Testing ABSK043 single agent for sarcoma

Exclusion

• −Has known active central nervous system (CNS) metastases and/or leptomeningeal disease. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baselineBaselineYour starting measurements, taken before treatment begins.Read more →), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include leptomeningeal disease which is excluded regardless of clinical stability.
• −Has a known history of Human Immunodeficiency Virus (HIV) with detectable viral load.
• −Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected).
• −The subject must be excluded from participating in the trial if the subject:
• −Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
• −Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Use of steroids at physiological dose is allowed (i.e. less than or equal to prednisone 10mg per day)
• −Has had prior treatment with any anti-PD-1, anti-PD-L1 or other antibodies specifically targeting the immune checkpoint pathways.
• −Has had a prior anti-cancer monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → due to agents administered more than 4 weeks earlier.
• −Has active gastrointestinal condition that may affect the absorption of ABSK043, according to investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →.
• −Note: Subjects with ≤ Grade 2 neuropathy or alopecia are an exception to this criterion and may qualify for the study.
• −Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• −Has known history of, or any evidence of active, non-infectious pneumonitis.
• −Has evidence of interstitial lung disease.
• −Has an active infection requiring systemic treatment.
• −Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• −Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• −A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 milliseconds (ms)).
• −A history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
• −The use of concomitant medications that prolong the QT/QTc interval.
• −Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screeningScreeningThe checks done before joining, to see whether a study fits.Read more → or screening visit through 120 days after the last dose of trial treatment.
• −Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
• −Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
• −Has a known additional malignancy within the last 3 years or continues to receive antineoplastic treatment after curative intent surgery. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.