a jzp341 study in adult participants with advanced or metastatic solid tumors

Conditions: Advanced Solid Tumor; Metastatic Solid Tumor

Summary: this study will assess the safety and efficacy of jzp341 in participants with advanced or metastatic solid tumors.

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.

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

Keywords: advanced solid tumor metastatic solid tumor jzp341