of PYX-106 treatment, except for alopecia or endocrine deficiencies treated with stable hormone replacement therapy.
Presence of Grade ≥2 peripheral neuropathy.
Major surgery within 4 weeks prior to the start of PYX-106 treatment, as defined by the Investigator.
Received palliative radiation therapy within 14 days prior to the start of PYX-106 treatment.
Received a live vaccine within 28 days prior to the first dose of study treatment and while participating in the study.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (20 Sites)

HonorHealth Research Institute — Scottsdale, Arizona
University of California San Diego — La Jolla, California
University of Southern California — Los Angeles, California
SCRI- HealthOne Denver — Denver, Colorado
Winship Cancer Institute of Emory University — Atlanta, Georgia
University of Chicago Medicine — Chicago, Illinois
Dana-Farber Cancer Institute — Boston, Massachusetts
Gabrail Cancer and Research Center — Canton, Ohio
Lifespan - Rhode Island Hospital — Providence, Rhode Island
NEXT Oncology — Irving, Texas
NEXT Virginia — Fairfax, Virginia
Universitair Ziekenhuis Leuven - Campus Gasthuisberg — Leuven, Flemish Brabant
Grand Hôpital de Charleroi - Notre Dame — Charleroi, Hainaut
Universitair Ziekenhuis Gent — Ghent, Oost-Vlaanderen
Cliniques Universitaires Saint-Luc — Brussels,
Hospital Universitari Dexeus — Barcelona, Barcelona
START Madrid - Hospital Universitario Fundación Jiménez Díaz — Madrid, Madrid
Hospital Universitario 12 de Octubre — Madrid, Madrid
HM Centro Integral Oncológico Clara Campal — Madrid, Madrid
Hospital Clínico Universitario de Valencia — Valencia, Valencia

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