Study of PYX-106 in Solid Tumors

NCT05718557 | Active Not Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: PYX-106-1012022-002306-242023-509686-21-00
• Study Type: interventional
• Target: 47
• Locations: 3 countries
• Sites: 20

Brief Summary

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

Conditions

Solid Tumor

Keywords

Solid Tumors; Advanced Solid Tumors; PYX-106; Relapsed Solid Tumors; Refractory Solid Tumors

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• 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

Study Arms (1)

PYX-106 Dose Escalation

EXPERIMENTAL

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

Interventions

PYX-106 DRUG

Intravenous (IV) infusion

PYX-106 Dose Escalation

Eligibility Criteria

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

You may qualify if:

• Participants with histologically or cytologically confirmed solid tumors who have relapsed, been non-responsive, or have developed disease progression through standard therapy.
• 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.
• 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.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
• 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.
• Life expectancy of \>3 months, in the opinion of the Investigator.

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; 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.
• Known symptomatic brain metastases requiring \>10 mg/day of prednisolone (or its equivalent) at the time of signing informed consent.
• 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.
• Presence of Grade ≥2 peripheral neuropathy.
• Major surgery within 4 weeks prior to the start of PYX-106 treatment, as defined by the Investigator.
• Received palliative radiation therapy within 14 days prior to the start of PYX-106 treatment.
• Received a live vaccine within 28 days prior to the first dose of study treatment and while participating in the study.

Sponsors & Collaborators

• Pyxis Oncology, Inc: lead

Study Sites (20)

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

Location

University of California San Diego

La Jolla, California, 92093, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

SCRI- HealthOne Denver

Denver, Colorado, 80218, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Gabrail Cancer and Research Center

Canton, Ohio, 44718, United States

Location

Lifespan - Rhode Island Hospital

Providence, Rhode Island, 02906, United States

Location

NEXT Oncology

Irving, Texas, 75039, United States

Location

NEXT Virginia

Fairfax, Virginia, 22031, United States

Location

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, Flemish Brabant, 3000, Belgium

Location

Grand Hôpital de Charleroi - Notre Dame

Charleroi, Hainaut, 6000, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Hospital Universitari Dexeus

Barcelona, Barcelona, 08028, Spain

Location

START Madrid - Hospital Universitario Fundación Jiménez Díaz

Madrid, Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

HM Centro Integral Oncológico Clara Campal

Madrid, Madrid, 28050, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, Valencia, 46010, Spain

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 8, 2023
• Study Start: May 23, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (4); ES (5); US (11)