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Brief Title: Study of LM-061 in Subjects in Advanced Tumors
Official Title: A Phase I, First-in-Human, Open-Label, Dose Escalation Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-061 Tablet in Subjects With Advanced Tumors
Study ID: NCT04737122
Brief Summary: This is a phase I, open-label, dose escalation study to evaluate the safety, tolerability, PK, and preliminary efficacy of LM-061 in subjects with advanced tumors.
Detailed Description: This is a phase I, open-label, dose escalation study to evaluate the safety, tolerability, PK, and preliminary efficacy of LM-061 in subjects with advanced tumors. The study schedule includes screening visit (28 days prior to accept the investigational medicinal product (IMP)), treatment visit (accept IMP for the first time to the end of treatment (EOT)/early withdrawal), and follow-up visit (28 days after the EOT/early withdrawal).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
St George Private Hospital, Kogarah, New South Wales, Australia
Name: Vinod Ganju
Affiliation: Peninsula & South Eastern Hematology and Oncology group
Role: PRINCIPAL_INVESTIGATOR
Name: Ganessan Kichenadasse
Affiliation: Southern Oncology Clinical Research Unit
Role: PRINCIPAL_INVESTIGATOR
Name: Paul De Souza
Affiliation: St George Private Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Gary Richardson
Affiliation: Cabrini Health
Role: PRINCIPAL_INVESTIGATOR