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Study of PYX-201 in Solid Tumors

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Solid Tumor Advanced Solid Tumor Drug: PYX-201 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 14, 2023
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : July 2026
Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: PYX-201
Intravenous (IV) infusion


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. Objective Response Rate (ORR) [ Time Frame: Up to approximately 3 years ]
  9. Duration of Response (DOR) [ Time Frame: Up to approximately 3 years ]
  10. Progression-free Survival (PFS) [ Time Frame: Up to approximately 3 years ]
  11. Disease Control Rate (DCR) [ Time Frame: Up to approximately 3 years ]
  12. Time to Response [ Time Frame: Up to approximately 3 years ]
  13. Overall Survival (OS) [ Time Frame: Up to approximately 3 years ]
  14. Number of Participants With Anti-drug Antibodies to PYX-201 [ Time Frame: Up to approximately 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05720117


Contacts
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Contact: Loan Vuong (339) 545 8252 clinicaltrials@pyxisoncology.com

Locations
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Sponsors and Collaborators
Pyxis Oncology, Inc
More Information
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Responsible Party: Pyxis Oncology, Inc
ClinicalTrials.gov Identifier: NCT05720117    
Other Study ID Numbers: PYX-201-101
2022-002284-30 ( EudraCT Number )
First Posted: February 9, 2023    Key Record Dates
Last Update Posted: March 22, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pyxis Oncology, Inc:
Relapsed/refractory Solid Tumor
PYX-201
Additional relevant MeSH terms:
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Neoplasms