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
- * Males or females aged 18 years or older (≥18 years).
- * Participants with pathologically confirmed advanced solid tumor (who have failed or are intolerant to standard of care).
- * Participants have at least one target lesion as assessed per the RECIST 1.1
- * Tumor tissue from a newly obtained biopsy or archival tumor tissue is required for retrospective detection of B7 homolog 4 (B7-H4) expression by Immunohistochemistry (IHC) in central laboratory and other biomarker analysis. Tissue from a newly obtained biopsy is preferred. If a newly obtained biopsy is not feasible, archival tumor tissue within 2 years prior to the first dose of study drug is acceptable.
- * Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2 and no deterioration within 2 weeks before the first dose.
- * Have a life expectancy of at least 12 weeks.
- * Have received any of B7-H4-targeted therapies.
- * Have received any of cytotoxic chemotherapy drugs, anti-tumor traditional Chinese medicines or other anti-tumor drugs within 28 days prior to the first dose of study drug; or need to continue these drugs during the study.
- * Have received locoregional radiation therapy within 2 weeks prior to the first dose of study drug; more than 30% of bone marrow irradiation or wide-field radiation therapy within 4 weeks prior to the first dose of study treatment.
- * Presence of pleural/abdominal effusion/ascites requiring clinical intervention; presence of pericardial effusion
- * Major surgery within 4 weeks prior to the first dose of study treatment.
- * Evidence of brain metastasis unless asymptomatic.
- * Has inadequate bone marrow reserve or hepatic/renal functions.
- * Mean Fridericia-corrected QT interval (QTcF) \> 470 millisecond (msec) on resting ECG.
- * Evidence of current clinically significant arrhythmias or ECG abnormalities
- * Risk factors of prolonged QTc or arrhythmia events,
- * Left ventricular ejection fraction (LVEF) \< 50%.
- * Have severe, uncontrolled or active cardiovascular disorders, serious or poorly controlled hypertension, clinically significant bleeding symptoms or serious arteriovenous thromboembolic events
- * Any evidence of current Interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or pneumonitis requiring high-dose systemic glucocorticoids.
Ages Eligible for Study
18 Years to
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
No