A Study of PYX-201 in Advanced Solid Tumors

NCT05720117 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: PYX-201-1012023-509687-14-002022-002284-30
• Study Type: interventional
• Target: 330
• Locations: 4 countries
• Sites: 29

Brief Summary

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.

Conditions

Solid Tumor; Advanced Solid Tumor

Keywords

Recurrent/Metastatic Solid Tumor; PYX-201

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (21)

• Maximum Observed Concentration (Cmax) of PYX-201 in Dose Escalation and Dose Expansion

  Day 1 up to approximately 2 years

• Time to Maximum Concentration (Tmax) of PYX-201 in Dose Escalation and Dose Expansion

  Day 1 up to approximately 2 years

• Clearance (CL) of PYX-201 in Dose Escalation

  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

  Day 1 up to approximately 2 years

• Area Under the Concentration-time Curve Over the Dosing Interval (AUCtau) of PYX-201 in Dose Escalation

  Day 1 up to approximately 2 years

Study Arms (5)

Dose Escalation

EXPERIMENTAL

Drug: PYX-201

Dose Expansion Cohort A (HNSCC)

EXPERIMENTAL

Drug: PYX-201

Dose Expansion Cohort B (TNBC)

EXPERIMENTAL

Drug: PYX-201

Dose Expansion Cohort C (HR+ HER2- BC)

EXPERIMENTAL

Drug: PYX-201

Dose Expansion Cohort D (Other Solid Tumor Types)

EXPERIMENTAL

Drug: PYX-201

Interventions

PYX-201 DRUG

Antibody-Drug Conjugate

Dose Escalation; Dose Expansion Cohort A (HNSCC); Dose Expansion Cohort B (TNBC); Dose Expansion Cohort C (HR+ HER2- BC); Dose Expansion Cohort D (Other Solid Tumor Types)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Known symptomatic brain metastases.
• Significant cardiovascular disease within 6 months prior to start of study drug.
• Evidence of an active systemic bacterial, fungal, or viral infection requiring treatment at the start of study drug.
• Known active hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
• Failure to recover to baseline severity or Grade ≤1 NCI-CTCAE v5.0 from acute non-hematologic toxicity.
• Participants with NCI-CTCAE v5.0 Grade \>1 neuropathy of any etiology.
• Prior solid organ or bone marrow progenitor cell transplantation.
• Prior high-dose chemotherapy requiring stem cell rescue.
• Received systemic anticancer therapy within 28 days or within 5 half-lives (whichever is shorter) prior to the start of study drug.
• Palliative radiation therapy within 14 days prior to the start of study drug.
• Previously received extra domain B splice variant of fibronectin (EDB+FN) targeting treatments at any time prior to the start of PYX-201 treatment.
• History of uncontrolled diabetes mellitus.
• History of Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Participants with corneal epithelial disease, with the exception of mild punctate keratopathy

Sponsors & Collaborators

• Pyxis Oncology, Inc: lead

Study Sites (29)

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

RECRUITING

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

RECRUITING

SCRI - HealthOne Denver

Denver, Colorado, 80218, United States

RECRUITING

SCRI - Florida Cancer Specialists

Sarasota, Florida, 34232, United States

RECRUITING

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30308, United States

RECRUITING

University of Chicago Medicine

Chicago, Illinois, 60637, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110-1010, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

RECRUITING

University of Pennsylvania, Abramson Cancer Center

Philadelphia, Pennsylvania, 19106, United States

RECRUITING

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

NEXT Dallas

Dallas, Texas, 75231, United States

RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

NEXT San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

NEXT Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

Institut Jules Bordet

Brussels, Brussels Capital, 1070, Belgium

RECRUITING

Cliniques Universitaires Saint-Luc

Brussels, Brussels Capital, 1200, Belgium

RECRUITING

Universitair Ziekenhuis Antwerpen

Edegem, Edegem, 2650, Belgium

RECRUITING

Universitair Ziekenhuis Gent

Ghent, Gent, 9000, Belgium

RECRUITING

Hospital Universitari Vall d'Hebrón

Barcelona, Barcelona, 08035, Spain

RECRUITING

START Madrid - Hospital Universitario Fundación Jiménez Díaz

Madrid, Madrid, 28040, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

RECRUITING

Hospital Universitario HM Sanchinarro

Madrid, Madrid, 28050, Spain

RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, València, 46010, Spain

RECRUITING

University College Hospital

London, England, NW1 2PG, United Kingdom

ACTIVE NOT RECRUITING

The Royal Marsden Hospital

London, England, SW3 6JJ, United Kingdom

ACTIVE NOT RECRUITING

Sarah Cannon Research Institute London

London, England, W1G 6AD, United Kingdom

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Pyxis Oncology Clinical Trials Team

CONTACT

(339) 545 8252; clinicaltrials@pyxisoncology.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 9, 2023
• Study Start: March 14, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (4); ES (5); US (17); GB (3)