Study of PYX-106 in Solid Tumors

NCT ID: NCT05718557

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-23
• Study Completion Date: 2026-05-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

PYX-106

Intervention Type: DRUG

Intravenous (IV) infusion

Interventions

PYX-106

Intravenous (IV) infusion

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pyxis Oncology, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

HonorHealth Research Institute

Scottsdale, Arizona, United States

University of California San Diego

La Jolla, California, United States

University of Southern California

Los Angeles, California, United States

SCRI- HealthOne Denver

Denver, Colorado, United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

University of Chicago Medicine

Chicago, Illinois, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Gabrail Cancer and Research Center

Canton, Ohio, United States

Lifespan - Rhode Island Hospital

Providence, Rhode Island, United States

NEXT Oncology

Irving, Texas, United States

NEXT Virginia

Fairfax, Virginia, United States

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, Flemish Brabant, Belgium

Grand Hôpital de Charleroi - Notre Dame

Charleroi, Hainaut, Belgium

Universitair Ziekenhuis Gent

Ghent, Oost-Vlaanderen, Belgium

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Hospital Universitari Dexeus

Barcelona, Barcelona, Spain

START Madrid - Hospital Universitario Fundación Jiménez Díaz

Madrid, Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

HM Centro Integral Oncológico Clara Campal

Madrid, Madrid, Spain

Hospital Clínico Universitario de Valencia

Valencia, Valencia, Spain

Countries

United States; Belgium; Spain

Other Identifiers

2022-002306-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-509686-21-00

Identifier Type: CTIS

Identifier Source: secondary_id

PYX-106-101

Identifier Type: -

Identifier Source: org_study_id