JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJazz Pharmaceuticals
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Sequential
Treatments tested in this trial
JZP898
DrugInvestigational drug monotherapy
Pembrolizumab
DrugAnti-PD1 antibody
Treatment groups
177 Participants
are divided into 3 treatment groupsGroup A: Part A1 Dose Exploration: JZP898 monotherapyExperimental treatment 1 intervention
Group B: Part A2 Dose Exploration: JZP898 in combination with pembrolizumabExperimental treatment 2 interventions
Group C: Part B Combination Expansion: JZP898 in combination with pembrolizumabExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of Participants with Dose Limiting Toxicities in Monotherapy and Combination Therapy
Time frame
Up to 36 months2
Incidence of TEAEs and SAEs in Monotherapy and Combination Therapy
Time frame
Up to 36 months3
Incidence of dose interruptions, discontinuation, and reductions due to TEAEs in Monotherapy and Combination Therapy
Time frame
Up to 36 months4
Objective Response Rate (ORR) As Assessed by the Investigator In Combination Therapy
Time frame
Up to 36 monthsSecondary outcomes
1
Pharmacokinetic Parameter: Maximum Concentration (Cmax) of JZP898 in Monotherapy and Combination Therapy
Time frame
Up to 36 months2
Pharmacokinetic Parameter: Time to Maximum Concentration (Tmax) of JZP898 in Monotherapy and Combination Therapy
Time frame
Up to 36 months3
Pharmacokinetic Parameter: Terminal Elimination Half-life (t½) of JZP898 in Monotherapy and Combination Therapy
Time frame
Up to 36 months4
Pharmacokinetic Parameter: Area Under the Concentration-Time Curve (AUC) of JZP898 in Monotherapy and Combination Therapy
Time frame
Up to 36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jazz Pharmaceuticals
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov