Clinical trial NCT04587479: A First-in-Human Study of JAB-8263 in Adult Patients With Advanced Solid Tumors
Official title: A Phase 1, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-8263 in Adult Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Solid Tumors, Adult
Lead sponsor: Jacobio Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-10-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase 1, first-in-human, open-label study of JAB-8263 to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D) and assess the DLT. 30 subjects with advanced solid tumor will be enrolled.

Detailed description: JAB-8263 is a small-molecule inhibitor of the highly conserved bromodomain pockets of the bromodomain and extraterminal (BET) proteins.

The objectives of this study are:

To determine the maximum-tolerated dose (MTD) and assess the dose-limiting toxicity (DLT) of JAB-8263 as a single agent to adult subjects with advanced solid tumors To assess the safety and tolerability of JAB-8263 To characterize the pharmacokinetic (PK) parameters and pharmacodynamics (PDc) To evaluate preliminary antitumor activity of JAB-8263

Eligibility criteria: Inclusion Criteria:

Subjects must meet all the following criteria in order to be included in the research study:

1. Subject must be ≥18 years-of-age at the time of signature of the informed consent form (ICF).
2. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
3. Subjects with histologically or cytologically confirmed advanced solid tumors which have progressed despite standard therapy(ies), or are intolerant to standard therapy(ies), or have a tumor for which no standard therapy(ies) exists.
4. Subjects with life expectancy ≥3 months.
5. Patients must have at least one measurable lesion as defined by RECIST v1.1.
6. Patients who have sufficient baseline organ function.

Exclusion Criteria:

1. History (≤3 years) of cancer that is histologically distinct from the cancer under study.
2. Known serious allergy to investigational drug or excipients
3. Active brain or spinal metastases
4. History of pericarditis or Grade ≥2 pericardial effusion
5. History of interstitial lung disease.
6. History of Grade ≥2 active infections within 2 weeks
7. Known human immunodeficiency virus (HIV) infection
8. Seropositive for hepatitis B virus (HBV)
9. Seropositive for hepatitis C virus (HCV), or HCV-RNA viral levels are not detectable.
10. Any severe and/or uncontrolled medical conditions
11. History of myocardial infarction, unstable angina pectoris, coronary artery bypass graft, or cerebrovascular accident
12. Impaired cardiac function or clinically significant cardiac diseases
13. QTcF \>470 msec at screening
14. History of medically significant thromboembolic events or bleeding diathesis
15. Unresolved Grade \>1 toxicity
16. History of malignant biliary obstruction
17. Pregnant or breast-feeding

Primary outcomes:
measure: Number of participants with dose limiting toxicities
timeFrame: Approximately 2.5 years
measure: Find Recommended Phase 2 Dose (RP2D) of JAB-8263
timeFrame: Approximately 2.5 years
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: Approximately 2.5 years
measure: Area under the curve
timeFrame: Approximately 2.5 years
measure: Cmax
timeFrame: Approximately 2.5 years
measure: Tmax
timeFrame: Approximately 2.5 years
measure: T1/2
timeFrame: Approximately 2.5 years
measure: Objective response rate ( ORR )
timeFrame: Approximately 2.5 years
measure: Duration of response ( DOR )
timeFrame: Approximately 2.5 years
Other outcomes:
Locations:
city: Denver
country: United States
facility: SCRI HeatlthONE
state: Colorado
city: Lake City
country: United States
facility: Florida Cancer Center, Lake Mary
state: Florida
city: Nashville
country: United States
facility: Tennessee Oncology Nashville
state: Tennessee
Study officials:
affiliation: Jacobio Pharmaceuticals
name: Jacobio Pharmaceuticals
role: STUDY_DIRECTOR
References: