JAB-2485 Activity in Adult Patients With Advanced Solid Tumors

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

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

Study Overview

• Status: Recruiting
• Conditions: Solid Tumors; ER+ Breast Cancer; ARID1A Gene Mutation; Triple Negative Breast Cancer, TNBC; Small Cell Lung Cancer, SCLC
• Intervention / Treatment: Drug: JAB-2485 (Aurora A inhibitor)

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).

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Jacobio Pharmaceuticals; Phone Number: (781) 918-6670; Email: clinicaltrials@jacobiopharma.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100101
      • Recruiting
      • Cancer Hospital Chinese Academy of Medical Sciences
    • Beijing, Beijing Municipality, China, 100101
      • Recruiting
      • Peking University Third Hospital
  • Jilin
    • Changchun, Jilin, China, 130000
      • Recruiting
      • Jilin Cancer Hospital
  • Shandong
    • Jinan, Shandong, China, 250117
      • Recruiting
      • Shandong Cancer Hospital
• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Health System
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University
  • Texas
    • Dallas, Texas, United States, 75230
      • Recruiting
      • Mary Crowley Cancer Research
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • University of Utah Huntsman Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JAB-2485 monotherapy, Phase 1, Dose Escalation; Dose escalation of JAB-2485 will be administered as monotherapy to determine the MTD and RP2D.	Drug: JAB-2485 (Aurora A inhibitor); Administered orally
Experimental: JAB-2485 monotherapy, Phase 2a, Dose Expansion; JAB-2485 will be administered as monotherapy in patients with specific tumor types to evaluate the preliminary antitumor activity.	Drug: JAB-2485 (Aurora A inhibitor); Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Jacobio Pharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: August 4, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Aurora A inhibitor; ARID1A Gene Mutation
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Skin Diseases; Breast Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Breast Neoplasms; Skin and Connective Tissue Diseases; Small Cell Lung Carcinoma; Triple Negative Breast Neoplasms
• Other Study ID Numbers: JAB-2485-1001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No