A Study of PYX-201 in Advanced Solid Tumors

A First-in-Human, Open-label, Multicenter, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PYX-201 in Participants With Advanced Solid Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor; Advanced Solid Tumor
• Intervention / Treatment: Drug: PYX-201

• Study Type: Interventional
• Enrollment (Estimated): 330
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Pyxis Oncology Clinical Trials Team; Phone Number: (339) 545 8252; Email: clinicaltrials@pyxisoncology.com

Study Locations

• Belgium
  • Brussels Capital
    • Brussels, Brussels Capital, Belgium, 1200
      • Recruiting
      • Cliniques Universitaires Saint-luc
    • Brussels, Brussels Capital, Belgium, 1070
      • Recruiting
      • Institut Jules Bordet
  • Edegem
    • Edegem, Edegem, Belgium, 2650
      • Recruiting
      • Universitair Ziekenhuis Antwerpen
  • Gent
    • Ghent, Gent, Belgium, 9000
      • Recruiting
      • Universitair Ziekenhuis Gent
• Spain
  • Barcelona
    • Barcelona, Barcelona, Spain, 08035
      • Recruiting
      • Hospital Universitari Vall d'Hebron
  • Madrid
    • Madrid, Madrid, Spain, 28041
      • Recruiting
      • Hospital Universitario 12 de Octubre
    • Madrid, Madrid, Spain, 28040
      • Recruiting
      • START Madrid - Hospital Universitario Fundacion Jimenez Diaz
    • Madrid, Madrid, Spain, 28050
      • Recruiting
      • Hospital Universitario HM Sanchinarro
  • València
    • Valencia, València, Spain, 46010
      • Recruiting
      • Hospital Clínico Universitario de Valencia
• United Kingdom
  • England
    • London, England, United Kingdom, W1G 6AD
      • Active, not recruiting
      • Sarah Cannon Research Institute London
    • London, England, United Kingdom, NW1 2PG
      • Active, not recruiting
      • University College Hospital
    • London, England, United Kingdom, SW3 6JJ
      • Active, not recruiting
      • The Royal Marsden Hospital
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Recruiting
      • HonorHealth Research Institute
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • Ronald Reagan UCLA Medical Center
  • Colorado
    • Denver, Colorado, United States, 80218
      • Recruiting
      • SCRI - HealthOne Denver
  • Florida
    • Sarasota, Florida, United States, 34232
      • Recruiting
      • SCRI - Florida Cancer Specialists
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Recruiting
      • Winship Cancer Institute, Emory University
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago Medicine
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
  • Missouri
    • St Louis, Missouri, United States, 63110-1010
      • Recruiting
      • Washington University School of Medicine
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • University of Cincinnati Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19106
      • Recruiting
      • University of Pennsylvania, Abramson Cancer Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Rhode Island Hospital
  • Texas
    • Dallas, Texas, United States, 75231
      • Recruiting
      • NEXT Dallas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas MD Anderson Cancer Center
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • NEXT San Antonio
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • NEXT Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion

1. 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).
2. Male or non-pregnant, non-lactating female participants age ≥18 years.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1.
4. Participant must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
5. Life expectancy of >3 months, in the opinion of the Investigator.
6. Corrected QTcF <470 msec.
7. Adequate hematologic function.
8. Adequate hepatic function.
9. Adequate renal function.
10. Adequate coagulation profile.
11. Clinical sites must conduct fresh tumor biopsy or provide participant's archived tumor tissue sample.

