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

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