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Trial Title:
JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid Tumors
NCT ID:
NCT06108050
Condition:
Advanced Solid Tumor
Metastatic Solid Tumor
Conditions: Official terms:
Neoplasms
Pembrolizumab
Conditions: Keywords:
Advanced Solid Tumor
Metastatic Solid Tumor
JZP898
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JZP898
Description:
Investigational drug monotherapy
Arm group label:
Part A1 Dose Exploration: JZP898 monotherapy
Arm group label:
Part A2 Dose Exploration: JZP898 in combination with pembrolizumab
Arm group label:
Part B Combination Expansion: JZP898 in combination with pembrolizumab
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Approved anti-PD1 antibody
Arm group label:
Part A2 Dose Exploration: JZP898 in combination with pembrolizumab
Arm group label:
Part B Combination Expansion: JZP898 in combination with pembrolizumab
Other name:
KEYTRUDA®
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 combination with pembrolizumab in adult participants
with advanced or metastatic solid tumors.
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 recommended
dose and/or maximum tolerated dose (MTD) and safety profile of JZP898.
- Part A2 - a combination dose exploration of JZP898 plus pembrolizumab to determine
the combination recommended dose followed by confirmation of the recommended phase 2
dose (Combination RP2D)
Part B Combination Expansion:
- Part B - combination expansion using a basket design to evaluate clinical antitumor
activity and safety profile of JZP898 in combination with pembrolizumab at the
Combination RP2D identified in Part A2.
Criteria for eligibility:
Criteria:
Inclusion Criteria
- Adult ≥ 18 years of age
- Histological or cytological diagnosis of advanced or metastatic solid tumor.
a. Previously treated participants with solid tumors (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.
- 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 v1.1 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 or interstitial lung disease requiring steroid
treatment.
- 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
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
California Cancer Associates for Research and Excellence
Address:
City:
Encinitas
Zip:
92024
Country:
United States
Status:
Recruiting
Facility:
Name:
California Cancer Associates for Research and Excellence
Address:
City:
Fresno
Zip:
93270
Country:
United States
Status:
Recruiting
Facility:
Name:
Duke University Medical Center - Duke Cancer Institute
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Facility:
Name:
Sidney Kimmel Cancer Center at Thomas Jefferson University Hospital
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Recruiting
Facility:
Name:
SCRI Oncology Partners
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Oncology - Baylor Charles A Sammons Cancer Center
Address:
City:
Dallas
Zip:
75246
Country:
United States
Status:
Recruiting
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Virginia Cancer Specialists
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Start date:
November 7, 2023
Completion date:
May 31, 2028
Lead sponsor:
Agency:
Jazz Pharmaceuticals
Agency class:
Industry
Collaborator:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
Jazz Pharmaceuticals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06108050
