Status:
RECRUITING
JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid Tumors
Lead Sponsor:
Jazz Pharmaceuticals
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Advanced Solid Tumor
Metastatic Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 combin...
Detailed Description
Two-part study: Part A Dose Exploration (Parts A1 and A2) and Part B Combination Expansion. Part A Dose Exploration: * Part A1 - a monotherapy dose exploration to determine the monotherapy recommend...
Eligibility Criteria
Inclusion
- Inclusion 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, there is no SoC available to convey clinical benefit.
- 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:
- 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
- Exclusion Criteria
- 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
Exclusion
Key Trial Info
Start Date :
November 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2028
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT06108050
Start Date
November 7 2023
End Date
May 31 2028
Last Update
December 16 2025
Active Locations (10)
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1
California Cancer Associates for Research and Excellence
Encinitas, California, United States, 92024
2
California Cancer Associates for Research and Excellence
Fresno, California, United States, 93270
3
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
4
Florida Cancer Specialists
Orlando, Florida, United States, 32827