JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid Tumors

Launched by JAZZ PHARMACEUTICALS · Oct 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called JZP898, which is being given alone or alongside another medication called pembrolizumab to see how safe it is and how well it works for adults with advanced or metastatic solid tumors, which are types of cancers that have spread beyond their original location. The trial is currently looking for participants who are 18 years or older and have been diagnosed with certain types of solid tumors that have not responded well to other treatments. Eligible patients may include those with lung cancer, melanoma, or certain other cancers, provided they have already received specific prior therapies and meet other health criteria.

Participants in the trial can expect to receive infusions of JZP898 and may need to undergo some tests and procedures, including biopsies of their tumors. The study aims to gather information about how the treatment affects the cancer and to monitor any side effects. It’s important for potential participants to know that there are strict guidelines about who can join the study, especially concerning their health history and current conditions. If you or someone you know is interested in participating, it's a good idea to talk with a healthcare provider for more information.

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Eligibility criteria

• • Inclusion Criteria
• • Adult ≥ 18 years of age
• • Histological or cytological diagnosis of advanced or metastatic solid tumor.
• • 1. Previously treated participants with solid tumors (eg. NSCLC, melanoma, HNSCC, RCC, HCC, gastroesophageal carcinomas, UC, or CRC \[MSI-H\]) for whom, in the opinion of the investigator, there is no SoC available to convey clinical benefit.
• • 2. Parts A2 and B: previously-treated (≥ 1 line of prior anticancer therapy) participants with select tumor types (NSCLC, HNSCC, melanomas, RCC, and UC) who have progressed on/after prior CPI therapy based on investigator assessment per RECIST version 1.1.
• * Participants in select tumor types:
• • 1. NSCLC: eligible for platinum-based therapy and received platinum-based therapy prior to inclusion in the study.
• • 2. HNSCC: eligible for platinum therapy and received platinum-based therapy prior to inclusion in this study.
• • 3. Melanoma with known BRAFv600 mutation: received BRAF/MEKi therapy before this study.
• • ECOG score of 0 to 1.
• • Measurable disease per RECIST version 1.1 criteria.
• • Parts A1 and A2 only: willing to consent to mandatory tumor biopsies (both pretreatment and post-treatment with JZP898) unless medically infeasible
• • Adequate organ and bone marrow function as indicated by the following laboratory values (within 4 weeks prior to starting the study interventions)
• • Men and women of reproductive potential to observe highly effective birth control for the duration of treatment and for 4 months following the last dose of study drug;
• • Additional criteria may apply
• • Exclusion Criteria
• • Unresolved toxicities \> Grade 1.
• • Hypersensitivity to mAb, IFNα, or study intervention components.
• • Primary CNS tumor or symptomatic CNS metastases.
• • Have a second primary malignancy treated within the previous 2 years (exceptions: non-metastatic, non-melanomatous skin cancers, carcinoma in-situ, and melanoma in-situ).
• • Active autoimmune disease (in the last 2 years) requiring systemic steroids or immunosuppressive agents.
• • Active or history of pneumonitis (noninfectious) or interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
• • Any history of suicidal behavior or any suicidal ideation
• • Clinically significant ischemic/hemorrhagic cerebrovascular accident/stroke and/or clinically significant active cardiovascular disease
• • Received any anticancer therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of study drug
• • Received prior radiotherapy within 2 weeks of the first dose of study drug or have had a history of radiation pneumonitis
• • Major surgery within 2 weeks prior to the first dose of study intervention.
• • Participant is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study
• • Had an allogeneic tissue/solid organ transplant.
• • Receipt of prior IFNα therapy