JAB-2485 Activity in Adult Patients With Advanced Solid Tumors

NCT05490472 | Recruiting Phase 1 FDA Drug

• 1 other identifier: JAB-2485-1001
• Study Type: interventional
• Target: 102
• Locations: 2 countries
• Sites: 8

Brief Summary

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

Conditions

Solid Tumors; ER+ Breast Cancer; Triple Negative Breast Cancer, TNBC; ARID1A Gene Mutation; Small Cell Lung Cancer, SCLC

Keywords

Aurora A inhibitor; ARID1A Gene Mutation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (13)

• Dose Escalation phase: Objective Response Rate (ORR)

  Up to 3 years from baseline to RECIST confirmed Progressive Disease (PD)

• Dose Escalation and Dose Expansion phase: Time to response (TTR)

  Up to 3 years

• Dose Escalation phase: Duration of Response (DOR)

  Up to 3 years

• Dose Escalation and Dose Expansion phase: peak plasma concentration (Cmax)

  Up to 3 years

• Dose Escalation and Dose Expansion phase: time to peak plasma concentration(Tmax)

  Up to 3 years

Study Arms (2)

JAB-2485 monotherapy, Phase 1, Dose Escalation

EXPERIMENTAL

Dose escalation of JAB-2485 will be administered as monotherapy to determine the MTD and RP2D.

Drug: JAB-2485 (Aurora A inhibitor)

JAB-2485 monotherapy, Phase 2a, Dose Expansion

EXPERIMENTAL

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)

Interventions

JAB-2485 (Aurora A inhibitor) DRUG

Administered orally

JAB-2485 monotherapy, Phase 1, Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jacobio Pharmaceuticals Co., Ltd.: lead

Study Sites (8)

Henry Ford Health System

Detroit, Michigan, 48202, United States

RECRUITING

Washington University

St Louis, Missouri, 63110, United States

RECRUITING

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

RECRUITING

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100101, China

RECRUITING

Peking University Third Hospital

Beijing, Beijing Municipality, 100101, China

RECRUITING

Jilin Cancer Hospital

Changchun, Jilin, 130000, China

RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Jacobio Pharmaceuticals

CONTACT

(781) 918-6670; clinicaltrials@jacobiopharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: August 5, 2022
• Study Start: December 20, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 9, 2026

Record last verified: 2025-11

Locations

US (4); CN (4)