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

JZP341-102

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

2022-12-19

2024-11-29

2024-11-29

Active (not recruiting)

Early phase I

12

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ACTUAL'}}

2024-02-29