Study of PYX-201 in Solid Tumors
- Registration Number
- NCT05720117
- Lead Sponsor
- Pyxis Oncology, Inc
- Brief Summary
The primary objectives of this study are to determine the recommended dose(s) of PYX-201 for participants with relapsed/refractory (R/R) solid tumors, and to determine the objective response rate (ORR) in participants treated with PYX-201 as a single agent.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: PYX-201 Dose Escalation PYX-201 Participants will receive escalating doses of PYX-201 as an intravenous (IV) infusion 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. Part 2: Cohort A PYX-201 Participants with recurrent, persistent, and/or metastatic head and neck squamous cell carcinoma (HNSCC) who have received at least one but no more than two lines of prior systemic therapy, including platinum-based therapy and a programmed cell death protein 1 (PD-1) inhibitor, and participants who have received up to two lines of prior therapy that must include one prior PD-1 inhibitor and one prior epidermal growth factor receptor (EGFR)-directed treatment, will receive PYX-201 as an IV infusion at the recommended dose for Part 2. Part 2: Cohort B PYX-201 Participants with triple-negative breast cancer (TNBC) who have been treated with at least one but no more than two lines of prior systemic therapy will receive PYX-201 as an IV infusion at the recommended dose for Part 2. Part 2: Cohort C PYX-201 Participants with hormone receptor (HR)-positive (HR+)/human epidermal growth factor receptor 2 (HER2)-negative (immunohistochemistry \[IHC\] 0, IHC 1+, or IHC 2+/in situ hybridization \[ISH\]-negative) breast cancer who had progressed on cyclin-dependent kinase 4/6 (CDK-4/6) inhibitors plus endocrine therapy and one line of chemotherapy, and had received no more than three prior lines of systemic therapy, will receive PYX-201 as an IV infusion at the recommended dose for Part 2. Part 2: Cohort D PYX-201 Participants with various advanced solid tumor types, including non-small cell lung cancer (NSCLC), sarcomas, rare solid tumor head and neck (H\&N) cancers, ovarian cancer (OVCA), cervical cancer, and endometrial cancer, will receive PYX-201 as an IV infusion at the recommended dose for Part 2.
- Primary Outcome Measures
Name Time Method Part 1: 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.
Part 1: Number of Participants who Experience an 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.
Part 2: Objective Response Rate (ORR) Up to approximately 2 years
- Secondary Outcome Measures
Name Time Method Part 2: TTR Up to approximately 2 years Part 2: Median Overall Survival (mOS) Up to approximately 4 years Part 2: Cmax of PYX-201 Up to approximately 2 years Part 2: Tmax of PYX-201 Up to approximately 2 years Part 2: Trough Concentration of PYX-201 Up to approximately 2 years Part 2: Number of Participants who Experience an AE Up to approximately 2 years Type, incidence, seriousness, relationship to study treatment and severity of AEs, including serious AEs and AEs at Grade 3 or above, based on NCI-CTCAE Version 5.0. Any clinically significant changes in clinical laboratory parameters, vital signs, and ECG parameters will be recorded as AEs.
Part 2: Median Progression-free Survival (mPFS) Up to approximately 4 years Part 2: DCR Up to approximately 2 years Part 1: 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 Part 1: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 Part 1:Clearance (CL) of PYX-201 Antibody-drug Conjugate, Total Antibody, Free Payload and Associated Metabolites in Serum Day 1 up to approximately 2 years Part 1: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 Part 1: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 Part 1: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 Part 1: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 Part 1: ORR Up to approximately 3 years Part 1:Duration of Response (DOR) Up to approximately 3 years Part 1:Progression-free Survival (PFS) Up to approximately 3 years Part 1:Disease Control Rate (DCR) Up to approximately 3 years Part 1:Time to Response (TTR) Up to approximately 3 years Part 1:Overall Survival (OS) Up to approximately 3 years Part 1:Number of Participants With Anti-drug Antibodies to PYX-201 Up to approximately 2 years Part 2: DOR Up to approximately 2 years Part 2: Clinical Benefit Rate 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