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Advanced Solid TumorPhase 1NCT05631327

A JZP341 Study in Adult Participants With Advanced or Metastatic Solid Tumors

A Phase 1 study testing JZP341 in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by Jazz Pharmaceuticals at 8 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study will assess the safety and efficacy of JZP341 in participants with advanced or metastatic solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor, Metastatic Solid Tumor
What is being tested?
JZP341
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
8 sitesUnited States
Study dates
19 Dec 2022to 24 Apr 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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 72 hours of the first dose of study intervention
  • 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
  • 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

Who cannot join

  • 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
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  • 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, based on the investigator's assessment of the participant, from prior radiation, chemotherapy, or other targeted treatment, including investigational treatment, except for stable conditions ≤Grade 2 (ie, neuropathy, myalgia, fatigue, alopecia, therapy-related endocrinopathies)
  • Prior treatment with JZP341 or any other asparaginase

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • SCRI HealthOne

    Denver, Colorado, 80218

  • Tennessee Oncology - Nashville

    Nashville, Tennessee, 37203

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Oklahoma University- Oklahoma City

    Oklahoma City, Oklahoma, 73106

  • Thomas Jefferson University/Sidney Kimmel Cancer Center

    Philadelphia, Pennsylvania, 19107

  • Florida Cancer Specialists - Sarasota

    Sarasota, Florida, 34232

Other trials in United States

About this study

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

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

Read the 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.

Being tested
JZP341
Keywords
Advanced Solid Tumor, Metastatic Solid Tumor, JZP341
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JZP341Drug

    JZP341 will be administered as a single, intravenous infusion over 2 hours.

Study groups in NCT05631327
Study groupRoleWhat they receive
Dose Finding Phase: JZP341ExperimentalParticipants who will receive JZP341 on Day 1 and Day 15 of each 28-day cycle.
Receives: Drug: JZP341
Dose Expansion Phase: JZP341ExperimentalParticipants who will receive JZP341 at the RP2D established in the Dose Finding Phase on Day 1 and Day 15 of each 28-day cycle.
Receives: Drug: JZP341

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Dose-Limiting Toxicities (Dose Finding Phase)

    Measured: Baseline up to Day 28

  2. Number of Participants With Treatment-emergent Adverse Events, by Severity (Dose Finding and Dose Expansion Phases)

    Measured: Baseline up to 5 years

  3. Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC) of JZP341 (Dose Finding Phase)

    Measured: Cycle 1 Day (Dy) 1: (pre & post-dose, 4 hour [hr], 8hr), Dys 2,3,4,8,11,15 (pre & post-dose),22,29; Cycle 2 Dy 1 (pre & post-dose, 8hr), Dys 4,8,15 (pre & post-dose), 29; Cycle 3+, Dys 1 (pre & post-dose), 4hr (Cycle 3 only), and 15 (each cycle, 28 dys)

  4. Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) Levels of JZP341 (Dose Finding Phase)

    Measured: Cycle 1 Day (Dy) 1: (pre & post-dose, 4 hour [hr], 8hr), Dys 2,3,4,8,11,15 (pre & post-dose),22,29; Cycle 2 Dy 1 (pre & post-dose, 8hr), Dys 4,8,15 (pre & post-dose), 29; Cycle 3+, Dys 1 (pre & post-dose), 4hr (Cycle 3 only), and 15 (each cycle, 28 dys)

  5. Pharmacokinetic Parameter Time to Maximum Plasma Concentration (Tmax) of JZP341 (Dose Finding Phase)

    Measured: Cycle 1 Day (Dy) 1: (pre & post-dose, 4 hour [hr], 8hr), Dys 2,3,4,8,11,15 (pre & post-dose),22,29; Cycle 2 Dy 1 (pre & post-dose, 8hr), Dys 4,8,15 (pre & post-dose), 29; Cycle 3+, Dys 1 (pre & post-dose), 4hr (Cycle 3 only), and 15 (each cycle, 28 dys)

  6. Pharmacokinetic Parameter Apparent Terminal Elimination Half-life (t1/2) of JZP341 (Dose Finding Phase)

    Measured: Cycle 1 Day (Dy) 1: (pre & post-dose, 4 hour [hr], 8hr), Dys 2,3,4,8,11,15 (pre & post-dose),22,29; Cycle 2 Dy 1 (pre & post-dose, 8hr), Dys 4,8,15 (pre & post-dose), 29; Cycle 3+, Dys 1 (pre & post-dose), 4hr (Cycle 3 only), and 15 (each cycle, 28 dys)

  7. Pharmacokinetic Parameter Clearance (CL) of JZP341 (Dose Finding Phase)

    Measured: Cycle 1 Day (Dy) 1: (pre & post-dose, 4 hour [hr], 8hr), Dys 2,3,4,8,11,15 (pre & post-dose),22,29; Cycle 2 Dy 1 (pre & post-dose, 8hr), Dys 4,8,15 (pre & post-dose), 29; Cycle 3+, Dys 1 (pre & post-dose), 4hr (Cycle 3 only), and 15 (each cycle, 28 dys)

  8. Pharmacokinetic Parameter Volume of Distribution (Vd) of JZP341 (Dose Finding Phase)

    Measured: Cycle 1 Day (Dy) 1: (pre & post-dose, 4 hour [hr], 8hr), Dys 2,3,4,8,11,15 (pre & post-dose),22,29; Cycle 2 Dy 1 (pre & post-dose, 8hr), Dys 4,8,15 (pre & post-dose), 29; Cycle 3+, Dys 1 (pre & post-dose), 4hr (Cycle 3 only), and 15 (each cycle, 28 dys)

  9. Nadir Serum Asparaginase Activity Response Rate (Dose Finding Phase)

    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.

    Measured: Baseline up to Day 14

  10. Disease Control Rate (Dose Expansion Phase)

    Measured: Baseline up to Week 12

Secondary outcomes (16)

  1. Proportion of Participants With Hypersensitivity Reactions, Anti-Drug Antibodies, and Neutralizing Antibodies (Dose Finding and Dose Expansion Phases)

    Measured: Baseline up to 60 days after last dose

  2. Pharmacodynamic Parameter Change From Baseline in Plasma Glutamine Concentrations (Dose Finding and Dose Expansion Phases)

    Measured: Cycle 1 Day (Dy) 1: (pre&post, 4 hour [hr], 8hr), Dys 2&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, 4 hr (Cycle 3 DFP only), 15 (each cycle, 28 days)

  3. Pharmacodynamic Parameter Change From Baseline in Plasma Asparagine Concentrations (Dose Finding and Dose Expansion Phases)

    Measured: Cycle 1 Day (Dy) 1: (pre&post, 4 hour [hr], 8hr), Dys 2&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, 4 hr (Cycle 3 DFP only), 15 (each cycle, 28 days)

  4. Serum Asparaginase Activity of JZP341 (Dose Expansion Phase)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    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.

    Measured: Baseline up to Day 14

  12. Disease Control Rate (Dose Finding Phase)

    Measured: Baseline up to Week 12

  13. Objective Response Rate as Assessed By the Investigator (Dose Finding and Dose Expansion Phases)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2022
  2. Study start19 Dec 2022
  3. Primary completion24 Apr 2024
  4. Study completion24 Apr 2024

Why it stopped: The study was terminated based on a business decision by the Sponsor.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05631327
Sponsor's protocol ID
JZP341-102
Status last verified
May 2024
First submitted
21 Nov 2022
Last updated
28 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JZP341 in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by Jazz Pharmaceuticals at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study was terminated based on a business decision by the Sponsor.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Dose-Limiting Toxicities (Dose Finding Phase) (time frame: Baseline up to Day 28). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05631327.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.

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