Study of PYX-106 in Solid Tumors

A First-in-Human, Open-label, Multicenter, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PYX-106 in Subjects With Advanced Solid Tumors

The primary objective of this study is to determine the recommended dose(s) of PYX-106 in participants with relapsed/refractory solid tumors.

Study Overview

• Status: Active, not recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: PYX-106

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-luc
  • Flemish Brabant
    • Leuven, Flemish Brabant, Belgium, 3000
      • Universitair Ziekenhuis Leuven - Campus Gasthuisberg
  • Hainaut
    • Charleroi, Hainaut, Belgium, 6000
      • Grand Hôpital De Charleroi - Notre Dame
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • Universitair Ziekenhuis Gent
• Spain
  • Barcelona, Spain, 08028
    • Hospital Universitari Dexeus
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28050
    • HM Centro Integral Oncológico Clara Campal
  • Madrid, Spain, 28040
    • START Madrid - Hospital Universitario Fundacion Jimenez Diaz
  • Valencia, Spain, 46010
    • Hospital Clínico Universitario de Valencia
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • HonorHealth Research Institute
  • California
    • La Jolla, California, United States, 92093
      • University Of California San Diego
    • Los Angeles, California, United States, 90033
      • University of Southern California
  • Colorado
    • Denver, Colorado, United States, 80218
      • SCRI- HealthOne Denver
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute of Emory University
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medicine
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer and Research Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Lifespan - Rhode Island Hospital
  • Texas
    • Irving, Texas, United States, 75039
      • NEXT Oncology
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • NEXT Virginia

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PYX-106 Dose Escalation; Participants will receive escalating doses of PYX-106 to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of PYX-106, and to determine the recommended dose(s).	Drug: PYX-106; Intravenous (IV) infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Experience a Dose-Limiting Toxicity (DLT)		Day 1 to Day 28
Number of Participants Who Experience an Adverse Event (AE)	Type, incidence, seriousness and causality of AEs 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.	Day 1 up to approximately 19 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum Concentration (Cmax) of PYX-106	Day 1 up to approximately 2 years
Time to Maximum Concentration (Tmax) of PYX-106	Day 1 up to approximately 2 years
Area Under the Time Concentration Curve from Time 0 to the Last Quantifiable Concentration (AUC0-t) of PYX-106	Day 1 up to approximately 2 years
Area Under the Time Concentration Curve from Time 0 to the End of the Dosing Interval (AUCtau) of PYX-106	Day 1 up to approximately 2 years
Area Under the Time Concentration Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of PYX-106	Day 1 up to approximately 2 years
Half Life (t1/2) of PYX-106	Day 1 up to approximately 2 years
Objective Response Rate (ORR)	Day 1 up to approximately 2 years
Duration of Response (DOR)	Day 1 up to approximately 2 years
Progression Free Survival (PFS)	Day 1 up to approximately 2 years
Disease Control Rate (DCR)	Day 1 up to approximately 2 years
Time to Response	Day 1 up to approximately 2 years
Overall Survival (OS)	Day 1 up to approximately 2 years

Collaborators and Investigators

• Sponsor: Pyxis Oncology, Inc

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2023
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Actual): August 3, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Advanced Solid Tumors; Solid Tumors; Refractory Solid Tumors; Relapsed Solid Tumors; PYX-106
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: PYX-106-101; 2022-002306-24 (EudraCT Number); 2023-509686-21-00 (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