JAB-2485 Activity in Adult Patients With Advanced Solid Tumors

Description

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

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Study Overview

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Study Details

Study overview

This study is to evaluate the safety and tolerability of JAB-2485 monotherapy in adult participants 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

JAB-2485 Activity in Adult Patients With Advanced Solid Tumors

Condition
Solid Tumors
Intervention / Treatment

-

Contacts and Locations

Dallas

Mary Crowley Cancer Research, Dallas, Texas, United States, 75230

Salt Lake City

University of Utah Huntsman Cancer Institute, Salt Lake City, Utah, United States, 84112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Jacobio Pharmaceuticals Co., Ltd.,

Jacobio Pharmaceuticals, STUDY_DIRECTOR, Jacobio Pharmaceuticals

Study Record Dates

2026-08