Trial Title:
Study of PYX-106 in Solid Tumors
NCT ID:
NCT05718557
Condition:
Solid Tumor
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Solid Tumors
Advanced Solid Tumors
PYX-106
Relapsed Solid Tumors
Refractory Solid Tumors
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-106
Description:
Intravenous (IV) infusion
Arm group label:
PYX-106 Dose Escalation
Summary:
The primary objective of this study is to determine the recommended dose(s) of PYX-106 in
participants with relapsed/refractory solid tumors.
Criteria for eligibility:
Criteria:
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.
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:
University of California San Diego
Address:
City:
La Jolla
Zip:
92093
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Southern California
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Facility:
Name:
SCRI- HealthOne Denver
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Chicago Medicine
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Facility:
Name:
Gabrail Cancer and Research Center
Address:
City:
Canton
Zip:
44718
Country:
United States
Status:
Recruiting
Facility:
Name:
Lifespan - Rhode Island Hospital
Address:
City:
Providence
Zip:
02906
Country:
United States
Status:
Recruiting
Facility:
Name:
NEXT Oncology
Address:
City:
Irving
Zip:
75039
Country:
United States
Status:
Recruiting
Facility:
Name:
NEXT Virginia
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Grand Hôpital de Charleroi - Notre Dame
Address:
City:
Charleroi
Zip:
6000
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Universitair Ziekenhuis Gent
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Cliniques Universitaires Saint-Luc
Address:
City:
Brussels
Zip:
1200
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Hospital Universitari Dexeus
Address:
City:
Barcelona
Zip:
08028
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:
HM Centro Integral Oncológico Clara Campal
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Clínico Universitario de Valencia
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Status:
Recruiting
Start date:
May 23, 2023
Completion date:
August 2025
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/NCT05718557
