We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A JZP341 Study in Adult Participants With Advanced or Metastatic 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: NCT05631327
Recruitment Status : Recruiting
First Posted : November 30, 2022
Last Update Posted : December 22, 2022
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals

Brief Summary:
This study will assess the safety and efficacy of JZP341 in participants with advanced or metastatic solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Metastatic Solid Tumor Drug: JZP341 Phase 1

Detailed Description:

This is a first-in-human, open-label, multiple-dose, phase 1, multicenter, dose-finding study of single-agent JZP341 followed by a targeted expansion phase.

This study will have 2 phases: Dose Finding Phase and Dose Expansion Phase.

The Dose-Finding Phase will determine the recommended phase 2 dose (RP2D), assess safety and pharmacokinetics/pharmacodynamics, and explore preliminary antitumor activity of JZP341 in participants with relapsed or refractory advanced solid tumors.

The Dose-Expansion Phase will evaluate clinical activity and further evaluate the safety of multiple doses of single-agent JZP341 at the RP2D in participants with relapsed or refractory colorectal adenocarcinoma.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1, Open-Label, Dose-Finding, and Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Activity of JZP341 in Adult Participants With Advanced or Metastatic Solid Tumors
Actual Study Start Date : December 19, 2022
Estimated Primary Completion Date : November 29, 2027
Estimated Study Completion Date : November 29, 2027

Arm Intervention/treatment
Experimental: Dose Finding Phase: JZP341
Participants who will receive JZP341 on Day 1 and Day 15 of each 28-day cycle.
Drug: JZP341
JZP341 will be administered as a single, intravenous infusion over 2 hours.

Experimental: Dose Expansion Phase: JZP341
Participants who will receive JZP341 at the RP2D established in the Dose Finding Phase on Day 1 and Day 15 of each 28-day cycle.
Drug: JZP341
JZP341 will be administered as a single, intravenous infusion over 2 hours.




Primary Outcome Measures :
  1. Number of Participants With Dose-Limiting Toxicities (Dose Finding Phase) [ Time Frame: Baseline up to Day 28 ]
  2. Number of Participants With Treatment-emergent Adverse Events, by Severity (Dose Finding and Dose Expansion Phases) [ Time Frame: Baseline up to 5 years ]
  3. Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC) of JZP341 (Dose Finding Phase) [ Time Frame: Cycle 1 Day 1: (pre- and post-dose, 4 hour [hr], 8 hr), Days 2,3,4,8,11,15 (pre- and post-dose), 22, 29; Cycle 2 Day 1 (pre- and post-dose, 8 hr), Days 4,8,15 (pre- and post-dose) and 29; Cycle 3+, Days 1 (pre- and post-dose) and 15 (each cycle, 28 days) ]
  4. Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) Levels of JZP341 (Dose Finding Phase) [ Time Frame: Cycle 1 Day 1: (pre- and post-dose, 4 hour [hr], 8 hr), Days 2,3,4,8,11,15 (pre- and post-dose), 22, 29; Cycle 2 Day 1 (pre- and post-dose, 8 hr), Days 4,8,15 (pre- and post-dose) and 29; Cycle 3+, Days 1 (pre- and post-dose) and 15 (each cycle, 28 days) ]
  5. Pharmacokinetic Parameter Time to Maximum Plasma Concentration (Tmax) of JZP341 (Dose Finding Phase) [ Time Frame: Cycle 1 Day 1: (pre- and post-dose, 4 hour [hr], 8 hr), Days 2,3,4,8,11,15 (pre- and post-dose), 22, 29; Cycle 2 Day 1 (pre- and post-dose, 8 hr), Days 4,8,15 (pre- and post-dose) and 29; Cycle 3+, Days 1 (pre- and post-dose) and 15 (each cycle, 28 days) ]
  6. Pharmacokinetic Parameter Apparent Terminal Elimination Half-life (t1/2) of JZP341 (Dose Finding Phase) [ Time Frame: Cycle 1 Day 1: (pre- and post-dose, 4 hour [hr], 8 hr), Days 2,3,4,8,11,15 (pre- and post-dose), 22, 29; Cycle 2 Day 1 (pre- and post-dose, 8 hr), Days 4,8,15 (pre- and post-dose) and 29; Cycle 3+, Days 1 (pre- and post-dose) and 15 (each cycle, 28 days) ]
  7. Pharmacokinetic Parameter Clearance (CL) of JZP341 (Dose Finding Phase) [ Time Frame: Cycle 1 Day 1: (pre- and post-dose, 4 hour [hr], 8 hr), Days 2,3,4,8,11,15 (pre- and post-dose), 22, 29; Cycle 2 Day 1 (pre- and post-dose, 8 hr), Days 4,8,15 (pre- and post-dose) and 29; Cycle 3+, Days 1 (pre- and post-dose) and 15 (each cycle, 28 days) ]
  8. Pharmacokinetic Parameter Volume of Distribution (Vd) of JZP341 (Dose Finding Phase) [ Time Frame: Cycle 1 Day 1: (pre- and post-dose, 4 hour [hr], 8 hr), Days 2,3,4,8,11,15 (pre- and post-dose), 22, 29; Cycle 2 Day 1 (pre- and post-dose, 8 hr), Days 4,8,15 (pre- and post-dose) and 29; Cycle 3+, Days 1 (pre- and post-dose) and 15 (each cycle, 28 days) ]
  9. Nadir Serum Asparaginase Activity Response Rate (Dose Finding Phase) [ Time Frame: Baseline up to Day 14 ]
    Nadir serum asparaginase activity (NSAA) response rate is defined as the proportion of participants achieving NSAA ≥ 0.1 U/mL at 14 days following the first dose of JZP341 administration.

