Study of PYX-106 in Solid Tumors

• ClinicalTrials.gov Identifier: NCT05718557
• Recruitment Status: Recruiting
• First Posted: February 8, 2023
• Last Update Posted: April 5, 2024
• Sponsor: Pyxis Oncology, Inc
• Information provided by (Responsible Party): Pyxis Oncology, Inc

Tracking Information

• First Submitted Date: January 30, 2023
• First Posted Date: February 8, 2023
• Last Update Posted Date: April 5, 2024
• Actual Study Start Date: May 23, 2023
• Estimated Primary Completion Date: April 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 30, 2023)

• Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) [ Time Frame: Day 1 to Day 28 ]
• Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Day 1 up to approximately 2 years ]
  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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 30, 2023)

• Maximum Concentration (Cmax) of PYX-106 [ Time Frame: Day 1 up to approximately 2 years ]
• Time to Maximum Concentration (Tmax) of PYX-106 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 1 up to approximately 2 years ]
• Area Under the Time Concentration Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of PYX-106 [ Time Frame: Day 1 up to approximately 2 years ]
• Half Life (t1/2) of PYX-106 [ Time Frame: Day 1 up to approximately 2 years ]
• Objective Response Rate (ORR) [ Time Frame: Day 1 up to approximately 2 years ]
• Duration of Response (DOR) [ Time Frame: Day 1 up to approximately 2 years ]
• Progression Free Survival (PFS) [ Time Frame: Day 1 up to approximately 2 years ]
• Disease Control Rate (DCR) [ Time Frame: Day 1 up to approximately 2 years ]
• Time to Response [ Time Frame: Day 1 up to approximately 2 years ]
• Overall Survival (OS) [ Time Frame: Day 1 up to approximately 2 years ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Solid Tumor

Intervention

Drug: PYX-106

Intravenous (IV) infusion

Study Arms

Experimental: 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).

Intervention: Drug: PYX-106

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 30, 2023): 45
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 2025
• Estimated Primary Completion Date: April 2024 (Final data collection date for primary outcome measure)

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 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Chalyse Bush; (339) 545 8252; clinicaltrials@pyxisoncology.com

• Listed Location Countries: Belgium, Spain, United States

Administrative Information

• NCT Number: NCT05718557
• Other Study ID Numbers: PYX-106-101; 2022-002306-24 ( EudraCT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Pyxis Oncology, Inc
• Original Responsible Party: Same as current
• Current Study Sponsor: Pyxis Oncology, Inc
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Pyxis Oncology, Inc
• Verification Date: April 2024