Actively Recruiting
A Study of PYX-201 in Advanced Solid Tumors
Led by Pyxis Oncology, Inc · Updated on 2026-03-20
330
Participants Needed
29
Research Sites
215 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objectives of this study are to determine the recommended dose(s) of PYX-201 for participants with recurrent/metastatic (R/M) solid tumors, and to determine the objective response rate (ORR) in participants treated with PYX-201 as a single agent.
CONDITIONS
Official Title
A Study of PYX-201 in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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).
- Male or non-pregnant, non-lactating female participants age 18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
- At least 1 measurable lesion per RECIST v1.1.
- Life expectancy over 3 months, based on investigator opinion.
- Corrected QTcF less than 470 msec.
- Adequate hematologic function.
- Adequate hepatic function.
- Adequate renal function.
- Adequate coagulation profile.
- Fresh tumor biopsy or archived tumor tissue sample available for clinical sites.
You will not qualify if you...
- History of another malignancy except adequately treated local basal cell or squamous cell carcinoma of the skin, in situ cervical carcinoma, or adequately treated noninvasive bladder cancer.
- Known symptomatic brain metastases.
- Significant cardiovascular disease within 6 months prior to study drug start.
- Active systemic bacterial, fungal, or viral infection requiring treatment at study drug start.
- Known active hepatitis B virus, hepatitis C virus, HIV, or AIDS.
- Failure to recover to baseline severity or Grade 1 or less NCI-CTCAE v5.0 from acute non-hematologic toxicity.
- NCI-CTCAE v5.0 Grade greater than 1 neuropathy of any cause.
- Prior solid organ or bone marrow progenitor cell transplantation.
- Prior high-dose chemotherapy requiring stem cell rescue.
- Received systemic anticancer therapy within 28 days or within 5 half-lives before study drug start.
- Palliative radiation therapy within 14 days prior to study drug start.
- Previously received EDB+FN targeting treatments before PYX-201.
- History of uncontrolled diabetes mellitus.
- History of Stevens-Johnson syndrome or toxic epidermal necrolysis.
- Corneal epithelial disease except mild punctate keratopathy.
- Best-corrected visual acuity worse than 20/100 in worst-seeing eye.
- History or current pneumonitis/interstitial lung disease requiring steroids or active pneumonitis on screening chest CT or suspected ILD/pneumonitis not ruled out by imaging.
AI-Screening
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Trial Site Locations
Total: 29 locations
1
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258
Actively Recruiting
2
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
Actively Recruiting
3
SCRI - HealthOne Denver
Denver, Colorado, United States, 80218
Actively Recruiting
4
SCRI - Florida Cancer Specialists
Sarasota, Florida, United States, 34232
Actively Recruiting
5
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30308
Actively Recruiting
6
University of Chicago Medicine
Chicago, Illinois, United States, 60637
Actively Recruiting
7
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
8
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
9
Washington University School of Medicine
St Louis, Missouri, United States, 63110-1010
Actively Recruiting
10
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
11
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
12
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19106
Actively Recruiting
13
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
14
NEXT Dallas
Dallas, Texas, United States, 75231
Actively Recruiting
15
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
16
NEXT San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
17
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
18
Institut Jules Bordet
Brussels, Brussels Capital, Belgium, 1070
Actively Recruiting
19
Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, Belgium, 1200
Actively Recruiting
20
Universitair Ziekenhuis Antwerpen
Edegem, Edegem, Belgium, 2650
Actively Recruiting
21
Universitair Ziekenhuis Gent
Ghent, Gent, Belgium, 9000
Actively Recruiting
22
Hospital Universitari Vall d'Hebrón
Barcelona, Barcelona, Spain, 08035
Actively Recruiting
23
START Madrid - Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, Spain, 28040
Actively Recruiting
24
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain, 28041
Actively Recruiting
25
Hospital Universitario HM Sanchinarro
Madrid, Madrid, Spain, 28050
Actively Recruiting
26
Hospital Clínico Universitario de Valencia
Valencia, València, Spain, 46010
Actively Recruiting
27
University College Hospital
London, England, United Kingdom, NW1 2PG
Active, Not Recruiting
28
The Royal Marsden Hospital
London, England, United Kingdom, SW3 6JJ
Active, Not Recruiting
29
Sarah Cannon Research Institute London
London, England, United Kingdom, W1G 6AD
Active, Not Recruiting
Research Team
P
Pyxis Oncology Clinical Trials Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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