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Study of PYX-201 in Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05720117
Recruitment Status : Recruiting
First Posted : February 9, 2023
Last Update Posted : March 22, 2024
Sponsor:
Information provided by (Responsible Party):
Pyxis Oncology, Inc

Tracking Information
First Submitted Date  ICMJE January 30, 2023
First Posted Date  ICMJE February 9, 2023
Last Update Posted Date March 22, 2024
Actual Study Start Date  ICMJE March 14, 2023
Estimated Primary Completion Date May 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2023)
  • Number of Participants who Experience a Dose-limiting Toxicity (DLT) [ Time Frame: Day 1 to Day 21 ]
    DLT is defined as (1) an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs after the treatment with PYX-201 and (2) meets any of the predefined criteria outlined in the protocol.
  • Number of Participants who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 3 years ]
    Type, incidence, seriousness, relationship to study treatment and severity of AEs, including serious AEs and AEs at Grade 3 or above, 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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2023)
  • Maximum Observed Concentration (Cmax) of PYX-201 Antibody-drug Conjugate, Total Antibody, Free Payload and Associated Metabolites in Serum [ Time Frame: Day 1 up to approximately 2 years ]
  • Time to Maximum Concentration (tmax) of PYX-201 Antibody-drug Conjugate, Total Antibody, Free Payload and Associated Metabolites in Serum [ Time Frame: Day 1 up to approximately 2 years ]
  • Clearance (CL) of PYX-201 Antibody-drug Conjugate, Total Antibody, Free Payload and Associated Metabolites in Serum [ Time Frame: Day 1 up to approximately 2 years ]
  • Area Under the Concentration-time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-t) of PYX-201 Antibody-drug Conjugate, Total Antibody, Free Payload and Associated Metabolites in Serum [ Time Frame: Day 1 up to approximately 2 years ]
  • Area Under the Concentration-time Curve Over the Dosing Interval (AUCtau) of PYX-201 Antibody-drug Conjugate, Total Antibody, Free Payload and Associated Metabolites in Serum [ Time Frame: Day 1 up to approximately 2 years ]
  • Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of PYX-201 Antibody-drug Conjugate, Total Antibody, Free Payload and Associated Metabolites in Serum [ Time Frame: Day 1 up to approximately 2 years ]
  • Half-life (t½) of PYX-201 Antibody-drug Conjugate, Total Antibody, Free Payload and Associated Metabolites in Serum [ Time Frame: Day 1 up to approximately 2 years ]
  • Objective Response Rate (ORR) [ Time Frame: Up to approximately 3 years ]
  • Duration of Response (DOR) [ Time Frame: Up to approximately 3 years ]
  • Progression-free Survival (PFS) [ Time Frame: Up to approximately 3 years ]
  • Disease Control Rate (DCR) [ Time Frame: Up to approximately 3 years ]
  • Time to Response [ Time Frame: Up to approximately 3 years ]
  • Overall Survival (OS) [ Time Frame: Up to approximately 3 years ]
  • Number of Participants With Anti-drug Antibodies to PYX-201 [ Time Frame: Up to approximately 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of PYX-201 in Solid Tumors
Official Title  ICMJE A First-in-Human, Open-label, Multicenter, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PYX-201 in Participants With Advanced Solid Tumors
Brief Summary The primary objective of this study is to determine the recommended dose(s) of PYX-201 for participants with relapsed/refractory (R/R) solid tumors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumor
  • Advanced Solid Tumor
Intervention  ICMJE Drug: PYX-201
Intravenous (IV) infusion
Study Arms  ICMJE Experimental: PYX-201 Dose Escalation
Participants will receive escalating doses of PYX-201 to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of PYX-201. Intra-participant dose escalation may be considered for participants who have adequately tolerated therapy.
Intervention: Drug: PYX-201
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 8, 2023)		 45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2026
Estimated Primary Completion Date May 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or non-pregnant, non-lactating female participants age ≥18 years.

  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 (according to the Investigator), which include non-small cell lung cancer (NSCLC), head and neck squamous cell carcinomas (HNSCC), locally advanced/metastatic breast cancer including hormone receptor (HR) positive (HR+) and negative (HR-) breast cancer, human epidermal growth factor receptor 2 (HER2) negative (HER2-) and positive (HER2+) breast cancer, and triple negative breast cancer (TNBC), ovarian cancer, thyroid cancer, pancreatic ductal adenocarcinoma (PDAC), soft tissue sarcoma (STS), hepatocellular carcinoma (HCC), and kidney cancer.

  3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
  4. Participant must have at least 1 measurable lesion Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (by local Investigator) except participants with bone-only metastatic breast cancer (mBC) who can be enrolled without measurable disease. Participant must have radiographic evidence of disease progression based on RECIST criteria following the most recent line of treatment.
  5. Life expectancy of >3 months, in the opinion of the Investigator.
  6. Clinical sites must conduct fresh tumor biopsy (formalin-fixed, paraffin-embedded [FFPE]) or provide participants' archived tissue; 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-201) 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.

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, noninvasive bladder cancer; other adequately treated Stage 1 or 2 cancers currently in complete remission; or any other cancer that has been in complete remission for >2 years or cancer of low risk of recurrence if agreed to by the medical monitor, except 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. Participants with previously diagnosed brain metastases are eligible if they have completed their treatment, have recovered from the acute effects of radiation therapy or surgery prior to the start of PYX-201 treatment, fulfill the steroid requirement for these metastases, and are neurologically stable based on central nervous system imaging ≥4 weeks after treatment.
  3. Evidence of an active systemic bacterial, fungal, or viral infection requiring treatment at the start of PYX-201 treatment.
  4. Major surgery within 4 weeks prior to the start of PYX-201 treatment, as defined by the Investigator.
  5. Prior solid organ or bone marrow progenitor cell transplantation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Loan Vuong (339) 545 8252 clinicaltrials@pyxisoncology.com
Listed Location Countries  ICMJE Belgium,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05720117
Other Study ID Numbers  ICMJE PYX-201-101
2022-002284-30 ( EudraCT Number )
Has Data Monitoring Committee No
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  ICMJE
Plan to Share IPD: No
Current Responsible Party Pyxis Oncology, Inc
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Pyxis Oncology, Inc
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pyxis Oncology, Inc
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP