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

NCT05631327 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: JZP341-102
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Advanced Solid Tumor; Metastatic Solid Tumor

Keywords

Advanced Solid Tumor; Metastatic Solid Tumor; JZP341

Outcome Measures

Primary Outcomes (10)

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

  Baseline up to Day 28

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

  Baseline up to 5 years

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

  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)

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

  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)

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

  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)

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

  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)

• Pharmacokinetic Parameter Clearance (CL) of JZP341 (Dose Finding Phase)

  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)

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

  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)

• 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.

  Baseline up to Day 14

• Disease Control Rate (Dose Expansion Phase)

  Baseline up to Week 12

Secondary Outcomes (16)

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

  Baseline up to 60 days after last dose

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

  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)

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

  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)

• Serum Asparaginase Activity of JZP341 (Dose Expansion Phase)

  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)

• Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC) of JZP341 (Dose Expansion Phase)

  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)

Study Arms (2)

Dose Finding Phase: JZP341

EXPERIMENTAL

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

Drug: JZP341

Dose Expansion Phase: JZP341

EXPERIMENTAL

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

Interventions

JZP341 DRUG

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

Dose Expansion Phase: JZP341; Dose Finding Phase: JZP341

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (8)

SCRI HealthOne

Denver, Colorado, 80218, United States

Location

Florida Cancer Specialists - Sarasota

Sarasota, Florida, 34232, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Oklahoma University- Oklahoma City

Oklahoma City, Oklahoma, 73106, United States

Location

Thomas Jefferson University/Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, 19107, United States

Location

Tennessee Oncology - Nashville

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: November 30, 2022
• Study Start: December 19, 2022
• Primary Completion: April 24, 2024
• Study Completion: April 24, 2024
• Last Updated: May 28, 2024

Record last verified: 2024-05

Locations

US (8)