RECRUITING

JAB-2485 Activity in Adult Patients With Advanced Solid Tumors

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Conditions

Solid TumorsER+ Breast CancerTriple Negative Breast Cancer, TNBCARID1A Gene MutationSmall Cell Lung Cancer, SCLC

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2022-12-20
Study Completion:2026-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05490472

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  2. * Must be able to provide an archived tumor sample
  3. * Must have histologically or cytologically confirmed metastatic or locally advanced solid tumor
  4. * Dose Expansion phase cohorts must meet specific expression or gene mutation where indicated
  5. * Must be refractory to or become intolerant of existing therapy(ies) known to provide clinical benefit for their condition
  6. * Must have at least 1 measurable lesion per RECIST v1.1
  7. * Must have adequate organ functions
  8. * Must be able to swallow and retain orally administered medication
  1. * 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
  2. * Active infection requiring systemic treatment within 7 days
  3. * Active hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV
  4. * Any severe and/or uncontrolled medical conditions
  5. * left ventricular ejection fraction (LVEF) ≤50% assessed by echocardiogram (ECHO) or multigated acquisition scan (MUGA)
  6. * QT interval using Fridericia's formula (QTcF) interval \>470 msec
  7. * Experiencing unresolved CTCAE 5.0 Grade \>1 toxicities
  8. * Clinically significant eye disorders

Contacts and Locations

Study Contact

Jacobio Pharmaceuticals
CONTACT
(781) 918-6670
clinicaltrials@jacobiopharma.com
Zhiwen He
CONTACT
Zhiwen.he@jacobiopharma.com

Principal Investigator

Jacobio Pharmaceuticals
STUDY_DIRECTOR
Jacobio Pharmaceuticals

Study Locations (Sites)

Mary Crowley Cancer Research
Dallas, Texas, 75230
United States
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: Jacobio Pharmaceuticals Co., Ltd.

  • Jacobio Pharmaceuticals, STUDY_DIRECTOR, Jacobio Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-20
Study Completion Date2026-08

Study Record Updates

Study Start Date2022-12-20
Study Completion Date2026-08

Terms related to this study

Additional Relevant MeSH Terms

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