  10. Disease Control Rate (Dose Expansion Phase) [ Time Frame: Baseline up to Week 12 ]

Secondary Outcome Measures :
  1. Proportion of Participants With Hypersensitivity Reactions, Anti-Drug Antibodies, and Neutralizing Antibodies (Dose Finding and Dose Expansion Phases) [ Time Frame: Baseline up to 60 days after last dose ]
  2. Pharmacodynamic Parameter Change From Baseline in Plasma Glutamine Concentrations (Dose Finding and Dose Expansion Phases) [ Time Frame: Cycle 1 Day (Dy) 1: (pre&post, 4 hour [hr], 8hr), Dys 2 and 3 (DFP), 4, 8, 11 (DFP), 15 (pre&post), 22 (DFP), 29; Cycle 2, Dy 1:pre&post, 8hr (DFP), Dys 4&8 (DFP), 15 pre, 15 post (DFP); Cycle 3+:Dy1 pre&post, 15 (each cycle, 28 dys) ]
  3. Pharmacodynamic Parameter Change From Baseline in Plasma Asparagine Concentrations (Dose Finding and Dose Expansion Phases) [ Time Frame: Cycle 1 Day (Dy) 1: (pre&post, 4 hour [hr], 8hr), Dys 2 and 3 (DFP), 4, 8, 11 (DFP), 15 (pre&post), 22 (DFP), 29; Cycle 2, Dy 1:pre&post, 8hr (DFP), Dys 4&8 (DFP), 15 pre, 15 post (DFP); Cycle 3+:Dy1 pre&post, 15 (each cycle, 28 dys) ]
  4. Serum Asparaginase Activity of JZP341 (Dose Expansion Phase) [ Time Frame: Cycle 1, Dose 1: predose; Cycle 1, Dose 2: predose; Cycle 2 and subsequent cycles: predose on Day 1 of each cycle and at the 60-day follow-up visit (each cycle is 28 days) ]
  5. Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC) of JZP341 (Dose Expansion Phase) [ Time Frame: Cycle 1 Day 1 [pre- and post-dose, 4hour (hr), 8hr], Days 4, 8, 15 (pre- and post-dose) and 29; Cycle 2+: Days 1 (pre and post) and 15, and if last dose, Days 22 and 29 (each cycle, 28 days) ]
  6. Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) Levels of JZP341 (Dose Expansion Phase) [ Time Frame: Cycle 1 Day 1 [pre- and post-dose, 4hour (hr), 8hr], Days 4, 8, 15 (pre- and post-dose) and 29; Cycle 2+: Days 1 (pre and post) and 15, and if last dose, Days 22 and 29 (each cycle, 28 days) ]
  7. Pharmacokinetic Parameter Time to Maximum Plasma Concentration (Tmax) of JZP341 (Dose Expansion Phase) [ Time Frame: Cycle 1 Day 1 [pre- and post-dose, 4hour (hr), 8hr], Days 4, 8, 15 (pre- and post-dose) and 29; Cycle 2+: Days 1 (pre and post) and 15, and if last dose, Days 22 and 29 (each cycle, 28 days) ]
  8. Pharmacokinetic Parameter Apparent Terminal Elimination Half-life (t1/2) of JZP341 (Dose Expansion Phase) [ Time Frame: Cycle 1 Day 1 [pre- and post-dose, 4hour (hr), 8hr], Days 4, 8, 15 (pre- and post-dose) and 29; Cycle 2+: Days 1 (pre and post) and 15, and if last dose, Days 22 and 29 (each cycle, 28 days) ]
  9. Pharmacokinetic Parameter Clearance (CL) of JZP341 (Dose Expansion Phase) [ Time Frame: Cycle 1 Day 1 [pre- and post-dose, 4hour (hr), 8hr], Days 4, 8, 15 (pre- and post-dose) and 29; Cycle 2+: Days 1 (pre and post) and 15, and if last dose, Days 22 and 29 (each cycle, 28 days) ]
