Clinical trial NCT05718557: Study of PYX-106 in Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Solid Tumor
Keywords: Solid Tumors
Advanced Solid Tumors
PYX-106
Relapsed Solid Tumors
Refractory Solid Tumors
Lead sponsor: Pyxis Oncology, Inc
Sponsor class: INDUSTRY
First posted: 2023-02-08
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants Who Experience a Dose-Limiting Toxicity (DLT)
timeFrame: Day 1 to Day 28
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Day 1 up to approximately 19 months
Secondary outcomes:
measure: Maximum Concentration (Cmax) of PYX-106
timeFrame: Day 1 up to approximately 2 years
measure: Time to Maximum Concentration (Tmax) of PYX-106
timeFrame: Day 1 up to approximately 2 years
measure: Area Under the Time Concentration Curve from Time 0 to the Last Quantifiable Concentration (AUC0-t) of PYX-106
timeFrame: Day 1 up to approximately 2 years
measure: Area Under the Time Concentration Curve from Time 0 to the End of the Dosing Interval (AUCtau) of PYX-106
timeFrame: Day 1 up to approximately 2 years
measure: Area Under the Time Concentration Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of PYX-106
timeFrame: Day 1 up to approximately 2 years
measure: Half Life (t1/2) of PYX-106
timeFrame: Day 1 up to approximately 2 years
measure: Objective Response Rate (ORR)
timeFrame: Day 1 up to approximately 2 years
measure: Duration of Response (DOR)
timeFrame: Day 1 up to approximately 2 years
measure: Progression Free Survival (PFS)
timeFrame: Day 1 up to approximately 2 years
measure: Disease Control Rate (DCR)
timeFrame: Day 1 up to approximately 2 years
measure: Time to Response
timeFrame: Day 1 up to approximately 2 years
measure: Overall Survival (OS)
timeFrame: Day 1 up to approximately 2 years
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth Research Institute
state: Arizona
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Denver
country: United States
facility: SCRI- HealthOne Denver
state: Colorado
city: Atlanta
country: United States
facility: Winship Cancer Institute of Emory University
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medicine
state: Illinois
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Canton
country: United States
facility: Gabrail Cancer and Research Center
state: Ohio
city: Providence
country: United States
facility: Lifespan - Rhode Island Hospital
state: Rhode Island
city: Irving
country: United States
facility: NEXT Oncology
state: Texas
city: Fairfax
country: United States
facility: NEXT Virginia
state: Virginia
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg
state: Flemish Brabant
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi - Notre Dame
state: Hainaut
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
state: Oost-Vlaanderen
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Barcelona
country: Spain
facility: Hospital Universitari Dexeus
city: Madrid
country: Spain
facility: START Madrid - Hospital Universitario Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: HM Centro Integral Oncológico Clara Campal
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
Study officials:
References: