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

Primary Purpose

Advanced Solid Tumor, Metastatic Solid Tumor

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
JZP341
Sponsored by
Jazz Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Solid Tumor focused on measuring Advanced Solid Tumor, Metastatic Solid Tumor, JZP341

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 72 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, 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

Sites / Locations

  • SCRI HealthOneRecruiting
  • Florida Cancer Specialists - SarasotaRecruiting
  • University of Maryland Medical Center
  • Dana Farber Cancer Institute
  • Rutgers Cancer Institute of New JerseyRecruiting
  • Oklahoma University- Oklahoma CityRecruiting
  • Thomas Jefferson University/Sidney Kimmel Cancer CenterRecruiting
  • Tennessee Oncology - NashvilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dose Finding Phase: JZP341

Dose Expansion Phase: JZP341

Arm Description

Participants who will receive JZP341 on Day 1 and Day 15 of each 28-day cycle.

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.

Outcomes

Primary Outcome Measures

Number of Participants With Dose-Limiting Toxicities (Dose Finding Phase)
Number of Participants With Treatment-emergent Adverse Events, by Severity (Dose Finding and Dose Expansion Phases)
Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC) of JZP341 (Dose Finding Phase)
Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) Levels of JZP341 (Dose Finding Phase)
Pharmacokinetic Parameter Time to Maximum Plasma Concentration (Tmax) of JZP341 (Dose Finding Phase)
Pharmacokinetic Parameter Apparent Terminal Elimination Half-life (t1/2) of JZP341 (Dose Finding Phase)
Pharmacokinetic Parameter Clearance (CL) of JZP341 (Dose Finding Phase)
Pharmacokinetic Parameter Volume of Distribution (Vd) of JZP341 (Dose Finding Phase)
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.
Disease Control Rate (Dose Expansion Phase)

Secondary Outcome Measures

Proportion of Participants With Hypersensitivity Reactions, Anti-Drug Antibodies, and Neutralizing Antibodies (Dose Finding and Dose Expansion Phases)
Pharmacodynamic Parameter Change From Baseline in Plasma Glutamine Concentrations (Dose Finding and Dose Expansion Phases)
Pharmacodynamic Parameter Change From Baseline in Plasma Asparagine Concentrations (Dose Finding and Dose Expansion Phases)
Serum Asparaginase Activity of JZP341 (Dose Expansion Phase)
Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC) of JZP341 (Dose Expansion Phase)
Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) Levels of JZP341 (Dose Expansion Phase)
Pharmacokinetic Parameter Time to Maximum Plasma Concentration (Tmax) of JZP341 (Dose Expansion Phase)
Pharmacokinetic Parameter Apparent Terminal Elimination Half-life (t1/2) of JZP341 (Dose Expansion Phase)
Pharmacokinetic Parameter Clearance (CL) of JZP341 (Dose Expansion Phase)
Pharmacokinetic Parameter Volume of Distribution (Vd) of JZP341 (Dose Expansion Phase)
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.
Disease Control Rate (Dose Finding Phase)
Objective Response Rate as Assessed By the Investigator (Dose Finding and Dose Expansion Phases)
Duration of Response as Assessed By the Investigator (Dose Finding and Dose Expansion Phases)
Progression-free Survival (Dose Expansion Phase)
Overall Survival (Dose Expansion Phase)

Full Information

First Posted
November 21, 2022
Last Updated
October 17, 2023
Sponsor
Jazz Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05631327
Brief Title
A JZP341 Study in Adult Participants With Advanced or Metastatic Solid Tumors
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 19, 2022 (Actual)
Primary Completion Date
November 29, 2027 (Anticipated)
Study Completion Date
November 29, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jazz Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumor, Metastatic Solid Tumor
Keywords
Advanced Solid Tumor, Metastatic Solid Tumor, JZP341

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Finding Phase: JZP341
Arm Type
Experimental
Arm Description
Participants who will receive JZP341 on Day 1 and Day 15 of each 28-day cycle.
Arm Title
Dose Expansion Phase: JZP341
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
JZP341
Intervention Description
JZP341 will be administered as a single, intravenous infusion over 2 hours.
Primary Outcome Measure Information:
Title
Number of Participants With Dose-Limiting Toxicities (Dose Finding Phase)
Time Frame
Baseline up to Day 28
Title
Number of Participants With Treatment-emergent Adverse Events, by Severity (Dose Finding and Dose Expansion Phases)
Time Frame
Baseline up to 5 years
Title
Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC) of JZP341 (Dose Finding Phase)
Time Frame
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)
Title
Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) Levels of JZP341 (Dose Finding Phase)
Time Frame
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)
Title
Pharmacokinetic Parameter Time to Maximum Plasma Concentration (Tmax) of JZP341 (Dose Finding Phase)
Time Frame
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)
Title
Pharmacokinetic Parameter Apparent Terminal Elimination Half-life (t1/2) of JZP341 (Dose Finding Phase)
Time Frame
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)
Title
Pharmacokinetic Parameter Clearance (CL) of JZP341 (Dose Finding Phase)
Time Frame
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)
Title
Pharmacokinetic Parameter Volume of Distribution (Vd) of JZP341 (Dose Finding Phase)
Time Frame
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)
Title
Nadir Serum Asparaginase Activity Response Rate (Dose Finding Phase)
Description
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.
Time Frame
Baseline up to Day 14
Title
Disease Control Rate (Dose Expansion Phase)
Time Frame
Baseline up to Week 12
Secondary Outcome Measure Information:
Title
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
Title
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&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)
Title
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&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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
Nadir Serum Asparaginase Activity Response Rate (Dose Expansion Phase)
Description
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.
Time Frame
Baseline up to Day 14
Title
Disease Control Rate (Dose Finding Phase)
Time Frame
Baseline up to Week 12
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 72 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, 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trial Disclosure & Transparency
Phone
215-832-3750
Email
ClinicalTrialDisclosure@JazzPharma.com
Facility Information:
Facility Name
SCRI HealthOne
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists - Sarasota
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Name
Oklahoma University- Oklahoma City
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73106
Country
United States
Individual Site Status
Recruiting
Facility Name
Thomas Jefferson University/Sidney Kimmel Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Oncology - Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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