Exclusion

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, noninvasive bladder cancer.
2. Known symptomatic brain metastases.
3. Significant cardiovascular disease within 6 months prior to start of study drug.
4. Evidence of an active systemic bacterial, fungal, or viral infection requiring treatment at the start of study drug.
5. Known active hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
6. Failure to recover to baseline severity or Grade ≤1 NCI-CTCAE v5.0 from acute non-hematologic toxicity.
7. Participants with NCI-CTCAE v5.0 Grade >1 neuropathy of any etiology.
8. Prior solid organ or bone marrow progenitor cell transplantation.
9. Prior high-dose chemotherapy requiring stem cell rescue.
10. Received systemic anticancer therapy within 28 days or within 5 half-lives (whichever is shorter) prior to the start of study drug.
11. Palliative radiation therapy within 14 days prior to the start of study drug.
12. Previously received extra domain B splice variant of fibronectin (EDB+FN) targeting treatments at any time prior to the start of PYX-201 treatment.
13. History of uncontrolled diabetes mellitus.
14. History of Stevens-Johnson syndrome or toxic epidermal necrolysis.
15. Participants with corneal epithelial disease, with the exception of mild punctate keratopathy
16. Participants with the best-corrected visual acuity in the worst-seeing eye worse than 20/100 (Snellen equivalent).
17. Participants with a history of (noninfectious) pneumonitis/ interstitial lung disease that required steroids, has current pneumonitis/ interstitial lung disease, or evidence of active pneumonitis on screening chest CT scan or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Escalation	Drug: PYX-201; Antibody-Drug Conjugate
Experimental: Dose Expansion Cohort A (HNSCC)	Drug: PYX-201; Antibody-Drug Conjugate
Experimental: Dose Expansion Cohort B (TNBC)	Drug: PYX-201; Antibody-Drug Conjugate
Experimental: Dose Expansion Cohort C (HR+ HER2- BC)	Drug: PYX-201; Antibody-Drug Conjugate
Experimental: Dose Expansion Cohort D (Other Solid Tumor Types)	Drug: PYX-201; Antibody-Drug Conjugate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants who Experience a Dose-limiting Toxicity (DLT) in Dose Escalation	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.	Day 1 to Day 21
Safety and Tolerability as assessed by adverse event monitoring for participants in Dose Escalation	Adverse Events as characterized by type, incidence, seriousness, relationship to study treatment, timing, and severity (as graded by NCI-CTCAE Version 5.0). Any clinically significant changes in clinical laboratory parameters, vital signs, and electrocardiogram (ECG) parameters will be recorded as AEs.	Up to approximately 3 years
Objective Response Rate (ORR) observed in participants in Dose Expansion		Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Concentration (Cmax) of PYX-201 in Dose Escalation and Dose Expansion	Pharmacokinetic (PK) assessments for PYX-201	Day 1 up to approximately 2 years
Time to Maximum Concentration (Tmax) of PYX-201 in Dose Escalation and Dose Expansion	Pharmacokinetic (PK) assessments for PYX-201	Day 1 up to approximately 2 years
Clearance (CL) of PYX-201 in Dose Escalation	Pharmacokinetic (PK) assessments for PYX-201	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 in Dose Escalation	Pharmacokinetic (PK) assessments for PYX-201	Day 1 up to approximately 2 years
Area Under the Concentration-time Curve Over the Dosing Interval (AUCtau) of PYX-201 in Dose Escalation	Pharmacokinetic (PK) assessments for PYX-201	Day 1 up to approximately 2 years
Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of PYX-201 in Dose Escalation	Pharmacokinetic (PK) assessments for PYX-201	Day 1 up to approximately 2 years
Half-life (t½) of PYX-201 in Dose Escalation	Pharmacokinetic (PK) assessments for PYX-201	Day 1 up to approximately 2 years
Objective Response Rate (ORR) observed in participants in Dose Escalation		Up to approximately 3 years
Duration of Response (DOR) observed in participants in Dose Escalation and Dose Expansion		Up to approximately 3 years
Progression-free Survival (PFS) observed in participants in Dose Escalation		Up to approximately 3 years
Disease Control Rate (DCR) observed in participants in Dose Escalation and Dose Expansion		Up to approximately 3 years
Time to Response (TTR) observed in participants in Dose Escalation and Dose Expansion		Up to approximately 3 years
Overall Survival (OS) observed in participants in Dose Escalation		Up to approximately 3 years
Incidence of Anti-drug Antibodies (ADA) in participants treated with PYX-201 in Dose Escalation and Dose Expansion		Up to approximately 2 years
Clinical Benefit Rate (CBR) observed in participants in Dose Expansion		Up to approximately 2 years
Median Progression-free Survival (mPFS) observed in participants in Dose Expansion		Up to approximately 4 years
Median Overall Survival (mOS) observed in participants in Dose Expansion		Up to approximately 4 years
Cmax of PYX-201 in Dose Expansion	Pharmacokinetic (PK) assessments for PYX-201	Up to approximately 2 years
Tmax of PYX-201 in Dose Expansion	Pharmacokinetic (PK) assessments for PYX-201	Up to approximately 2 years
Trough Concentration of PYX-201 in Dose Expansion	Pharmacokinetic (PK) assessments for PYX-201	Up to approximately 2 years
Safety and Tolerability as assessed by adverse event monitoring for participants in Dose Expansion	Adverse Events characterized by type, incidence, seriousness, relationship to study treatment, timing, and severity (as graded by NCI-CTCAE Version 5.0). Any clinically significant changes in clinical laboratory parameters, vital signs, and ECG parameters will be recorded as AEs.	Up to approximately 2 years

Collaborators and Investigators

• Sponsor: Pyxis Oncology, Inc

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 9, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: PYX-201; Recurrent/Metastatic Solid Tumor
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis
• Other Study ID Numbers: PYX-201-101; 2022-002284-30 (EudraCT Number); 2023-509687-14-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No