  10. Pharmacokinetic Parameter Volume of Distribution (Vd) of JZP341 (Dose Expansion Phase) [ Time Frame: Cycle 1 Day 1 [pre- and post-dose, 4hour (hr), 8hr], Days 4, 8, 15 (pre- and post-dose) and 29; Cycle 2+: Days 1 (pre and post) and 15, and if last dose, Days 22 and 29 (each cycle, 28 days) ]
  11. Nadir Serum Asparaginase Activity Response Rate (Dose Expansion Phase) [ Time Frame: Baseline up to Day 14 ]
    Nadir serum asparaginase activity (NSAA) response rate is defined as the proportion of participants achieving NSAA ≥ 0.1 U/mL at 14 days following the first dose of JZP341 administration.

  12. Disease Control Rate (Dose Finding Phase) [ Time Frame: Baseline up to Week 12 ]
  13. Objective Response Rate as Assessed By the Investigator (Dose Finding and Dose Expansion Phases) [ Time Frame: Baseline and then every 6 weeks from Cycle 1 Day 1 until disease progression for 24 weeks, then every 8 weeks thereafter until disease progression, withdrawal of consent, new therapy, or death (each cycle 28 days), whichever occurs first, up to 1 year ]
  14. Duration of Response as Assessed By the Investigator (Dose Finding and Dose Expansion Phases) [ Time Frame: Baseline and then every 6 weeks from Cycle 1 Day 1 until disease progression for 24 weeks, then every 8 weeks thereafter until disease progression, withdrawal of consent, new therapy, or death (each cycle 28 days), whichever occurs first, up to 1 year ]
  15. Progression-free Survival (Dose Expansion Phase) [ Time Frame: Baseline and then every 6 weeks from Cycle 1 Day 1 until disease progression for 24 weeks, then every 8 weeks thereafter until disease progression, withdrawal of consent, new therapy, or death (each cycle 28 days), whichever occurs first, up to 1 year ]
  16. Overall Survival (Dose Expansion Phase) [ Time Frame: Baseline and then every 6 weeks from Cycle 1 Day 1 until disease progression for 24 weeks, then every 8 weeks thereafter until disease progression, withdrawal of consent, new therapy, or death (each cycle 28 days), whichever occurs first, up to 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Signed informed consent form (ICF)
  • ≥ 18 years of age at the time of signing the ICF
  • Eastern Cooperative Oncology Group performance status of 0 to 2
  • Adequate bone marrow reserve
  • Adequate coagulation function, liver/pancreas function, and renal function
  • No clinically significant abnormalities in the levels of serum electrolytes
  • Life expectancy >12 weeks
  • Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 3 months after the last dose of study intervention:

