JAB-2485 Activity in Adult Patients With Advanced Solid Tumors

Launched by JACOBIO PHARMACEUTICALS CO., LTD. · Aug 4, 2022

Keywords

ClinConnect Summary

The clinical trial titled "JAB-2485 Activity in Adult Patients With Advanced Solid Tumors" is investigating a new treatment called JAB-2485 for adults with advanced solid tumors, including different types of breast cancer and small cell lung cancer. The goal of this study is to determine how safe this treatment is and how well it can be tolerated by patients. The trial is currently recruiting participants aged 65 to 74, and it is open to individuals of all genders who have specific types of tumors that have not responded well to previous treatments.

To participate, patients need to have a certain level of health and must provide a sample of their tumor. They should also have at least one measurable tumor and be able to take medication by mouth. However, individuals with certain serious health issues, active infections, or specific heart conditions cannot join the trial. If eligible, participants can expect to receive the JAB-2485 treatment and be closely monitored for any side effects or reactions. This trial is an important step in finding new options for patients with challenging cancer diagnoses.

Gender

ALL

Eligibility criteria

• 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