Trial Title:
Study of PYX-201 in Solid Tumors
NCT ID:
NCT05720117
Condition:
Solid Tumor
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Relapsed/refractory Solid Tumor
PYX-201
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PYX-201
Description:
Intravenous (IV) infusion
Arm group label:
PYX-201 Dose Escalation
Summary:
The primary objective of this study is to determine the recommended dose(s) of PYX-201
for participants with relapsed/refractory (R/R) solid tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or non-pregnant, non-lactating female participants age ≥18 years.
2. Histologically or cytologically confirmed solid tumors (see details below):
For the dose escalation, the following solid tumors are allowed in participants who
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), which include non-small cell lung cancer (NSCLC),
locally advanced/metastatic breast cancer including hormone receptor positive (HR+)
and negative (HR-) breast cancer, human epidermal growth factor receptor 2 negative
(HER2-) and positive (HER2+) breast cancer, triple negative breast cancer (TNBC)
head and neck squamous cell carcinomas (HNSCC), ovarian cancer, thyroid cancer,
pancreatic ductal adenocarcinoma (PDAC), soft tissue sarcoma (STS), hepatocellular
carcinoma (HCC), and kidney cancer.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
4. Measurable disease according to RECIST Version 1.1.
5. Life expectancy of >3 months, in the opinion of the Investigator.
6. Adequate hematologic, liver and renal function.
7. Available pre-treatment tumor biopsy.
Exclusion Criteria:
1. History of or concurrent invasive malignancy.
2. Brain metasteses that are untreated or require current therapy.
3. Significant cardiovascular disease.
4. Ongoing active infection requiring systemic anti-infective therapy.
5. Known active hepatitis B virus (HBV), hepatitis C virus (HCV), human
immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
6. Prior solid organ or bone marrow transplantation.
7. Previously received EDB+FN targeting treatments at any time prior to the start of
PYX-201 treatment.
8. Grade >1 neuropathy.
9. History of uncontrolled diabetes mellitus.
10. Participants with corneal epithelial disease.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
HonorHealth Research Institute
Address:
City:
Scottsdale
Zip:
85258
Country:
United States
Status:
Recruiting
Facility:
Name:
SCRI - HealthOne Denver
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Facility:
Name:
SCRI - Florida Cancer Specialists
Address:
City:
Sarasota
Zip:
34232
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Chicago Medicine
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Recruiting
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110-1010
Country:
United States
Status:
Recruiting
Facility:
Name:
Rhode Island Hospital
Address:
City:
Providence
Zip:
02903
Country:
United States
Status:
Recruiting
Facility:
Name:
NEXT Dallas
Address:
City:
Dallas
Zip:
75231
Country:
United States
Status:
Recruiting
Facility:
Name:
NEXT San Antonio
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Facility:
Name:
NEXT Virginia
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
Institut Jules Bordet
Address:
City:
Brussels
Zip:
1070
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Cliniques Universitaires Saint-Luc
Address:
City:
Brussels
Zip:
1200
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Universitair Ziekenhuis Antwerpen
Address:
City:
Edegem
Zip:
2650
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Universitair Ziekenhuis Gent
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Hospital Universitari Vall d'Hebrón
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
START Madrid - Hospital Universitario Fundación Jiménez Díaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Clínico Universitario de Valencia
Address:
City:
València
Zip:
46010
Country:
Spain
Status:
Recruiting
Start date:
March 14, 2023
Completion date:
July 2026
Lead sponsor:
Agency:
Pyxis Oncology, Inc
Agency class:
Industry
Source:
Pyxis Oncology, Inc
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05720117
