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New treatment option for Advanced Solid Tumor
Official title JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT06108050
What this study is testing
What is JZP898?
JZP898 is an investigational medicine, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This Phase 1 first-in-human study will investigate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary antitumor activity of JZP898 monotherapy as well as JZP898 in combination with pembrolizumab in adult participants with advanced or metastatic solid tumors.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult ≥ 18 years of age
- Histological or cytological diagnosis of advanced or metastatic solid tumor.
- Previously treated participants with solid tumors that are amenable to CPI therapy (eg. NSCLC, melanoma, HNSCC, RCC, HCC, gastroesophageal...
- Parts A2 and B: previously-treated (≥ 1 line of prior anticancer therapy) participants with select tumor types (NSCLC, HNSCC, melanomas, RCC, and UC)...
- Participants in select tumor types:
You likely can't join if
- Unresolved toxicities from previous therapy that is \> 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...
- 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...
See the full eligibility criteria
- Adult ≥ 18 years of age
- Histological or cytological diagnosis of advanced or metastatic solid tumor.
- Previously treated participants with solid tumors that are amenable to CPI therapy (eg. NSCLC, melanoma, HNSCC, RCC, HCC, gastroesophageal carcinomas, UC, or CRC [MSI-H]) for whom, in the opinion of the investigator...
- 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...
- Participants in select tumor types:
- NSCLC: eligible for platinum-based therapy and received platinum-based therapy prior to inclusion in the study.
- HNSCC: eligible for platinum therapy and received platinum-based therapy prior to inclusion in this study.
- 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
- Unresolved toxicities from previous therapy that is \> 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 a stem cell/solid organ transplant.
- Receipt of prior IFNα therapy
The study team makes the final eligibility decision.
Where it's taking place
- Encinitas, California, United States
- Fresno, California, United States
- Denver, Colorado, United States
- Orlando, Florida, United States
- Durham, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Encinitas, California, United States; Fresno, California, United States; Denver, Colorado, United States; Orlando, Florida, United States; Durham, North Carolina, United States; Philadelphia, Pennsylvania, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.