Trial Title:
A Study of JZP815 Oral Capsules in Adult Participants With Advanced or Metastatic Solid Tumors Harboring Mitogen Activated Protein Kinase (MAPK) Pathway Alterations to Investigate the Safety, Dosing, and Antitumor Activity of JZP815
NCT ID:
NCT05557045
Condition:
Advanced Cancer
Metastatic Cancer
Solid Tumor
Conditions: Official terms:
Neoplasm Metastasis
Conditions: Keywords:
Advanced Cancer
Metastatic Cancer
Solid Tumor
JZP815
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:
JZP815
Description:
JZP815 will be administered as oral capsules to participants BID approximately 12 hours
apart, in the morning and in the evening. QD dosing may also be investigated, if
supported by PK data.
Arm group label:
Dose Exploration (Part A): JZP815
Arm group label:
Expansion (Part B): JZP815
Summary:
This phase 1 study will investigate the safety, dosing, and initial antitumor activity of
JZP815 in participants with advanced or metastatic solid tumors harboring alterations in
the MAPK pathway.
Detailed description:
This first-in-human study will consist of two parts: Part A and Part B.
Part A will characterize the safety and tolerability of JZP815, assess pharmacokinetics
(PK) profile, and determine a recommended phase 2 dose (RP2D) to be further investigated
in the Expansion phase (Part B).
Part B will further investigate the RP2D determined in Part A, and assess antitumor
activity in various subsets of disease (based on mutation and/or tumor type) in which the
mechanism of action of JZP815 is applicable.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Participant must be ≥ 18 years of age, at the time of signing the informed consent
- Participants who have histological or cytological diagnosis of an advanced or
metastatic solid tumor carrying a documented, clinically significant, MAPK pathway
alteration
- Participants must have exhausted all available standard of care therapies, or in the
opinion of the investigator would be unlikely to tolerate or derive clinically
meaningful benefit from available standard of care therapy
- Performance status (ECOG) of 0 or 1, measured within 72 hours before start of
treatment. For Arm 7 (NRAS Q61 mutated anaplastic thyroid cancer) in Part B
(Expansion), ECOG of 0 to 2, measured within 72 hours before the start of treatment.
- Must have measurable disease by RECIST v1.1
- Tumor must be safely amenable to core needle or excisional biopsy (applies only to
participants enrolled in Pre-Expansion cohorts)
- Adequate organ function
- Expected life expectancy of at least 12 weeks
- For each arm in Part B (Expansion), participants must be diagnosed with the tumor
type(s) carrying the mutation(s) specified and meet protocol specified requirements
for prior therapy
- Male participants must agree to refrain from donating sperm plus either be abstinent
from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a
long term and persistent basis) and agree to remain abstinent or must agree to use
contraception
- Female participants are eligible to participate if she is not pregnant or
breastfeeding, and one of the following conditions applies: is a women of
nonchildbearing potential (WONCBP) or is a women of childbearing potential (WOCBP)
and using a contraceptive method that is highly effective during the study
intervention period and for at least 3 months after the last dose of study
intervention and agrees not to donate eggs
- A WOCBP must have a negative highly sensitive pregnancy test (urine or serum) within
3 days before the first dose of study intervention
- Capable of giving signed informed consent
Exclusion Criteria:
- Known uncontrolled brain metastases. Stable brain metastases either treated or being
treated with a stable dose of steroids/anticonvulsants, with no dose change in the
previous 4 weeks, are permitted
- Active fungal, bacterial and/or known viral infection including HIV or Hepatitis A,
B, C
- Concomitant malignancies or previous malignancies with less than 2 years
disease-free interval at the time of enrollment, with the exception of
non-metastatic, non-melanomatous skin cancers, carcinoma in-situ, melanoma in-situ,
prostate cancer with undetectable PSA, indolent thyroid cancer that are adequately
treated
- Has clinically significant (ie, active) cardiovascular disease: cerebral vascular
accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months
prior to enrollment), unstable angina, congestive heart failure (> New York Heart
Association Classification Class II), QTc ≥ 470 msec, or serious cardiac arrhythmia
requiring medication
- Uncontrolled or severe intercurrent medical condition
- Gastrointestinal condition that could impair absorption of study intervention or
inability to ingest study intervention
- In the judgement of the investigator, any important medical illness or abnormal
laboratory finding that would increase the risk of participating in this study
- Received any cancer directed therapy (chemotherapy, hormonal therapy, biologic,
etc.) within 28 days or 5 half-lives (whichever is shorter) of starting study
intervention. For Arm 7 (NRAS Q61 mutated anaplastic thyroid cancer) in Part B
(Expansion), participants who have received radio-sensitizing chemotherapy (low-dose
chemotherapy) are permitted a wash-out period of 7 days or 5 half-lives, whichever
is shorter (a discussion with the sponsor is required). Participants who have
received radiotherapy must have recovered from acute toxicities associated with
treatment.
- Use of any products or medicines known to be strong or moderate inducers or
inhibitors of CYP3A4, which cannot be discontinued at least 4 weeks or 5 half-lives
(whichever is shorter) before starting study intervention, or planned use at any
time during the study
- Use of proton pump inhibitors (eg, omeprazole) and histamine-2 receptor antagonists
(eg, famotidine), which cannot be discontinued at least 2 weeks before first dose,
or planned use at any time during the study
- Concurrent therapy with any other investigational agent
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
SCRI HealthOne
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Facility:
Name:
Florida Cancer Specialists - Lake Nona
Address:
City:
Orlando
Zip:
32827
Country:
United States
Status:
Recruiting
Facility:
Name:
Florida Cancer Specialists - Sarasota
Address:
City:
Sarasota
Zip:
34232
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Chicago
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Recruiting
Facility:
Name:
Icahn School of Medicine at Mount Sinai
Address:
City:
New York
Zip:
10029
Country:
United States
Status:
Recruiting
Facility:
Name:
Oklahoma University
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Recruiting
Facility:
Name:
Sidney Kimmel Cancer Center
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Recruiting
Facility:
Name:
Tennessee Oncology - Nashville
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Start date:
October 10, 2022
Completion date:
April 1, 2028
Lead sponsor:
Agency:
Jazz Pharmaceuticals
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/NCT05557045
