JAB-2485 Activity in Adult Patients With Advanced Solid Tumors

Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05490472
• Other study ID #: JAB-2485-1001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 20, 2022
• Est. completion date: August 2026

Study information

• Verified date: January 2023
• Source: Jacobio Pharmaceuticals Co., Ltd.
• Contact: Jacobio Pharmaceuticals
• Phone: (781) 918-6670
• Email: clinicaltrials[@]jacobiopharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to evaluate the safety and tolerability of JAB-2485 monotherapy in adult participants with advanced solid tumors.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: August 2026
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ARID1A Gene Mutation
• Breast Neoplasms
• ER+ Breast Cancer
• Small Cell Lung Carcinoma
• Solid Tumors
• Triple Negative Breast Neoplasms

Intervention

Drug:
• JAB-2485 (Aurora A inhibitor)
Administered orally
• JAB-2485 (Aurora A inhibitor)
Administered orally

Locations

Country	Name	City	State
China	Research site02	Beijing	Beijing
China	Research site01	Changchun	Jilin
China	Research site03	Jinan	Shandong
United States	Mary Crowley Cancer Research	Dallas	Texas
United States	University of Utah Huntsman Cancer Institute	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Jacobio Pharmaceuticals Co., Ltd.

Countries where clinical trial is conducted

United States,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Escalation phase: Number of participants with dose limiting toxicities (DLTs)	A DLT is defined as an adverse event (AE) regardless of attribution unless clearly related to underlying disease or extraneous cause during the first 21 days of Cycle 1 (DLT observation period).	First 21 days of Cycle 1
Primary	Dose Escalation phase: Number of participants with adverse events (AEs)	Participants will be assessed for incidence and severity of AEs according to NCI-CTCAE v5.0	Up to 3 years
Primary	Dose Expansion phase: Objective Response Rate (ORR)	ORR is defined as the percentage of participants with partial response (PR) or complete response (CR) based on RECIST v1.1	Up to 3 years from baseline to RECIST confirmed Progressive Disease (PD)
Primary	Dose Expansion phase: Duration of Response (DOR)	DOR is defined as the time from the participants initial objective response (CR or PR) to disease progression per CTCAE v1.1 or death due to any cause, whichever occurs first.	Up to 3 years
Secondary	Dose Escalation phase: Objective Response Rate (ORR)	ORR is defined as the percentage of participants with PR or CR based on RECIST v1.1	Up to 3 years from baseline to RECIST confirmed Progressive Disease (PD)
Secondary	Dose Escalation and Dose Expansion phase: Time to response (TTR)	TTR is defined as the interval of time between the date of first treatment to the first documented response (CR or PR) as determined by investigator assessment per RECIST v1.1	Up to 3 years
Secondary	Dose Escalation phase: Duration of Response (DOR)	DOR is defined as the time from the participants initial objective response (CR or PR) to disease progression per CTCAE v1.1 or death due to any cause, whichever occurs first	Up to 3 years
Secondary	Dose Escalation and Dose Expansion phase: peak plasma concentration (Cmax)	Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples, including peak plasma concentration (Cmax)	Up to 3 years
Secondary	Dose Escalation and Dose Expansion phase: time to peak plasma concentration(Tmax)	Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples. Including time to peak plasma concentration (tmax)	Up to 3 years
Secondary	Dose Escalation and Dose Expansion phase: Ctrough	Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples. Including pre-dose through concentration (Ctrough)	Up to 3 years
Secondary	Dose Escalation and Dose Expansion phase: Area under the curve (AUC)	Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples. Including area under the plasma concentration versus time curve (AUC)	Up to 3 years
Secondary	Dose Escalation and Dose Expansion phase: half-life (t½)	Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples. Including half-life (t½)	Up to 3 years
Secondary	Dose Escalation and Dose Expansion phase: total body clearance	Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples. Including total body clearance	Up to 3 years
Secondary	Dose Expansion phase: Progression Free Survival (PFS)	PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression per RECIST v1.1 or death which occurs first.	Up to 3 years
Secondary	Dose Expansion Phase 2a: Overall Survival (OS)	OS is defined as the length of time between the date of first treatment to the date of death	Up to 3 years
Secondary	Dose Expansion phase: Disease Control Rate (DCR)	DCR is defined as percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1	Up to 3 years
Secondary	Dose Expansion phase: Number of participants with adverse events (AEs)	Participants will be assessed for incidence and severity of AEs according to NCI-CTCAE v5.0	Up to 3 years