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Trial Title:
JAB-2485 Activity in Adult Patients With Advanced Solid Tumors
NCT ID:
NCT05490472
Condition:
Solid Tumors
ER+ Breast Cancer
Triple Negative Breast Cancer, TNBC
ARID1A Gene Mutation
Small Cell Lung Cancer, SCLC
Conditions: Official terms:
Breast Neoplasms
Small Cell Lung Carcinoma
Triple Negative Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
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:
JAB-2485 (Aurora A inhibitor)
Description:
Administered orally
Arm group label:
JAB-2485 monotherapy, Phase 1, Dose Escalation
Intervention type:
Drug
Intervention name:
JAB-2485 (Aurora A inhibitor)
Description:
Administered orally
Arm group label:
JAB-2485 monotherapy, Phase 2a, Dose Expansion
Summary:
This study is to evaluate the safety and tolerability of JAB-2485 monotherapy in adult
participants with advanced solid tumors.
Detailed description:
The primary objective of this study is to evaluate the safety and tolerability of
JAB-2485 monotherapy to determine the maximum tolerated dose (MTD) and recommended Phase
2 dose (RP2D) during Dose Escalation phase when administered in participants with
advanced solid tumors; then to further evaluate preliminary antitumor activity of
JAB-2485 monotherapy at the RP2D during Dose Expansion phase in patients with advanced
solid tumors such as ER+ breast cancer, triple negative breast cancer (TNBC), AT-rich
interaction domain 1A (ARID1A) mutant solid tumors and small cell lung cancer (SCLC).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Must be able to provide an archived tumor sample
- Must have histologically or cytologically confirmed metastatic or locally advanced
solid tumor
- Dose Expansion phase cohorts must meet specific expression or gene mutation
where indicated
- Must be refractory to or become intolerant of existing therapy(ies) known to provide
clinical benefit for their condition
- Must have at least 1 measurable lesion per RECIST v1.1
- Must have adequate organ functions
- Must be able to swallow and retain orally administered medication
Exclusion Criteria:
- Has central nervous system (CNS) metastases or carcinomatous meningitis, except if
CNS metastases treated and no evidence of radiographic progression or hemorrhage for
at least 28 days
- Active infection requiring systemic treatment within 7 days
- Active hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV
- Any severe and/or uncontrolled medical conditions
- left ventricular ejection fraction (LVEF) ≤50% assessed by echocardiogram (ECHO) or
multigated acquisition scan (MUGA)
- QT interval using Fridericia's formula (QTcF) interval >470 msec
- Experiencing unresolved CTCAE 5.0 Grade >1 toxicities
- Clinically significant eye disorders
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mary Crowley Cancer Research
Address:
City:
Dallas
Zip:
75230
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Utah Huntsman Cancer Institute
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Facility:
Name:
Research site02
Address:
City:
Beijing
Zip:
100101
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research site01
Address:
City:
Changchun
Zip:
130000
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research site03
Address:
City:
Jinan
Zip:
250117
Country:
China
Status:
Not yet recruiting
Start date:
December 20, 2022
Completion date:
August 2026
Lead sponsor:
Agency:
Jacobio Pharmaceuticals Co., Ltd.
Agency class:
Industry
Source:
Jacobio Pharmaceuticals Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05490472
