Evaluate Preliminary Anti-tumor Activity of Elraglusib in Adult Participants With Advanced Solid Tumors
brief summary
This study is being done to test the safety of elraglusib when taken once a day and to assess: * How the body processes the drug (pharmacokinetics) * Assess potential effects of the drug on heart rhythm * Find the highest daily dose that can be given without causing side effects
detailed description
The study is a Phase 1/2, open label, dose escalation, safety, PK, PD and antitumor activity study of elraglusib tablets in participants aged 18 years or older with a histologically or cytologically confirmed diagnosis of advanced metastatic or progressive malignant solid tumors who are intolerant of or the malignancy is refractory to established therapy know to provide clinical benefit for their condition, or the malignancy has relapsed after standard therapy. Participants must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 measured by computed tomography (CT) scan or MRI to be eligible.
The study's primary objective is to determine the MTD or MAD and DLTs of elraglusib tablets administered daily. The secondary objectives are to study the PK of elraglusib tablets, to evaluate preliminary antitumor activity of elraglusib when administered as tablets, and to establish the RDEs of elraglusib tablets in subsequent development.
official title
Phase 1/2 Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of Elraglusib Oral Tablets in Adult Participants With Advanced Solid Tumors.