Study of PYX-201 in Solid Tumors
- Registration Number
- NCT05720117
- Lead Sponsor
- Pyxis Oncology, Inc
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
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Male or non-pregnant, non-lactating female participants age ≥18 years.
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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.
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Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
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Measurable disease according to RECIST Version 1.1.
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Life expectancy of >3 months, in the opinion of the Investigator.
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Adequate hematologic, liver and renal function.
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Available pre-treatment tumor biopsy.
- History of or concurrent invasive malignancy.
- Brain metasteses that are untreated or require current therapy.
- Significant cardiovascular disease.
- Ongoing active infection requiring systemic anti-infective therapy.
- Known active hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
- Prior solid organ or bone marrow transplantation.
- Previously received EDB+FN targeting treatments at any time prior to the start of PYX-201 treatment.
- Grade >1 neuropathy.
- History of uncontrolled diabetes mellitus.
- Participants with corneal epithelial disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PYX-201 Dose Escalation PYX-201 Participants will receive escalating doses of PYX-201 to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of PYX-201. Intra-participant dose escalation may be considered for participants who have adequately tolerated therapy.
- Primary Outcome Measures
Name Time Method Number of Participants who Experience a Dose-limiting Toxicity (DLT) Day 1 to Day 21 DLT is defined as (1) an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs after the treatment with PYX-201 and (2) meets any of the predefined criteria outlined in the protocol.
Number of Participants who Experience an Adverse Event (AE) Up to approximately 3 years Type, incidence, seriousness, relationship to study treatment and severity of AEs, including serious AEs and AEs at Grade 3 or above, based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Any clinically significant changes in clinical laboratory parameters, vital signs, and electrocardiogram (ECG) parameters will be recorded as AEs.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) Up to approximately 3 years Maximum Observed Concentration (Cmax) of PYX-201 Antibody-drug Conjugate, Total Antibody, Free Payload and Associated Metabolites in Serum Day 1 up to approximately 2 years Time to Maximum Concentration (tmax) of PYX-201 Antibody-drug Conjugate, Total Antibody, Free Payload and Associated Metabolites in Serum Day 1 up to approximately 2 years Half-life (t½) of PYX-201 Antibody-drug Conjugate, Total Antibody, Free Payload and Associated Metabolites in Serum Day 1 up to approximately 2 years Objective Response Rate (ORR) Up to approximately 3 years Progression-free Survival (PFS) Up to approximately 3 years Disease Control Rate (DCR) Up to approximately 3 years Clearance (CL) of PYX-201 Antibody-drug Conjugate, Total Antibody, Free Payload and Associated Metabolites in Serum Day 1 up to approximately 2 years Area Under the Concentration-time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-t) of PYX-201 Antibody-drug Conjugate, Total Antibody, Free Payload and Associated Metabolites in Serum Day 1 up to approximately 2 years Area Under the Concentration-time Curve Over the Dosing Interval (AUCtau) of PYX-201 Antibody-drug Conjugate, Total Antibody, Free Payload and Associated Metabolites in Serum Day 1 up to approximately 2 years Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of PYX-201 Antibody-drug Conjugate, Total Antibody, Free Payload and Associated Metabolites in Serum Day 1 up to approximately 2 years Duration of Response (DOR) Up to approximately 3 years Time to Response Up to approximately 3 years Number of Participants With Anti-drug Antibodies to PYX-201 Up to approximately 2 years
Trial Locations
- Locations (18)
SCRI - HealthOne Denver
🇺🇸Denver, Colorado, United States
University of Chicago Medicine
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
NEXT Dallas
🇺🇸Dallas, Texas, United States
NEXT Virginia
🇺🇸Fairfax, Virginia, United States
NEXT San Antonio
🇺🇸San Antonio, Texas, United States
SCRI - Florida Cancer Specialists
🇺🇸Sarasota, Florida, United States
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
START Madrid - Hospital Universitario Fundación Jiménez Díaz
🇪🇸Madrid, Spain
Hospital Clínico Universitario de Valencia
🇪🇸València, Spain
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Hospital Universitari Vall d'Hebrón
🇪🇸Barcelona, Spain
Institut Jules Bordet
🇧🇪Brussels, Belgium
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
HonorHealth Research Institute
🇺🇸Scottsdale, Arizona, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States