A JZP341 Study 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.

Inclusion Criteria:Signed informed consent form (ICF)≥ 18 years of age at the time of signing the ICFEastern Cooperative Oncology Group performance status of 0 to 2Adequate bone marrow reserveAdequate coagulation function, liver/pancreas function, and renal functionNo clinically significant abnormalities in the levels of serum electrolytesLife expectancy >12 weeksMale 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, ORMust agree to use an approved contraception methodA 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 methodA WOCBP must have a negative highly sensitive pregnancy test within 24 hours of the first dose of study interventionInclusion 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 careInclusion 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 criteriaExclusion 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 ScreeningHistory of ≥ Grade 3 pancreatitisHistory of intracranial thrombosis or history of recurrent thrombosis (except for catheter-related thrombosis)Active (significant or uncontrolled) gastrointestinal bleedingActive uncontrolled infection (≥ Grade 2) at the time of enrollmentHIV-positive, unless:CD4+ count ≥ 300/μL;Undetectable viral load; ANDReceiving highly active antiretroviral therapyUncontrolled infection of hepatitis B or hepatitis C or diagnosis of immunodeficiencyParticipants 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 womanHistory of any severe or uncontrolled medical conditionUnresolved toxicity from prior radiation, chemotherapy, or other targeted treatment, including investigational treatment, except for alopecia and Grade 1 peripheral neuropathyPrior treatment with JZP341 or any other asparaginase