    • Refrain from donating sperm, AND either:
    • Be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent, OR
    • Must agree to use an approved contraception method
  • A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:

    • Woman of non-childbearing potential (WONCBP)
    • Woman of childbearing potential (WOCBP) and using an effective contraceptive method
  • A WOCBP must have a negative highly sensitive pregnancy test within 24 hours of the first dose of study intervention

Inclusion Criteria for Dose Finding Phase Only:

  • Have a histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumor that has progressed after prior standard therapy, been intolerant to or is ineligible for standard therapy, or has a malignancy for which there is no approved therapy considered standard of care

Inclusion Criteria for Dose Expansion Phase Only:

  • Histologically or cytologically confirmed colorectal adenocarcinoma that has progressed on or is intolerant to treatment from fluoropyrimidine, oxaliplatin, and irinotecan. Participants may have received bevacizumab, anti-epidermal growth factor receptor monoclonal antibody, or checkpoint inhibitor as appropriate.
  • Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 criteria

Exclusion Criteria:

  • Primary central nervous system (CNS) tumor or symptomatic CNS metastases that are neurologically unstable or have required increasing doses of steroids within the 4 weeks prior to study entry to manage CNS symptoms (symptomatic brain metastases that have been adequately treated are not excluded)
  • Any clinically significant cardiac disease defined as New York Heart Association class III or IV within the 6 months before Screening
  • History of ≥ Grade 3 pancreatitis
  • History of intracranial thrombosis or history of recurrent thrombosis (except for catheter-related thrombosis)
  • Active (significant or uncontrolled) gastrointestinal bleeding
  • Active uncontrolled infection (≥ Grade 2) at the time of enrollment
  • HIV-positive, unless:

    • CD4+ count ≥ 300/μL;
    • Undetectable viral load; AND
    • Receiving highly active antiretroviral therapy
  • Uncontrolled infection of hepatitis B or hepatitis C or diagnosis of immunodeficiency

    • Participants with Hepatitis B who have controlled infection are permitted. Participants with controlled infections must undergo periodic monitoring of Hepatitis B virus DNA. Participants must remain on antiviral therapy for ≥ 6 months beyond the last dose of study intervention.
  • Pregnant (or plan to be pregnant) or lactating woman
  • History of any severe or uncontrolled medical condition
  • Unresolved toxicity from prior radiation, chemotherapy, or other targeted treatment, including investigational treatment, except for alopecia and Grade 1 peripheral neuropathy
  • Prior treatment with JZP341 or any other asparaginase

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): NCT05631327


Contacts
Layout table for location contacts
Contact: Clinical Trial Disclosure & Transparency 215-832-3750 ClinicalTrialDisclosure@JazzPharma.com

Locations
Layout table for location information
United States, Colorado
SCRI HealthOne Not yet recruiting
Denver, Colorado, United States, 80218
United States, Florida
Florida Cancer Specialists - Sarasota Not yet recruiting
Sarasota, Florida, United States, 34232
United States, Massachusetts
Dana Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02215
United States, New Jersey
Rutgers Cancer Institute of New Jersey Not yet recruiting
New Brunswick, New Jersey, United States, 08901
United States, Oklahoma
Oklahoma University- Oklahoma City Not yet recruiting
Oklahoma City, Oklahoma, United States, 73106
United States, Tennessee
Tennessee Oncology - Nashville Recruiting
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Jazz Pharmaceuticals
Layout table for additonal information
Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05631327    
Other Study ID Numbers: JZP341-102
First Posted: November 30, 2022    Key Record Dates
Last Update Posted: December 22, 2022
Last Verified: December 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jazz Pharmaceuticals:
Advanced Solid Tumor
Metastatic Solid Tumor
JZP341
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms