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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-002306-24 | EudraCT Number | ||
| 2023-509686-21-00 | EU Trial (CTIS) Number |
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The primary objective of this study is to determine the recommended dose(s) of PYX-106 in participants with relapsed/refractory solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PYX-106 | Drug | Intravenous (IV) infusion |
|
| 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 |
| Measure | Description | 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 | |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research Institute | Scottsdale | Arizona | 85258 | United States | ||
| University of California San Diego |
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| 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 |
| La Jolla |
| California |
| 92093 |
| United States |
| University of Southern California | Los Angeles | California | 90033 | United States |
| SCRI- HealthOne Denver | Denver | Colorado | 80218 | United States |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | United States |
| University of Chicago Medicine | Chicago | Illinois | 60637 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Gabrail Cancer and Research Center | Canton | Ohio | 44718 | United States |
| Lifespan - Rhode Island Hospital | Providence | Rhode Island | 02906 | United States |
| NEXT Oncology | Irving | Texas | 75039 | United States |
| NEXT Virginia | Fairfax | Virginia | 22031 | United States |
| Universitair Ziekenhuis Leuven - Campus Gasthuisberg | Leuven | Flemish Brabant | 3000 | Belgium |
| Grand Hôpital de Charleroi - Notre Dame | Charleroi | Hainaut | 6000 | Belgium |
| Universitair Ziekenhuis Gent | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium |
| Hospital Universitari Dexeus | Barcelona | Barcelona | 08028 | Spain |
| START Madrid - Hospital Universitario Fundación Jiménez Díaz | Madrid | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Madrid | 28041 | Spain |
| HM Centro Integral Oncológico Clara Campal | Madrid | Madrid | 28050 | Spain |
| Hospital Clínico Universitario de Valencia | Valencia | Valencia | 46010 | Spain |