Clinical trial NCT05490472: JAB-2485 Activity in Adult Patients With Advanced Solid Tumors
Official title: A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-2485 in Adult Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Solid Tumors
ER+ Breast Cancer
Triple Negative Breast Cancer, TNBC
ARID1A Gene Mutation
Small Cell Lung Cancer, SCLC
Lead sponsor: Jacobio Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-08-05
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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).

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

Primary outcomes:
measure: Dose Escalation phase: Number of participants with dose limiting toxicities (DLTs)
timeFrame: First 21 days of Cycle 1
measure: Dose Escalation phase: Number of participants with adverse events (AEs)
timeFrame: Up to 3 years
measure: Dose Expansion phase: Objective Response Rate (ORR)
timeFrame: Up to 3 years from baseline to RECIST confirmed Progressive Disease (PD)
measure: Dose Expansion phase: Duration of Response (DOR)
timeFrame: Up to 3 years
Secondary outcomes:
measure: Dose Escalation phase: Objective Response Rate (ORR)
timeFrame: Up to 3 years from baseline to RECIST confirmed Progressive Disease (PD)
measure: Dose Escalation and Dose Expansion phase: Time to response (TTR)
timeFrame: Up to 3 years
measure: Dose Escalation phase: Duration of Response (DOR)
timeFrame: Up to 3 years
measure: Dose Escalation and Dose Expansion phase: peak plasma concentration (Cmax)
timeFrame: Up to 3 years
measure: Dose Escalation and Dose Expansion phase: time to peak plasma concentration(Tmax)
timeFrame: Up to 3 years
measure: Dose Escalation and Dose Expansion phase: Ctrough
timeFrame: Up to 3 years
measure: Dose Escalation and Dose Expansion phase: Area under the curve (AUC)
timeFrame: Up to 3 years
measure: Dose Escalation and Dose Expansion phase: half-life (t½)
timeFrame: Up to 3 years
measure: Dose Escalation and Dose Expansion phase: total body clearance
timeFrame: Up to 3 years
measure: Dose Expansion phase: Progression Free Survival (PFS)
timeFrame: Up to 3 years
measure: Dose Expansion Phase 2a: Overall Survival (OS)
timeFrame: Up to 3 years
measure: Dose Expansion phase: Disease Control Rate (DCR)
timeFrame: Up to 3 years
measure: Dose Expansion phase: Number of participants with adverse events (AEs)
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Mary Crowley Cancer Research
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Huntsman Cancer Institute
state: Utah
city: Beijing
country: China
facility: Research site02
state: Beijing
city: Changchun
country: China
facility: Research site01
state: Jilin
city: Jinan
country: China
facility: Research site03
state: Shandong
Study officials:
affiliation: Jacobio Pharmaceuticals
name: Jacobio Pharmaceuticals
role: STUDY_DIRECTOR
References: