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Clinical Trials in the USA / NCT05718557
Active, not recruiting Phase 1

Study of PYX-106 in Solid Tumors

NCT05718557 · tracked via the Priya Life Science USA tracker
Sponsor
Pyxis Oncology, Inc
Phase
Phase 1
Started
2023-05-23
Last updated
2025-08-03

Condition(s) studied

Solid Tumor

Investigational drug(s) / intervention(s)

PYX-106

PYX-106: Intravenous (IV) infusion

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Participants with histologically or cytologically confirmed solid tumors who have relapsed, been non-responsive, or have developed disease progression through standard therapy. 2. 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. 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 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. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1. 5. 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. 6. Life expectancy of \>3 months, in the opinion of the Investigator. Exclusion Criteria: 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; 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. 2. Known symptomatic brain metastases requiring \>10 mg/day of prednisolone (or its equivalent) at the time of signing informed consent. 3. 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. 4. Presence of Grade ≥2 peripheral neuropathy. 5. Major surgery within 4 weeks prior to the start of PYX-106 treatment, as defined by the Investigator. 6. Received palliative radiation therapy within 14 days prior to the start of PYX-106 treatment. 7. Received a live vaccine within 28 days prior to the first dose of study treatment and while participating in the study.

Primary outcome measure(s)

Trial sites (20)

FacilityCityRegionStatus
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 Belgium
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

More Pyxis Oncology, Inc trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05718557 on ClinicalTrials.gov ↗ ← All trials in the USA