Study of PYX-106 in Solid Tumors

Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05718557
• Other study ID #: PYX-106-101
• Secondary ID: 2022-002306-24
• Status: Recruiting
• Phase: Phase 1
• Start date: May 23, 2023
• Est. completion date: August 2025

Study information

• Verified date: April 2024
• Source: Pyxis Oncology, Inc
• Contact: Chalyse Bush
• Phone: (339) 545 8252
• Email: clinicaltrials[@]pyxisoncology.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: August 2025
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 developed disease progression through standard therapy and in participants for whom standard of care therapy that prolongs survival is unavailable or unsuitable, which include 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 (the most recent available) is acceptable if fresh biopsy is not performed 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 based on RECIST criteria 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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• PYX-106
Intravenous (IV) infusion

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	Grand Hôpital de Charleroi - Notre Dame	Charleroi	Hainaut
Belgium	Universitair Ziekenhuis Gent	Gent	Oost-Vlaanderen
Spain	Hospital Universitari Dexeus	Barcelona
Spain	HM Centro Integral Oncológico Clara Campal	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	START Madrid - Hospital Universitario Fundación Jiménez Díaz	Madrid
Spain	Hospital Clínico Universitario de Valencia	Valencia
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Gabrail Cancer and Research Center	Canton	Ohio
United States	University of Chicago Medicine	Chicago	Illinois
United States	SCRI- HealthOne Denver	Denver	Colorado
United States	NEXT Virginia	Fairfax	Virginia
United States	NEXT Oncology	Irving	Texas
United States	University of California San Diego	La Jolla	California
United States	University of Southern California	Los Angeles	California
United States	HonorHealth Research Institute	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Pyxis Oncology, Inc

Countries where clinical trial is conducted

United States,  Belgium,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Experience a Dose-Limiting Toxicity (DLT)		Day 1 to Day 28
Primary	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 2 years
Secondary	Maximum Concentration (Cmax) of PYX-106		Day 1 up to approximately 2 years
Secondary	Time to Maximum Concentration (Tmax) of PYX-106		Day 1 up to approximately 2 years
Secondary	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
Secondary	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
Secondary	Area Under the Time Concentration Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of PYX-106		Day 1 up to approximately 2 years
Secondary	Half Life (t1/2) of PYX-106		Day 1 up to approximately 2 years
Secondary	Objective Response Rate (ORR)		Day 1 up to approximately 2 years
Secondary	Duration of Response (DOR)		Day 1 up to approximately 2 years
Secondary	Progression Free Survival (PFS)		Day 1 up to approximately 2 years
Secondary	Disease Control Rate (DCR)		Day 1 up to approximately 2 years
Secondary	Time to Response		Day 1 up to approximately 2 years
Secondary	Overall Survival (OS)		Day 1 up to approximately 2 years